MitraClip REPAIR MR Study

Mitral Valve Regurgitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04198870
• Other study ID #: ABT-CIP-10304
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2020
• Est. completion date: April 2034

Study information

• Verified date: December 2023
• Source: Abbott Medical Devices
• Contact: Janna Joyner
• Phone: +1 919 971 4537
• Email: janna.joyner[@]abbott.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 2034
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mitral Valve Insufficiency
• Mitral Valve Regurgitation

Intervention

Device:
• MitraClip™ device implantation
Transcatheter repair of the mitral valve using MitraClip™ device

Procedure:
• Mitral Valve Repair Surgery
Surgical repair of the mitral valve

Locations

Country	Name	City	State
Canada	Institut de Cardiologie de Montreal (Montreal Heart Inst.)	Montréal	Quebec
Canada	Ottawa Heart Institute	Ottawa	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
Germany	Herz-und Diabetes Zentrum NRW	Bad Oeynhausen	North Rhine-Westphalia
Germany	Klinikum der Johann Wolfgang Goethe-Universität Frankfurt	Frankfurt am Main	Hessen
Germany	Herzzentrum Leipzig GmbH	Leipzig	Saxony
Germany	Universitätsmedizin der Johannes Gutenberg-Universität Mainz	Mainz	Rhinela
Germany	Deutsches Herzzentrum München des Freistaates Bayern	München
Germany	Universitätsklinikum Rostock (AöR)	Rostock
Germany	Universitätsklinikum Ulm	Ulm	Bad-wur
Switzerland	Center Inselspital Bern	Bern
United States	Albany Medical Center	Albany	New York
United States	University of Michigan	Ann Arbor	Michigan
United States	Mission Health & Hospitals	Asheville	North Carolina
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	Ascension Texas Cardiovascular	Austin	Texas
United States	Austin Heart	Austin	Texas
United States	Southside Hospital - Northwell Health	Bay Shore	New York
United States	University Hospital - Univiversity of Alabama at Birmingham	Birmingham	Alabama
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Manatee Memorial Hospital	Bradenton	Florida
United States	Buffalo General Hospital	Buffalo	New York
United States	Cooper University Hospital	Camden	New Jersey
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Christ Hospital	Cincinnati	Ohio
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Mt. Carmel East	Columbus	Ohio
United States	Saint Joseph Hospital	Denver	Colorado
United States	Henry Ford Hospital	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Pinnacle Health System	Harrisburg	Pennsylvania
United States	Memorial Hermann Hospital	Houston	Texas
United States	Park Plaza Hospital/HCA Hospital of Houston	Houston	Texas
United States	The Methodist Hospital	Houston	Texas
United States	St. Vincent Hospital	Indianapolis	Indiana
United States	Baptist Medical Center	Jacksonville	Florida
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Scripps Memorial Hospital La Jolla	La Jolla	California
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	WellStar Kennestone Hospital	Marietta	Georgia
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	Cardiology Associates of Mobile, Inc.	Mobile	Alabama
United States	West Virginia University Hospital	Morgantown	West Virginia
United States	Atlantic Health System - Morristown Memorial Hospital	Morristown	New Jersey
United States	Intermountain Medical Center	Murray	Utah
United States	NCH Healthcare System	Naples	Florida
United States	Centennial Medical Center	Nashville	Tennessee
United States	St Thomas Hospital	Nashville	Tennessee
United States	Vanderbilt Heart & Vascular Institute	Nashville	Tennessee
United States	Jersey Shore University Medical Center	Neptune	New Jersey
United States	Robert Wood Johnson University Hospital	New Brunswick	New Jersey
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	New York-Presbyterian/Columbia University Medical Center	New York	New York
United States	NYU Langone Medical Center	New York	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Integris Baptist Medical Center	Oklahoma City	Oklahoma
United States	AdventHealth Orlando	Orlando	Florida
United States	Arizona Cardiovascular Research Center	Phoenix	Arizona
United States	Banner-University Medical Center Phoenix	Phoenix	Arizona
United States	St. Joseph's Hospital & Medical Center	Phoenix	Arizona
United States	Allegheny General Hospital - ASRI	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	Rochester Regional Health	Rochester	New York
United States	St. Francis Hospital	Roslyn	New York
United States	Beaumont Hospital, Royal Oak	Royal Oak	Michigan
United States	Mercy General Hospital	Sacramento	California
United States	Sutter Medical Center, Sacramento	Sacramento	California
United States	UC Davis Medical Center	Sacramento	California
United States	University of California at San Francisco	San Francisco	California
United States	Swedish Medical Center	Seattle	Washington
United States	The Heart Institute at Virginia Mason	Seattle	Washington
United States	Prairie Education & Research Cooperative	Springfield	Illinois
United States	Stanford University Medical Center	Stanford	California
United States	Los Robles Regional Medical Center	Thousand Oaks	California
United States	Tucson Medical Center	Tucson	Arizona
United States	Cardiovascular Research Institute of Kansas	Wichita	Kansas
United States	Lankenau Institute for Medical Research	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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
Primary	Proportion of subjects with moderate or less MR (=2+), without mitral valve replacement, and without recurrent mitral valve intervention (surgical or percutaneous)	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	Proportion of subjects with MR = mild at 30 days post index procedure among survivors	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
Secondary	Number of days at hospital from index procedure to home discharge	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)
Secondary	Proportion of subjects discharged to home post index hospitalization	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)
Secondary	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.	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
Secondary	Severe symptomatic mitral stenosis at 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