MitraClip REPAIR MR Study

December 14, 2023 updated by: Abbott Medical Devices

Percutaneous MitraClip Device or Surgical Mitral Valve REpair in PAtients With PrImaRy MItral Regurgitation Who Are Candidates for Surgery (REPAIR MR)

The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

500

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

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • Withdrawn
        • Ottawa Heart Institute
      • Toronto, Ontario, Canada, M5B 1W8
        • Recruiting
        • St. Michael's Hospital
        • Contact:
        • Sub-Investigator:
          • David Latter, MD
        • Principal Investigator:
          • Neil Fam, MD
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • Toronto General Hospital
        • Contact:
        • Sub-Investigator:
          • Mitesh Badiwala, MD
        • Principal Investigator:
          • Eric Horlick, MD
      • Toronto, Ontario, Canada, M5N 3M5
        • Recruiting
        • Sunnybrook Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Andrew Czarnecki, MD
        • Sub-Investigator:
          • Gideon Cohen, MD
    • Quebec
      • Montréal, Quebec, Canada, H1T 1C8
        • Recruiting
        • Institut de Cardiologie de Montreal (Montreal Heart Inst.)
        • Contact:
        • Principal Investigator:
          • Anita Asgar, MD
        • Sub-Investigator:
          • Michel Pellerin, MD
  • Germany
      • München, Germany, 80636
        • Recruiting
        • Deutsches Herzzentrum München des Freistaates Bayern
        • Contact:
        • Principal Investigator:
          • Erion Xhepa
        • Sub-Investigator:
          • Keti Vitanova
      • Rostock, Germany, 18057
        • Recruiting
        • Universitätsklinikum Rostock (AöR)
        • Contact:
        • Principal Investigator:
          • Hueseyin Ince, MD
        • Sub-Investigator:
          • Alper Oener, MD
    • Bad-wur
      • Ulm, Bad-wur, Germany, 89081
        • Recruiting
        • Universitätsklinikum Ulm
        • Principal Investigator:
          • Wolfgang Rottbauer, MD
        • Contact:
        • Sub-Investigator:
          • Andreas Leibold, MD
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60590
        • Recruiting
        • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
        • Contact:
        • Principal Investigator:
          • Thomas Walther, Prof.Dr.med.
    • North Rhine-Westphalia
      • Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545
        • Recruiting
        • Herz-und Diabetes Zentrum NRW
        • Contact:
        • Sub-Investigator:
          • Jan Gummert, MD
        • Principal Investigator:
          • Volker Rudolph, MD
    • Rhinela
      • Mainz, Rhinela, Germany, 55131
        • Recruiting
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
        • Principal Investigator:
          • Ralph Stephan von Bardeleben
        • Contact:
          • Ralph Stephan von Bardeleben
    • Saxony
      • Leipzig, Saxony, Germany, 04289
        • Withdrawn
        • Herzzentrum Leipzig GmbH
  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • Center Inselspital Bern
        • Principal Investigator:
          • Matthias Siepe, MD
        • Sub-Investigator:
          • Fabien Praz, MD
        • Contact:
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • Recruiting
        • University Hospital - Univiversity of Alabama at Birmingham
        • Contact:
        • Sub-Investigator:
          • Clifton Lewis, MD
        • Principal Investigator:
          • Mustafa Ahmed, MD
      • Mobile, Alabama, United States, 36608
        • Recruiting
        • Cardiology Associates of Mobile, Inc.
        • Contact:
        • Principal Investigator:
          • Mir Wail Hashimi, MD
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Banner-University Medical Center Phoenix
        • Contact:
        • Principal Investigator:
          • Divya Verma, MD
        • Sub-Investigator:
          • Kenith Fang, MD
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Arizona Cardiovascular Research Center
        • Contact:
        • Sub-Investigator:
          • Kevin Brady, MD
        • Principal Investigator:
          • Hursh Naik, MD
      • Phoenix, Arizona, United States, 85013
        • Not yet recruiting
        • St. Joseph's Hospital & Medical Center
        • Sub-Investigator:
          • Kevin Brady, MD
        • Contact:
        • Principal Investigator:
          • Naik Hursh, MD
      • Tucson, Arizona, United States, 85712
