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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04198870
Other study ID # ABT-CIP-10304
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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