Clinical trial NCT04198870: MitraClip REPAIR MR Study
Official title: Percutaneous MitraClip Device or Surgical Mitral Valve REpair in PAtients With PrImaRy MItral Regurgitation Who Are Candidates for Surgery (REPAIR MR)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mitral Valve Regurgitation
Keywords: MitraClip
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2019-12-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 2 Years
measure: Proportion of subjects with moderate or less MR (≤2+), without mitral valve replacement, and without recurrent mitral valve intervention (surgical or percutaneous)
timeFrame: 2 Years
Secondary outcomes:
measure: Proportion of subjects with MR ≤ mild at 30 days post index procedure among survivors
timeFrame: 30 Days
measure: Number of days at hospital from index procedure to home discharge
timeFrame: At Discharge (≤ 14 days following index procedure)
measure: Proportion of subjects discharged to home post index hospitalization
timeFrame: At Discharge (≤ 14 days following index procedure)
measure: 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.
timeFrame: 2 Years
measure: Severe symptomatic mitral stenosis at 1 year
timeFrame: 1 Year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Hospital - Univiversity of Alabama at Birmingham
state: Alabama
city: Mobile
country: United States
facility: Cardiology Associates of Mobile, Inc.
state: Alabama
city: Phoenix
country: United States
facility: Banner-University Medical Center Phoenix
state: Arizona
city: Phoenix
country: United States
facility: St. Josephs Hospital and Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Arizona Cardiovascular Research Center
state: Arizona
city: Tucson
country: United States
facility: Tucson Medical Center
state: Arizona
city: La Jolla
country: United States
facility: Scripps Memorial Hospital La Jolla
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Sacramento
country: United States
facility: Sutter Medical Center, Sacramento
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Thousand Oaks
country: United States
facility: Los Robles Regional Medical Center
state: California
city: Denver
country: United States
facility: Saint Joseph Hospital
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Bradenton
country: United States
facility: Manatee Memorial Hospital
state: Florida
city: Jacksonville
country: United States
facility: Baptist Medical Center
state: Florida
city: Naples
country: United States
facility: NCH Healthcare System
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Marietta
country: United States
facility: WellStar Kennestone Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Springfield
country: United States
facility: Prairie Education & Research Cooperative
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Hospital
state: Indiana
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Wichita
country: United States
facility: Via Christi Regional Medical Center - St. Francis Campus
state: Kansas
city: Wichita
country: United States
facility: Cardiovascular Research Institute of Kansas
state: Kansas
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Hospital, Royal Oak
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Morristown
country: United States
facility: Atlantic Health System - Morristown Memorial Hospital
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Bay Shore
country: United States
facility: South Shore University Hospital
state: New York
city: Buffalo
country: United States
facility: Buffalo General Hospital
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: New York-Presbyterian/Columbia University Medical Center
state: New York
city: Rochester
country: United States
facility: Rochester Regional Health
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Asheville
country: United States
facility: Mission Health & Hospitals
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Mt. Carmel East
state: Ohio
city: Oklahoma City
country: United States
facility: Integris Baptist Medical Center
state: Oklahoma
city: Harrisburg
country: United States
facility: Pinnacle Health System
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: PIttsburg
country: United States
facility: Allegheny General Hospital - ASRI
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Institute for Medical Research
state: Pennsylvania
city: Nashville
country: United States
facility: Centennial Medical Center
state: Tennessee
city: Nashville
country: United States
facility: St Thomas Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Heart & Vascular Institute
state: Tennessee
city: Austin
country: United States
facility: Ascension Texas Cardiovascular
state: Texas
city: Austin
country: United States
facility: Austin Heart
state: Texas
city: Houston
country: United States
facility: Park Plaza Hospital/HCA Hospital of Houston
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Seattle
country: United States
facility: The Heart Institute at Virginia Mason
state: Washington
city: Morgantown
country: United States
facility: West Virginia University Hospital
state: West Virginia
city: Ottawa
country: Canada
facility: Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Montréal
country: Canada
facility: Institut de Cardiologie de Montreal (Montreal Heart Inst.)
state: Quebec
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
state: Bad-wur
city: Frankfurt am Main
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
state: Hessen
city: Bad Oeynhausen
country: Germany
facility: Herz-und Diabetes Zentrum NRW
state: North Rhine-Westphalia
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
state: Rhinela
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
state: Saxony
city: München
country: Germany
facility: Deutsches Herzzentrum München des Freistaates Bayern
city: Rostock
country: Germany
facility: Universitätsklinikum Rostock (AöR)
city: Bern
country: Switzerland
facility: Center Inselspital Bern
Study officials:
affiliation: Northwestern Memorial Hospital
name: Patrick McCarthy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Los Robles Regional Medical Center
name: Saibal Kar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Abbott Structural Heart
name: Erin Spinner, PhD
role: STUDY_DIRECTOR
References:
citation: Kaneko T, Hirji S, Zaid S, Lange R, Kempfert J, Conradi L, Hagl C, Borger MA, Taramasso M, Nguyen TC, Ailawadi G, Shah AS, Smith RL, Anselmi A, Romano MA, Ben Ali W, Ramlawi B, Grubb KJ, Robinson NB, Pirelli L, Chu MWA, Andreas M, Obadia JF, Gennari M, Garatti A, Tchetche D, Nazif TM, Bapat VN, Modine T, Denti P, Tang GHL; CUTTING-EDGE Investigators. Mitral Valve Surgery After Transcatheter Edge-to-Edge Repair: Mid-Term Outcomes From the CUTTING-EDGE International Registry. JACC Cardiovasc Interv. 2021 Sep 27;14(18):2010-2021. doi: 10.1016/j.jcin.2021.07.029.