        • Recruiting
        • Tucson Medical Center
        • Contact:
        • Sub-Investigator:
          • Raj Bose, MD
        • Principal Investigator:
          • Thomas Waggoner, MD
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • Scripps Memorial Hospital La Jolla
        • Contact:
        • Principal Investigator:
          • Matthew Price, MD
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Principal Investigator:
          • Raj Makkar
        • Contact:
        • Sub-Investigator:
          • Alfredo Trento
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis Medical Center
        • Principal Investigator:
          • Bob Kiaii
      • Sacramento, California, United States, 95819
        • Recruiting
        • Mercy General Hospital
        • Contact:
        • Principal Investigator:
          • Kapil Sharma, MD
        • Sub-Investigator:
          • Joseph Kozina, MD
      • Sacramento, California, United States, 95816
        • Recruiting
        • Sutter Medical Center, Sacramento
        • Contact:
        • Principal Investigator:
          • David Roberts, MD
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California at San Francisco
        • Contact:
        • Principal Investigator:
          • Richard Cheng, MD
        • Sub-Investigator:
          • Tom C Nguyen, MD
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University Medical Center
        • Contact:
        • Principal Investigator:
          • John MacArthur, MD
        • Sub-Investigator:
          • Rahul Sharma, MD
      • Thousand Oaks, California, United States, 91360
        • Recruiting
        • Los Robles Regional Medical Center
        • Sub-Investigator:
          • Greg Fontana, MD
        • Contact:
        • Principal Investigator:
          • Saibal Kar, MD
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Saint Joseph Hospital
        • Principal Investigator:
          • Jake Chanin, MD
        • Contact:
        • Sub-Investigator:
          • Fredrico Milla, MD
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale New Haven Hospital
        • Principal Investigator:
          • John Forrest
        • Contact:
          • Ryan Kaple
    • Florida
      • Bradenton, Florida, United States, 34208
        • Withdrawn
        • Manatee Memorial Hospital
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist Medical Center
        • Contact:
        • Principal Investigator:
          • Ruby Satpathy, MD
        • Sub-Investigator:
          • Siddharth Wayangankar, MD
      • Naples, Florida, United States, 34102
        • Recruiting
        • NCH Healthcare System
        • Principal Investigator:
          • Roberto Cubeddu, MD
        • Sub-Investigator:
          • Brian Solomon, MD
        • Contact:
      • Orlando, Florida, United States, 33019
        • Withdrawn
        • AdventHealth Orlando
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Heart Institute
        • Principal Investigator:
          • Vivek Rajagopal, MD
        • Contact:
        • Sub-Investigator:
          • Vinod Thourani, MD
      • Marietta, Georgia, United States, 30060
        • Withdrawn
        • Wellstar Kennestone Hospital
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Memorial Hospital
        • Contact:
        • Sub-Investigator:
          • Patrick McCarthy, MD
        • Principal Investigator:
          • Charles Davidson, MD
      • Springfield, Illinois, United States, 62701
        • Recruiting
        • Prairie Education & Research Cooperative
        • Contact:
        • Sub-Investigator:
          • Jeff Christy, MD
        • Principal Investigator:
          • Jeffrey Goldstein, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46240
        • Recruiting
        • St. Vincent Hospital
        • Principal Investigator:
          • James Hermiller, MD
        • Sub-Investigator:
          • David Heimansohn, MD
        • Contact:
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • Kansas University Medical Center
        • Contact:
        • Sub-Investigator:
          • Peter Tadros, MD
        • Principal Investigator:
          • Emmanuel Daon, MD
      • Wichita, Kansas, United States, 67226
        • Recruiting
        • Cardiovascular Research Institute of Kansas
        • Contact:
        • Principal Investigator:
          • Bassem Chehab, MD
        • Sub-Investigator:
          • Brett Grizzell, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Sub-Investigator:
