Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study

March 27, 2024 updated by: Ancora Heart, Inc.

Randomized Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study

Prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The CORCINCH-HF Study is a prospective, randomized, open-label, multicenter, international, clinical safety and efficacy investigation of the AccuCinch Ventricular Restoration System.

Subjects will be randomized in a 1:1 ratio:

  1. Treatment group: AccuCinch Ventricular Restoration System plus guideline-directed medical therapy (GDMT) (n~200)
  2. Control group: Guideline-directed medical therapy (GDMT) (n~200)

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belarus
      • Minsk, Belarus, 220036
        • Recruiting
        • Republican Scientific and Practical Centre of Cardiology
        • Contact:
        • Principal Investigator:
          • Prof. Alena Kurlianskaya, MD, PhD
  • Belgium
      • Aalst, Belgium, 9300
        • Recruiting
        • OLV Heart Centre
        • Contact:
        • Principal Investigator:
          • Jozef Bartunek, MD, PhD
      • Brugge, Belgium
        • Recruiting
        • AZ Sint-Jan-Oostende AV Campus Brugge
        • Contact:
        • Principal Investigator:
          • Jan Van Der Heijden, MD, PhD
  • Czechia
      • Brno, Czechia, 60200
        • Recruiting
        • St. Anne's University Hospital
        • Principal Investigator:
          • Ota Hlinomaz, MD
      • Prague, Czechia
        • Recruiting
        • Na Homolce Hospital
        • Contact:
        • Principal Investigator:
          • Prof. Petr Neužil, MD, CSc, FESC
  • France
      • Marseille, France, 13005
        • Recruiting
        • Hopital de la Timone
        • Principal Investigator:
          • Thomas Cuisset, MCU-PH, MD, PhD
      • Rennes, France, 35033
        • Recruiting
        • CHU de Rennes - Hôpital Pontchaillou
        • Principal Investigator:
          • Guillaume Leurent, MD
      • Toulouse, France, 31300
        • Recruiting
        • Clinique-Pasteur
        • Principal Investigator:
          • Nicolas Dumonteil, MD
  • Netherlands
      • Nieuwegein, Netherlands
        • Recruiting
        • St. Antonius Ziekenhuis
        • Contact:
        • Principal Investigator:
          • Benno Rensing, MD
      • Rotterdam, Netherlands
        • Recruiting
        • Erasmus Medical Center
        • Principal Investigator:
          • Nicolas Van Mieghem, MD, PhD
        • Contact:
  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • Institute of Cardiovascular Diseases of Vojvodina
        • Contact:
          • Teodora Pantic, MD
        • Principal Investigator:
          • Prof. Milovan Petrović
      • Belgrade, Serbia, 11000
        • Not yet recruiting
        • Institute of Cardiovascular Diseases
        • Contact:
          • Una Radak, MD
        • Principal Investigator:
          • Dragana Košević, MD
      • Belgrade, Serbia, 11000
        • Not yet recruiting
        • University Clinical Centre of Serbia
        • Principal Investigator:
          • Prof. Arsen Ristić, MD, PhD
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35243
        • Recruiting
        • Grandview Medical Group Research, LLC
        • Contact:
        • Principal Investigator:
          • Juan Bernal, MD
      • Birmingham, Alabama, United States, 35294
        • Withdrawn
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Phoenix Cardiovascular Research Group
        • Principal Investigator:
          • Timothy Byrne, DO
        • Contact:
      • Tucson, Arizona, United States, 85712
        • Recruiting
        • Tucson Medical Center
        • Contact:
        • Principal Investigator:
          • Thomas E. Waggoner, DO
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Not yet recruiting
        • Baptist Health Heart Failure & Transplant Institute
        • Principal Investigator:
          • Patrick Campbell, MD
        • Contact:
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • University of California San Diego
        • Contact:
        • Principal Investigator:
          • Jorge Silva Enciso, MD
      • La Jolla, California, United States, 92121
      • Los Angeles, California, United States, 90033
        • Recruiting
        • University of Southern California
        • Contact:
        • Principal Investigator:
          • Ajay Vaidya, MD
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco
        • Principal Investigator:
          • Liviu Klein, MD
        • Contact:
      • San Francisco, California, United States, 94115
        • Recruiting
        • Kaiser Permanente San Francisco
        • Contact:
        • Principal Investigator:
          • Van Selby, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Withdrawn
        • University of Colorado
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Recruiting
        • Hartford Health
        • Contact:
        • Principal Investigator:
          • Bryan Piccirillo, MD
      • New Haven, Connecticut, United States, 06519
        • Recruiting
        • Yale University
        • Contact:
        • Principal Investigator:
          • Lavanya Bellumkonda, MD
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • MedStar Health Research Institute
        • Contact:
        • Principal Investigator:
          • Miguel Pinilla-Vera, MD
    • Florida
      • Atlantis, Florida, United States, 33462
      • Largo, Florida, United States, 33770
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Contact:
        • Principal Investigator:
          • Mrudula Munagala, MD
      • Pensacola, Florida, United States, 32504
        • Recruiting
        • Ascension Sacred Heart
        • Contact:
          • Ashley Corlies
        • Principal Investigator:
          • Rohit Amin, MD
      • Tampa, Florida, United States, 33606
        • Recruiting
        • University of South Florida
        • Principal Investigator:
          • Fadi Matar, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30342
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University
        • Principal Investigator:
          • Kendra Grubb, MD
        • Contact:
      • Atlanta, Georgia, United States, 30309
        • Withdrawn
        • Piedmont Heart Institute
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Medical Center
        • Contact:
        • Principal Investigator:
          • Gene Kim, MD
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • James Flaherty, MD
      • Downers Grove, Illinois, United States, 60515
        • Recruiting
        • Advocate Good Samaritan Hospital
        • Contact:
        • Principal Investigator:
          • Dominick Bufalino, MD
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Recruiting
        • Cardiovascular Research Institute of Kansas
        • Contact:
        • Principal Investigator:
          • Bassem Chehab, MD
    • Kentucky
      • Louisville, Kentucky, United States, 40216
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Recruiting
        • Our Lady of the Lake Regional Medical Center
        • Principal Investigator:
          • Jorge Castellanos, MD
        • Contact:
      • Houma, Louisiana, United States, 70360
        • Recruiting
        • Cardiovascular Institute of the South
        • Principal Investigator:
          • Peter Fail, MD
        • Contact:
        • Contact:
    • Maine
      • Bangor, Maine, United States, 04401
        • Recruiting
        • Northern Light Eastern Maine Medical Center
        • Contact:
        • Principal Investigator:
          • Matthew McKay, MD
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Not yet recruiting
        • University of Maryland Medical Center
        • Principal Investigator:
          • Albert J Hicks, III, MD, MPH
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • Ignacio Inglessis-Azuaje, MD
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Arthur Rashad Garan, MD
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • University of Massachusetts
        • Contact:
        • Principal Investigator:
          • Nikolaos Kakouros, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
        • Principal Investigator:
          • Abbas Bitar, MD
      • Grand Rapids, Michigan, United States, 49503
      • Royal Oak, Michigan, United States, 48073
        • Recruiting
        • William Beaumont Hospital
        • Contact:
        • Principal Investigator:
          • Ivan Hanson, MD
      • Southfield, Michigan, United States, 48075
        • Recruiting
        • Ascension Providence Hospital
        • Principal Investigator:
          • Shukri David, MD
        • Contact:
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Metropolitan Heart and Vascular Institute & Mercy Hosp
        • Contact:
        • Principal Investigator:
          • Todd Drexel, MD
      • Minneapolis, Minnesota, United States, 55414
        • Recruiting
        • University of Minnesota
        • Principal Investigator:
          • Gregory Helmer, MD
        • Contact:
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Minneapolis Heart Institute Foundation
        • Contact:
        • Principal Investigator:
          • Peter Eckman, MD
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • Jackson Heart Clinic
        • Principal Investigator:
          • William Crowder, MD
        • Contact:
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University in St. Louis
        • Principal Investigator:
          • Justin Vader, MD
        • Contact:
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • Recruiting
        • Deborah Heart & Lung
        • Principal Investigator:
          • Richard Kovach, MD
        • Contact:
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
        • Principal Investigator:
          • Ryan Kaple, MD
        • Contact:
      • Morristown, New Jersey, United States, 07960
        • Terminated
        • Morristown Medical Center
    • New York
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Contact:
        • Principal Investigator:
          • Yogita Rochlani, MD
      • Buffalo, New York, United States, 14203
        • Recruiting
        • University at Buffalo
        • Principal Investigator:
          • Vijay Iyer, MD
        • Contact:
      • Manhasset, New York, United States, 11030
        • Recruiting
        • Northwell Health
        • Contact:
        • Principal Investigator:
          • Gerin Stevens, MD
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Hospital
        • Contact:
        • Principal Investigator:
          • Vivek Reddy, MD
      • New York, New York, United States, 10016
      • New York, New York, United States, 10032
        • Recruiting
        • CUMC/New York Presbyterian Hospital
        • Contact:
        • Principal Investigator:
          • Gabriel Sayer, MD
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Medicine-New York Presbyterian Hospital
        • Contact:
        • Principal Investigator:
          • Mark Reisman, MD
      • Poughkeepsie, New York, United States, 12601
        • Recruiting
        • Vassar Brothers Medical Center
        • Principal Investigator:
          • Rajeev Narayan, MD
        • Contact:
      • Roslyn, New York, United States, 11576
        • Recruiting
        • St. Francis Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • George Petrossian, MD
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • NC Heart and Vascular Research, LLC
        • Contact:
        • Principal Investigator:
          • Robert Lee Jobe, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45219
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Principal Investigator:
          • Rishi Puri, MD PhD FRACP
        • Contact:
      • Cleveland, Ohio, United States, 44106
        • Withdrawn
        • UH Cleveland Medical Center
