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

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: Suspended
• Conditions: Dilated Cardiomyopathy; Heart Failure With Reduced Ejection Fraction (HFrEF)
• Intervention / Treatment: Device: AccuCinch Ventricular Restoration System; Drug: Guideline-Directed Medical Therapy

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

Study Locations

• Belarus
  • Minsk, Belarus, 220036
    • Republican Scientific and Practical Centre of Cardiology
• Belgium
  • Aalst, Belgium, 9300
    • OLV Heart Centre
  • Bruges, Belgium
    • AZ Sint-Jan-Oostende AV Campus Brugge
• Czechia
  • Brno, Czechia, 60200
    • St. Anne's University Hospital
  • Prague, Czechia
    • Na Homolce Hospital
• France
  • Marseille, France, 13005
    • Hôpital de La Timone
  • Rennes, France, 35033
    • CHU de Rennes - Hôpital Pontchaillou
  • Toulouse, France, 31300
    • Clinique-Pasteur
• Germany
  • Bernau, Germany, 16321
    • Immanuel Klinikum Bernau Herzzentrum Brandenburg Universitätsklinikum der Medizinischen Hochschule Brandenburg
  • Cologne, Germany, 50937
    • Universitätsklinikum Köln (AöR)
  • Frankfurt, Germany, 60389
    • CardioVasculäres Centrum
  • Halle, Germany, 06120
    • Universitatsklinikum Halle (Saale)
  • Hamburg, Germany, 20246
    • Universitäres Herz- und Gefäßzentrum Hamburg
• Greece
  • Athens, Greece
    • Hygeia Hospital
  • Kallithea, Greece, 17674
    • Onassis Cardiac Surgery Center
  • Thessaloniki, Greece, 57001
    • Interbalkan Medical Hospital of Thessaloniki
• Italy
  • Milan, Italy, 20138
    • Centro Cardiologico Monzino S.p.a
  • Catania
    • Catania, Catania, Italy, 95123
      • A O U Policlinico G. Rodolico - San Marco
  • Lombardy
    • Milan, Lombardy, Italy, 20089
      • Irccs Istituto Clinico Humanitas
  • Torino
    • Torino, Torino, Italy, 10126
      • AOU Città della salute e della Scienza - Ospedale Molinette
• Netherlands
  • Nieuwegein, Netherlands
    • St. Antonius Ziekenhuis
  • Rotterdam, Netherlands
    • Erasmus Medical Center
• Serbia
  • Belgrade, Serbia, 11000
    • University Clinical Centre of Serbia
  • Belgrade, Serbia, 11000
    • Institute of Cardiovascular Diseases of Vojvodina
  • Belgrade, Serbia, 11000
    • Institute of Cardiovascular Diseases
  • Niš, Serbia, 18108
    • University Clinical Center Nis
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Grandview Medical Group Research, LLC
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Dignity Health St. Joseph's Hospital and Medical Center
    • Phoenix, Arizona, United States, 85016
      • Phoenix Cardiovascular Research Group
    • Tucson, Arizona, United States, 85712
      • Tucson Medical Center
  • California
    • La Jolla, California, United States, 92037
      • University of California San Diego
    • La Jolla, California, United States, 92121
      • Scripps Health
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • Orange, California, United States, 92868
      • University of California Irvine Medical Center
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
    • San Francisco, California, United States, 94115
      • Kaiser Permanente San Francisco
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Health
    • New Haven, Connecticut, United States, 06519
      • Yale University
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Medstar Health Research Institute
  • Florida
    • Atlantis, Florida, United States, 33462
      • JFK Medical Center
    • Largo, Florida, United States, 33770
      • HCA Florida Largo Hospital
    • Miami, Florida, United States, 33136
      • University of Miami
    • Pensacola, Florida, United States, 32504
      • Ascension Sacred Heart
    • Tampa, Florida, United States, 33606
      • University of South Florida
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University
    • Atlanta, Georgia, United States, 30342
      • Northside Hospital
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
    • Downers Grove, Illinois, United States, 60515
      • Advocate Good Samaritan Hospital
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
    • Wichita, Kansas, United States, 67226
      • Cardiovascular Research Institute of Kansas
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky
    • Louisville, Kentucky, United States, 40216
      • Norton Heart Specialists
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Our Lady of the Lake Regional Medical Center
    • Houma, Louisiana, United States, 70360
      • Cardiovascular Institute of the South
  • Maine
    • Bangor, Maine, United States, 04401
      • Northern Light Eastern Maine Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
    • Southfield, Michigan, United States, 48075
      • Ascension Providence Hospital
  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433
      • Metropolitan Heart and Vascular Institute & Mercy Hosp
    • Minneapolis, Minnesota, United States, 55414
      • University of Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute Foundation
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Jackson Heart Clinic
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University in St. Louis
  • New Jersey
    • Browns Mills, New Jersey, United States, 08015
      • Deborah Heart & Lung
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
    • New Brunswick, New Jersey, United States, 08903
      • Rutgers Robert Wood Johnson Medical School
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • New Mexico Heart Institute
  • New York
    • Buffalo, New York, United States, 14203
      • University at Buffalo
    • Manhasset, New York, United States, 11030
      • Northwell Health
    • New York, New York, United States, 10016
      • NYU Langone Health
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
    • New York, New York, United States, 10065
      • Weill Cornell Medicine-New York Presbyterian Hospital
    • New York, New York, United States, 10032
      • CUMC/New York Presbyterian Hospital
    • Poughkeepsie, New York, United States, 12601
      • Vassar Brothers Medical Center
    • Roslyn, New York, United States, 11576
      • St. Francis Hospital
    • The Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill
    • Raleigh, North Carolina, United States, 27607
      • NC Heart and Vascular Research, LLC
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Oklahoma Heart Hospital
    • Oklahoma City, Oklahoma, United States, 73112
      • Integris Baptist Medical Center
    • Tulsa, Oklahoma, United States, 74104
      • Oklahoma Heart Institute
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
    • Portland, Oregon, United States, 97225
      • Providence St. Vincent Medical Center
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Clinic
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Heart and Vascular Institute
  • Rhode Island
    • Providence, Rhode Island, United States, 02904
      • Rhode Island Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Columbia, South Carolina, United States, 29203
      • Prisma Health
  • Tennessee
    • Knoxville, Tennessee, United States, 37934
      • Tennova Healthcare-Turkey Creek Medical Center
    • Nashville, Tennessee, United States, 37221
      • Ascension Saint Thomas
    • Nashville, Tennessee, United States, 87232
      • Vanderbilt University Medical Center
  • Texas
    • Austin, Texas, United States, 78756
      • Austin Heart
    • Austin, Texas, United States, 78705
      • Ascension Texas Cardiovascular
    • Dallas, Texas, United States, 75226
      • Baylor Scott & White Research Institute
    • Houston, Texas, United States, 77030
      • UT Health
    • Houston, Texas, United States, 77020
      • Baylor College of Medicine St. Luke's Medical Center
    • Houston, Texas, United States, 77004
      • Houston Heart
    • Plano, Texas, United States, 75093
      • Baylor Scott & White
    • San Antonio, Texas, United States, 78229
      • Methodist Healthcare System, San Antonio
  • Utah
    • Salt Lake City, Utah, United States, 84109
      • Intermountain Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
    • Richmond, Virginia, United States, 23225
      • CJW Chippenham Medical Center
    • Richmond, Virginia, United States, 23226
      • Bon Secours St Mary's Hospital
    • Roanoke, Virginia, United States, 24014
      • Carilion Roanoke Memorial Hospital
    • Winchester, Virginia, United States, 22601
      • Valley Health Winchester
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington
    • Spokane, Washington, United States, 99204
      • Providence Sacred Heart Medical Center
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • Charleston Area Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora St. Luke's Medical Center