          • Serguei Melnitchouk, MD
        • Principal Investigator:
          • Rahul Sakhuja, MD
        • Contact:
      • Boston, Massachusetts, United States, 02115
        • Active, not recruiting
        • Brigham & Women's Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Recruiting
        • University of Michigan
        • Sub-Investigator:
          • Stanley Chetcuti, MD
        • Principal Investigator:
          • Steven Bolling, MD
        • Contact:
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Principal Investigator:
          • Brian Brian O'Neill, MD
        • Sub-Investigator:
          • Hassan Nemeh, MD
        • Contact:
      • Royal Oak, Michigan, United States, 48073
        • Recruiting
        • Beaumont Hospital, Royal Oak
        • Principal Investigator:
          • Ivan Hanson, MD
        • Contact:
        • Sub-Investigator:
          • Bogdan Kindzelski, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Abbott Northwestern Hospital
        • Principal Investigator:
          • Paul Sorajja, MD
        • Contact:
        • Sub-Investigator:
          • Benjamin Sun, MD
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Recruiting
        • Cooper University Hospital
        • Contact:
        • Principal Investigator:
          • Sajjad Sabir, MD
      • Morristown, New Jersey, United States, 07962
        • Recruiting
        • Atlantic Health System - Morristown Memorial Hospital
        • Sub-Investigator:
          • John Brown III, MD
        • Principal Investigator:
          • Philippe Genereux, MD
        • Contact:
      • Neptune, New Jersey, United States, 07753
        • Recruiting
        • Jersey Shore University Medical Center
        • Contact:
        • Principal Investigator:
          • Matthew Saybolt, MD
      • New Brunswick, New Jersey, United States, 08901
        • Withdrawn
        • Robert Wood Johnson University Hospital
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Albany Medical Center
        • Contact:
        • Principal Investigator:
          • Sanjay A Samy, MD
        • Sub-Investigator:
          • Augustin J Delago, MD
      • Bay Shore, New York, United States, 11706
        • Recruiting
        • Southside Hospital - Northwell Health
        • Contact:
        • Principal Investigator:
          • Robert Kalimi, MD
        • Sub-Investigator:
          • Lawrence Ong, MD
      • Buffalo, New York, United States, 14203
        • Withdrawn
        • Buffalo General Hospital
      • New York, New York, United States, 10016
      • New York, New York, United States, 10032
        • Recruiting
        • New York-Presbyterian/Columbia University Medical Center
        • Contact:
        • Sub-Investigator:
          • Isaac George, MD
        • Principal Investigator:
          • Susheel Kodali, MD
      • Rochester, New York, United States, 14617
        • Recruiting
        • Rochester Regional Health
        • Sub-Investigator:
          • Sunil M Prasad, MD
        • Principal Investigator:
          • Jeremiah Depta, MD
        • Contact:
      • Roslyn, New York, United States, 11576
        • Recruiting
        • St. Francis Hospital
        • Contact:
        • Sub-Investigator:
          • Newell Robinson, MD
        • Principal Investigator:
          • George Petrossian, MD
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Recruiting
        • Mission Health & Hospitals
        • Contact:
        • Principal Investigator:
          • Michael Chenier, MD
        • Sub-Investigator:
          • Mark Groh, MD
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Carolinas Medical Center
        • Principal Investigator:
          • Michael Rinaldi, MD
        • Contact:
        • Sub-Investigator:
          • Eric Skipper, MD
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke University Medical Center
        • Contact:
        • Sub-Investigator:
          • Donald Glower, MD
        • Principal Investigator:
          • Andrew Wang, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • Christ Hospital
        • Principal Investigator:
          • Santiago Garcia, MD
        • Contact:
        • Sub-Investigator:
          • John M Smith, MD
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center
        • Contact:
        • Sub-Investigator:
          • Marc Pelletier, MD
        • Principal Investigator:
          • Guilherme Attizzani, MD
      • Cleveland, Ohio, United States, 44195