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University
        • Contact:
        • Principal Investigator:
          • Konstantinos D Boudoulas, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Recruiting
        • Oklahoma Heart Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mohammad Ghani, MD
      • Oklahoma City, Oklahoma, United States, 73112
        • Recruiting
        • Integris Baptist Medical Center
        • Contact:
        • Principal Investigator:
          • Douglas Horstmanshof, MD
      • Tulsa, Oklahoma, United States, 74104
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
        • Principal Investigator:
          • Johannes Steiner, MD
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence St. Vincent Medical Center
        • Contact:
        • Principal Investigator:
          • Jacob Abraham, MD
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Geisinger Clinic
        • Principal Investigator:
          • Shikhar Agarwal, MD
        • Contact:
      • Harrisburg, Pennsylvania, United States, 17101
        • Withdrawn
        • Pinnacle Health Cardiovascular Institute
      • Hershey, Pennsylvania, United States, 17033
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University
        • Principal Investigator:
          • Nicholas Ruggiero, MD
        • Contact:
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny General Hospital
        • Contact:
        • Principal Investigator:
          • Manreet Kanwar, MD
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • UPMC Heart and Vascular Institute
        • Principal Investigator:
          • Catalin Toma, MD
        • Contact:
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • Recruiting
        • Rhode Island Hospital
        • Contact:
        • Principal Investigator:
          • Paul Gordon, MD
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Principal Investigator:
          • Daniel Steinberg, MD
        • Contact:
      • Columbia, South Carolina, United States, 29203
    • Tennessee
      • Knoxville, Tennessee, United States, 37934
        • Recruiting
        • Tennova Healthcare-Turkey Creek Medical Center
        • Principal Investigator:
          • Malcolm T Foster, III, MD
        • Contact:
      • Nashville, Tennessee, United States, 87232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
        • Principal Investigator:
          • Colin Barker, MD
      • Nashville, Tennessee, United States, 37221
    • Texas
      • Austin, Texas, United States, 78756
      • Austin, Texas, United States, 78705
        • Recruiting
        • Ascension Texas Cardiovascular
        • Principal Investigator:
          • Ernest Haeusslein, MD
      • Dallas, Texas, United States, 75226
        • Recruiting
        • Baylor Scott & White Research Institute
        • Contact:
        • Principal Investigator:
          • Yashasvi Chugh, MD
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77004
        • Recruiting
        • Houston Heart
        • Contact:
        • Principal Investigator:
          • Pranav Loyalka, MD
      • Houston, Texas, United States, 77020
        • Recruiting
        • Baylor College of Medicine St. Luke's Medical Center
        • Contact:
        • Principal Investigator:
          • Ajith Nair, MD
      • Houston, Texas, United States, 77030
      • Lubbock, Texas, United States, 79430
        • Recruiting
        • Texas Tech University Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Mohammad (Mac) Ansari, MD
      • Plano, Texas, United States, 75093
        • Terminated
        • Baylor Scott & White
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Methodist Healthcare System, San Antonio
        • Contact:
        • Principal Investigator:
          • Jorge Alvarez, MD
    • Utah
      • Salt Lake City, Utah, United States, 84109
        • Recruiting
        • Intermountain Medical Center
        • Contact:
        • Principal Investigator:
          • Brian Whisenant, MD
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia Health System
        • Contact:
        • Principal Investigator:
          • Mohammad Abuannadi, MD
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Sentara Norfolk General Hospital
        • Principal Investigator:
          • Amit Badiye, MD
        • Contact:
      • Richmond, Virginia, United States, 23225
        • Recruiting
        • CJW Chippenham Medical Center
        • Contact:
        • Principal Investigator:
          • James Garnett, MD
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Carilion Roanoke Memorial Hospital
        • Principal Investigator:
          • Jason Foerst, MD
        • Contact:
      • Winchester, Virginia, United States, 22601
        • Recruiting
        • Valley Health Winchester
        • Principal Investigator:
          • Jason Call, MD
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98195
        • Not yet recruiting
        • University of Washington
        • Contact:
        • Principal Investigator:
          • Christine Chung, MD
      • Spokane, Washington, United States, 99204
        • Recruiting
        • Providence Sacred Heart Medical Center
        • Contact:
        • Principal Investigator:
          • James Mudd, MD
    • West Virginia
      • Charleston, West Virginia, United States, 25304
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College Of Wisconsin
        • Contact:
        • Principal Investigator:
          • Saif Anwaruddin, MD
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Aurora St. Luke's Medical Center
        • Contact:
        • Principal Investigator:
          • Suhail Allaqaband, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18-years or older
  2. Ejection Fraction: ≥20% and ≤40% measured by transthoracic echocardiography (TTE) and assessed by an echocardiography (echo) core lab
  3. LV end-diastolic diameter ≥55 mm measured by TTE and assessed by an echo core lab