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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)	MAE defined as: All-cause death,; Myocardial infarction,; Stroke,; Need for non-elective cardiovascular surgery,; Worsening of heart-failure requiring mechanical circulatory support for more than 24 hours; Acute kidney injury requiring renal replacement therapy	180 days
Change from baseline in Kansas City Cardiomyopathy Questionnaire Quality of Life Questionnaire (KCCQ) Score	Higher scores in the KCCQ reflect better health status	180 days
6-Minute Walk Test (6MWT) distance (m)	Change in 6MWT distance (m) from baseline	180 days
Freedom from device- or femoral artery access-related major adverse events (MAE)	MAE defined as: All-cause death,; Myocardial infarction,; Stroke,; Need for non-elective cardiovascular surgery,; Worsening of heart-failure requiring mechanical circulatory support for more than 24 hours; 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)	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		30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Number of all-cause deaths		30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Number of all-cause hospitalizations		30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Incidence of all serious adverse events, including device- and procedure- related complications		30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Changes from baseline in New York Heart Association (NYHA) functional class		30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Changes from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS)	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)	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		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		180 days
Changes in left ventricular end-diastolic volume (LVEDV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo		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		180 days
Changes in left ventricular end-systolic volume (LVESV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo		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		180 days
Rate and number of cardiovascular death events		30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Rate and number of heart failure death events		30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Rate and number of heart failure-related hospitalizations		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)		30 days, 90 days, 180 days, 365 days, 730 days
Changes from baseline in left atrial strain measured by Echo		30 days, 90 days, 180 days, 365 days, 730 days
Changes from baseline in left ventricular global longitudinal strain measured by Echo		30 days, 90 days, 180 days, 365 days, 730 days
Changes from baseline in right ventricular free wall longitudinal strain measured by Echo		30 days, 90 days, 180 days, 365 days, 730 days
Changes from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) individual domains	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	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	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	Measured in centimeters or millimeters	30 days, 90 days, 180 days, 365 days, 730 days
Changes from baseline in tricuspid regurgitation measured by Echo	Measured using effective regurgitant orifice area (mm2) and regurgitant volume (mL)	30 days, 90 days, 180 days, 365 days, 730 days

Collaborators and Investigators

• 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: Shmuel Chen, MD, New York Presbyterian/Weill Cornell Medicine

Publications and helpful links

General Publications

• Hamid N, Jorde UP, Reisman M, Latib A, Lim DS, Joseph SM, Kurlianskaya A, Polonetsky O, Neuzil P, Reddy V, Foerst J, Gada H, Grubb KJ, Silva G, Kereiakes D, Shreenivas S, Pinney S, Davidavicius G, Sorajja P, Boehmer JP, Kleber FX, Perier P, VAN Mieghem NM, Dumonteil N, Leon MB, Burkhoff D. Transcatheter Left Ventricular Restoration in Patients With Heart Failure. J Card Fail. 2023 Jul;29(7):1046-1055. doi: 10.1016/j.cardfail.2023.03.003. Epub 2023 Mar 22.

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2020
• Primary Completion (Estimated): December 31, 2026
• 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): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Heart Failure; Cardiomyopathy; Reduced Ejection Fraction
• Additional Relevant MeSH Terms: Laminopathies; Cardiovascular Diseases; Heart Diseases; Genetic Diseases, Inborn; Cardiomegaly; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Failure; Cardiomyopathies; Cardiomyopathy, Dilated
• 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
• product manufactured in and exported from the U.S.: No