        • Withdrawn
        • The Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43213
        • Recruiting
        • Mt. Carmel East
        • Sub-Investigator:
          • Michael Gibson, MD
        • Contact:
        • Principal Investigator:
          • Noah Jones, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Recruiting
        • Integris Baptist Medical Center
        • Contact:
          • Craig Elkins
        • Principal Investigator:
          • Craig Elkins
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17105
        • Recruiting
        • Pinnacle Health System
        • Contact:
        • Principal Investigator:
          • Mubashir Mumtaz, MD
        • Sub-Investigator:
          • Hemal Gada, MD
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh Medical Center
        • Contact:
        • Principal Investigator:
          • Ibrahim Sultan
        • Sub-Investigator:
          • Saurabh Sanon
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny General Hospital - ASRI
        • Contact:
        • Principal Investigator:
          • Walter McGregor, MD
      • Wynnewood, Pennsylvania, United States, 19096
        • Recruiting
        • Lankenau Institute for Medical Research
        • Contact:
        • Principal Investigator:
          • Scott Goldman, MD
        • Sub-Investigator:
          • William Gray, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Centennial Medical Center
        • Contact:
        • Sub-Investigator:
          • Samuel Horr, MD
        • Principal Investigator:
          • Sreekumar Subramanian, MD
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt Heart & Vascular Institute
        • Contact:
        • Sub-Investigator:
          • Ashish Shah, MD
        • Principal Investigator:
          • Colin Barker, MD
      • Nashville, Tennessee, United States, 37205
        • Recruiting
        • St Thomas Hospital
        • Contact:
        • Principal Investigator:
          • Evelio Rodriguez
        • Sub-Investigator:
          • Andrew Morse
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Ascension Texas Cardiovascular
        • Contact:
        • Principal Investigator:
          • Mark Pirwitz, MD
        • Sub-Investigator:
          • George Arnaoutakis, MD
      • Austin, Texas, United States, 78756
        • Withdrawn
        • Austin Heart
      • Houston, Texas, United States, 77030
        • Recruiting
        • The Methodist Hospital
        • Principal Investigator:
          • Sachin Goel, MD
        • Contact:
        • Sub-Investigator:
          • Gerald Lawrie, MD
      • Houston, Texas, United States, 77004
        • Recruiting
        • Park Plaza Hospital/HCA Hospital of Houston
        • Sub-Investigator:
          • Keshava Rajagopal, MD
        • Contact:
        • Principal Investigator:
          • Pranav Loyalka, MD
      • Houston, Texas, United States, 77008
        • Recruiting
        • Memorial Hermann Hospital
        • Sub-Investigator:
          • Tom Nguyen, MD
        • Principal Investigator:
          • Richard Smalling, MD
        • Contact:
      • Plano, Texas, United States, 75093
        • Withdrawn
        • The Heart Hospital Baylor Plano
    • Utah
      • Murray, Utah, United States, 84157
        • Recruiting
        • Intermountain Medical Center
        • Contact:
        • Principal Investigator:
          • Brian Whisenant, MD
        • Sub-Investigator:
          • Stephen Clayson, MD
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia Medical Center
        • Contact:
        • Principal Investigator:
          • Scott Lim, MD
        • Sub-Investigator:
          • Gorav Ailawadi, MD
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Sentara Norfolk General Hospital
        • Principal Investigator:
          • Matthew Summers, MD
        • Contact:
        • Sub-Investigator:
          • Clinton Kemp, MD
    • Washington
      • Seattle, Washington, United States, 98107
        • Recruiting
        • Swedish Medical Center
        • Contact:
        • Sub-Investigator:
          • Ming Zhang, MD
        • Principal Investigator:
          • Sameer Gafoor, MD
      • Seattle, Washington, United States, 98111
        • Recruiting
        • The Heart Institute at Virginia Mason
        • Contact:
        • Principal Investigator:
          • Ming Zhang, MD
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Active, not recruiting
        • West Virginia University Hospital