  4. Symptom Status:

    1. NYHA III,
    2. NYHA ambulatory IV, or
    3. NYHA II with a heart failure hospitalization within the prior 12 months (of signing the consent)
  5. Able to complete six-minute walk test with distance between 100 m and 450 m.

  6. Diagnosis and treatment for heart failure should be established at least 90 days before the date of consent. Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current guidelines as standard-of-care for Heart Failure therapy, with any intolerance documented.

    1. "Stable" is defined as no more than a 100% increase or a 50% decrease of total daily doses. Medication changes within this range do not require any additional waiting before the screening assessments
    2. When a total daily dose increase or decrease exceeds that which is considered stable, the screening TTE and CT will be postponed 30 days after the medication change
    3. When additional titration is required to optimize a subject's medication that exceeds what is considered stable, the screening TTE and CT will be postponed at least 30 days after achieving the optimal dose (provided the optimal dose remains outside of the stable parameters)
    4. When a dose-for-dose equivalent change in the class of medication change is made, no additional waiting is required before the screening assessments
    5. When a change in class medication change exceeds what is considered stable, OR a new class of medication is added, the screening TTE and CT will be postponed 30 days after the medication change
    6. If an SGLT2 inhibitor is added to a subject's medications, the screening TTE and CT will be postponed at least 30 days after the addition
    7. If an SGLT2 inhibitor dose changes per the stable definition above, no additional waiting is required before the screening assessments
    8. If an SGLT2 inhibitor dose change exceeds what is considered stable, the screening TTE and CT will be postponed at least 30 days after achieving the optimal dose (provided the dose remains outside of the stable parameters)
    9. When applicable, for guideline-directed device-based therapies: a CRT device must be placed > 90 days before the screening TTE and CT, and an ICD must be placed > 30 days before the screening TTE and CT
  7. Able and willing to complete all qualifying diagnostic and functional tests, willing to accept blood product transfusion if required and agrees to comply with study follow-up schedule

Exclusion Criteria:

Cardiovascular

  1. Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 90 days prior to consent
  2. Untreated clinically significant coronary artery disease (CAD) requiring revascularization
  3. Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation
  4. Suboptimal ventricular anatomy or wall thickness as determined from screening echocardiography and/or CT scan
  5. Heart failure on the basis other than ischemic or non-ischemic dilated cardiomyopathy (e.g., hypertrophic cardiomyopathy, amyloid cardiomyopathy, restrictive cardiomyopathy, uncorrected congenital heart disease, constrictive pericarditis)
  6. Hemodynamic instability within 30 days prior to the implant defined as subject requiring inotropic support or mechanical hemodynamic support
  7. Any planned cardiac surgery or interventions within the next 180 days post-randomization (including therapeutic right heart procedures)
  8. Active bacterial endocarditis
  9. Severe RV dysfunction assessed by right heart catheterization (RHC) and/or TTE
  10. Fixed pulmonary hypertension with PA systolic pressure >70 mmHg not responsive to vasodilator therapy

  11. History of any stroke within the prior 90 days of consent or documented Modified Rankin Scale ≥ 2 disability from any prior stroke

    Valvular

  12. Mitral regurgitation grade 3+ (moderate-severe) or 4+ (severe)
  13. Untreated degenerative (primary) mitral valve disease (mild prolapse with no need for intervention is allowable)
  14. Prior mitral or aortic valve replacement
  15. Tricuspid regurgitation grade 4+ (severe)
  16. Moderate or severe aortic valve stenosis (AVA less than 1.5 cm2 or peak velocity AV Vmax >300 cm/sec)

  17. Aortic regurgitation grade 2+ (moderate), 3+ (moderate-severe), or 4+ (severe)

    Procedural

  18. Anatomical pathology or constraints preventing appropriate access/implant of the AccuCinch Ventricular Restoration System (e.g., femoral arteries will not support a 20F Introducer sheath)
  19. Renal insufficiency (i.e., eGFR of <25 ml/min/1.73 m2)
  20. Subjects in whom anticoagulation during the procedure is contraindicated
  21. Subjects in whom 90 days of antiplatelet therapy is contraindicated
  22. Known allergy to nitinol, polyester, or polyethylene

  23. Any prior true anaphylactic reaction to contrast agents; defined as known anaphylactoid or other non-anaphylactic allergic reactions to contrast agents that cannot be adequately pre-medicated prior to the index procedure

    General

  24. Life expectancy <1 year due to non-cardiac conditions
  25. Currently participating in another interventional investigational study
  26. Subjects on high dose steroids or immunosuppressant therapy
  27. Female subjects who are pregnant, of child-bearing potential without a documented birth control method, or who are lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Device group: AccuCinch Ventricular Restoration System
Subjects in this arm will receive the AccuCinch Ventricular Restoration System
Device: AccuCinch Ventricular Restoration System
AccuCinch Ventricular Restoration System
Active Comparator: Control group: Guideline-Directed Medical Therapy
Subjects in this arm will receive guideline-directed medical therapy (GDMT)
Drug: Guideline-Directed Medical Therapy
Guideline-Directed Medical Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from device- or femoral artery access-related major adverse events (MAE)
Time Frame: 180 days

MAE defined as:

  1. All-cause death,
  2. Myocardial infarction,
  3. Stroke,
  4. Need for non-elective cardiovascular surgery,
  5. Worsening of heart-failure requiring mechanical circulatory support for more than 24 hours
  6. Acute kidney injury requiring renal replacement therapy
180 days
Change from baseline in Kansas City Cardiomyopathy Questionnaire Quality of Life Questionnaire (KCCQ) Score
Time Frame: 180 days
Higher scores in the KCCQ reflect better health status
180 days
6-Minute Walk Test (6MWT) distance (m)
Time Frame: 180 days
Change in 6MWT distance (m) from baseline
180 days
Freedom from device- or femoral artery access-related major adverse events (MAE)
Time Frame: 365 days

MAE defined as:

  1. All-cause death,
  2. Myocardial infarction,
  3. Stroke,
  4. Need for non-elective cardiovascular surgery,
  5. Worsening of heart-failure requiring mechanical circulatory support for more than 24 hours
  6. Acute kidney injury requiring renal replacement therapy
365 days
A hierarchical composite endpoint of all-cause deaths, left ventricular assist device (LVAD) implants or heart transplants, heart failure hospitalizations, and changes from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS)
Time Frame: 365 days
A hierarchical composite endpoint of number of all-cause deaths, number of left ventricular assist device (LVAD) implants or heart transplants, number of heart failure hospitalizations, and change from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS), evaluated using the Win Ratio method
365 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of all-cause deaths or all-cause hospitalizations
Time Frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Number of all-cause deaths
Time Frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Number of all-cause hospitalizations
Time Frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Incidence of all serious adverse events, including device- and procedure- related complications
Time Frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Changes from baseline in New York Heart Association (NYHA) functional class
Time Frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Changes from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS)
Time Frame: 30 days, 90 days, 365 days, 545 days, 730 days
Higher scores in the KCCQ reflect better health status
30 days, 90 days, 365 days, 545 days, 730 days
Changes from baseline in 6-Minute Walk Test (6MWT)
Time Frame: 30 days, 90 days, 365 days, 545 days, 730 days
Measure in meters
30 days, 90 days, 365 days, 545 days, 730 days
Changes in left ventricular ejection fraction (LVEF) from baseline and from post-procedure/pre-hospital discharge as assessed by echo
Time Frame: 30 days, 90 days, 365 days, 730 days
30 days, 90 days, 365 days, 730 days
Changes in left ventricular ejection fraction (LVEF) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT
Time Frame: 180 days
180 days
Changes in left ventricular end-diastolic volume (LVEDV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo
Time Frame: 30 days, 90 days, 365 days, 730 days
30 days, 90 days, 365 days, 730 days
Changes in left ventricular end-diastolic volume (LVEDV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT
Time Frame: 180 days
180 days
Changes in left ventricular end-systolic volume (LVESV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo
Time Frame: 30 days, 90 days, 365 days, 730 days
30 days, 90 days, 365 days, 730 days
Changes in left ventricular end-systolic volume (LVESV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT
Time Frame: 180 days
180 days
Rate and number of cardiovascular death events
Time Frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Rate and number of heart failure death events
Time Frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Rate and number of heart failure-related hospitalizations
Time Frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
30 days, 90 days, 180 days, 365 days, 545 days, 730 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline in mitral effective regurgitant orifice area (EROA)
Time Frame: 30 days, 90 days, 180 days, 365 days, 730 days
30 days, 90 days, 180 days, 365 days, 730 days
Changes from baseline in left atrial strain measured by Echo
Time Frame: 30 days, 90 days, 180 days, 365 days, 730 days
30 days, 90 days, 180 days, 365 days, 730 days
Changes from baseline in left ventricular global longitudinal strain measured by Echo
Time Frame: 30 days, 90 days, 180 days, 365 days, 730 days
30 days, 90 days, 180 days, 365 days, 730 days
Changes from baseline in right ventricular free wall longitudinal strain measured by Echo
Time Frame: 30 days, 90 days, 180 days, 365 days, 730 days
30 days, 90 days, 180 days, 365 days, 730 days
Changes from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) individual domains
Time Frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Higher scores in the KCCQ reflect better health status
30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Changes from baseline in EuroQol Five Dimension Five Level (EQ-5D-5L) Quality of Life Questionnaire
Time Frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Lower scores in the EQ-5D-5L reflect better health status
30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Changes from baseline in right ventricular (RV) fractional area change measured by Echo
Time Frame: 30 days, 90 days, 180 days, 365 days, 730 days
Measured by percent change
30 days, 90 days, 180 days, 365 days, 730 days
Changes from baseline in tricuspid annular plane systolic excursion (TAPSE) measured by Echo
Time Frame: 30 days, 90 days, 180 days, 365 days, 730 days
Measured in centimeters or millimeters
30 days, 90 days, 180 days, 365 days, 730 days
Changes from baseline in tricuspid regurgitation measured by Echo
Time Frame: 30 days, 90 days, 180 days, 365 days, 730 days
Measured using effective regurgitant orifice area (mm2) and regurgitant volume (mL)
30 days, 90 days, 180 days, 365 days, 730 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ancora Heart, Inc.

Investigators

  • Study Chair: Martin B Leon, MD, Columbia University
  • Principal Investigator: Ulrich P Jorde, MD, Montefiore Medical Center/Albert Einstein College of Medicine
  • Principal Investigator: Mark Reisman, MD, New York Presbyterian/Weill Cornell Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2020

Primary Completion (Estimated)

June 21, 2024

Study Completion (Estimated)

December 21, 2030

Study Registration Dates

First Submitted

March 30, 2020

First Submitted That Met QC Criteria

April 1, 2020

First Posted (Actual)

April 2, 2020

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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