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. Subject has severe (Grade III or greater per the ASE criteria, which includes severity grades of 3+ and 4+) primary MR (mixed etiology is acceptable provided the principal mechanism of action is a degenerative mitral valve) as assessed by the ECL.
  2. The cardiac surgeon of the Site Heart Team (consisting of at least one interventionalist, and one cardiac surgeon) has confirmed that the subject is a candidate for mitral valve surgery and the EC have confirmed that the subject's mitral valve anatomy is suitable for percutaneous repair with the MitraClip™ device with high certainty of achieving MR ≤ mild
  3. Subject is symptomatic (NYHA Class II/III/IV) or asymptomatic with LVEF ≤ 60%, pulmonary artery systolic pressure > 50 mmHg, or LVESD > 40 mm

  4. Subject is at moderate surgical risk defined as being at least 75 years of age at the time of EC review. If younger than 75 years, then the subject should have:

    1. Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) Repair Score ≥ 2%, OR
    2. Presence of other comorbidities which may introduce a potential surgery-specific impediment
  5. Subject provides written informed consent
  6. Subject is ≥ 18 years of age

Exclusion Criteria:

  1. Subject is currently participating in another clinical investigation
  2. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
  3. Subject has ischemic or non-ischemic secondary MR
  4. Concomitant severe tricuspid valve regurgitation
  5. Ejection fraction <30%
  6. Severe mitral annular calcification
  7. Acute myocardial infarction in the past 12 weeks
  8. Need for cardiac surgery to correct pulmonary valve disease, aortic valve disease, or tricuspid valve disease
  9. Subjects who have concurrent coronary artery disease that needs to be treated may be included provided the subjects are eligible for both percutaneous coronary intervention (PCI) and coronary artery bypass surgery. Subjects randomized to the device group, must undergo PCI before the MitraClip™ device procedure. Subjects randomized to the surgical (control) arm may undergo coronary artery revascularization during mitral valve repair surgery
  10. Surgical procedure performed in the past 30 days
  11. Femoral vein cannot accommodate a 24 F catheter or presence of IVC filter would interfere with the catheter or ipsilateral DVT
  12. Transesophageal echocardiography (TEE) is contraindicated.
  13. Hemodynamic instability: systolic pressure ≤ 90 mmHg without afterload reduction, cardiogenic shock, or the need for inotropic support or IABP
  14. Need for emergency surgery for any reason
  15. Prior mitral valve surgery, valvuloplasty, mechanical prosthetic valve or VAD
  16. Systolic anterior motion of the mitral valve
  17. Hypertrophic cardiomyopathy
  18. Renal insufficiency requiring dialysis
  19. Active infections requiring current antibiotic therapy

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control Arm
Mitral Valve Repair Surgery
Procedure: Mitral Valve Repair Surgery
Surgical repair of the mitral valve
Experimental: Device Arm
MitraClip™ device implantation
Device: MitraClip™ device implantation
Transcatheter repair of the mitral valve using MitraClip™ device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality, stroke, cardiac hospitalization, or acute kidney injury requiring renal replacement therapy at 2 years (any cardiac hospitalizations in the first 30 days post treatment will be excluded)
Time Frame: 2 Years
The proportion of subjects who are alive, without stroke, CV hospitalization or acute kidney injury requiring renal replacement therapy at 2 years in the Device and Control groups, respectively
2 Years
Proportion of subjects with moderate or less MR (≤2+), without mitral valve replacement, and without recurrent mitral valve intervention (surgical or percutaneous)
Time Frame: 2 Years
Proportion of subjects with moderate or less MR (≤2+), without mitral valve replacement, and without recurrent mitral valve intervention (surgical or percutaneous) from the time of index procedure through 2 years in the Device and Control groups, respectively
2 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects with MR ≤ mild at 30 days post index procedure among survivors
Time Frame: 30 Days
The proportion of subjects with MR ≤ mild at 30 days post index procedure among survivors will be compared between the Device and Control groups
30 Days
Number of days at hospital from index procedure to home discharge
Time Frame: At Discharge (≤ 14 days following index procedure)
Hospital length of stay from index procedure to home discharge (days) in Device group compared to the Control group
At Discharge (≤ 14 days following index procedure)
Proportion of subjects discharged to home post index hospitalization
Time Frame: At Discharge (≤ 14 days following index procedure)
The proportion of subjects who are discharged to home post index hospitalization will be compared between the Device and Control groups
At Discharge (≤ 14 days following index procedure)
Quality of life improvement assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) of at least 10 points at 2 years compared to baseline among survivors.
Time Frame: 2 Years

The proportion of subjects who have at least a 10 point improvement in KCCQ at 2 years post index procedure from baseline among survivors will be compared between the Device and Control groups for non-inferiority.

The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered questionnaire used for quantifying patient's health status including the symptoms (frequency and burden), physical and social limitations, and quality of life impact due to the heart failure syndrome. Validity, reproducibility, responsiveness and interpretability of the scores have been independently established for each of these health status domains, and overall summary scores are reported in a range of 0-100, in which higher scores reflect better health status.
2 Years
Severe symptomatic mitral stenosis at 1 year
Time Frame: 1 Year
The proportion of subjects who have severe symptomatic mitral stenosis at 1 year post index procedure will be compared between the Device and Control groups
1 Year

Collaborators and Investigators

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

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Saibal Kar, MD, Los Robles Regional Medical Center
  • Study Director: Erin Spinner, PhD, Abbott Structural Heart
  • Principal Investigator: Patrick McCarthy, MD, Northwestern Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 21, 2020

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2034

Study Registration Dates

First Submitted

December 11, 2019

First Submitted That Met QC Criteria

December 12, 2019

First Posted (Actual)

December 13, 2019

Study Record Updates

Last Update Posted (Actual)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABT-CIP-10304

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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