Actively Recruiting
Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for 60 Year-olds and Older
Led by Annetine Gelijns · Updated on 2026-03-03
450
Participants Needed
61
Research Sites
104 weeks
Total Duration
On this page
Sponsors
A
Annetine Gelijns
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The trial investigates treatment options for adults aged 60 and older with severe primary degenerative mitral regurgitation (MR). It compares two approaches: transcatheter edge-to-edge repair (TEER) and surgical mitral valve repair. The study aims to evaluate long-term effectiveness and safety, along with patient-centered outcomes such as quality of life and functional status, over a follow-up period of up to 10 years. This research is conducted across multiple countries and includes patients considered suitable for both treatment methods by their heart team. Participants are randomly assigned to one of two treatment groups: surgical mitral valve repair or TEER. Surgical repair involves heart surgery under general anesthesia, possibly using a sternotomy or thoracotomy approach with techniques to correct valve issues. TEER uses a catheter-based device inserted through the femoral vein to repair the valve with image guidance. Both procedures are performed according to standard medical practices and device instructions. The study includes an enrollment period of about three years, with follow-up assessments extending up to a decade. During the study, patients undergo regular evaluations including echocardiograms, heart failure assessments, and quality of life questionnaires such as the Kansas City Cardiomyopathy Questionnaire and 6-minute walk test. Outcomes measured include mortality, hospitalizations, valve function, and adverse events. Data collection also involves administrative records to track long-term clinical events. The primary outcome focuses on a composite of mortality, heart failure events, valve re-intervention, and mitral regurgitation severity at three years post intervention.
CONDITIONS
Brief Title
Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 60 years or older
- Severe primary degenerative mitral regurgitation (3+ or 4+/4+) confirmed by transthoracic echocardiography
- Clinical indication for mitral valve intervention
- Anatomical suitability for both surgical mitral valve repair and transcatheter edge-to-edge repair as assessed by local heart team and verified by central eligibility committee
- Patients across surgical risk levels (low, intermediate, high) as determined by local heart team and central eligibility committee
- Ability to perform 6-minute walk test and complete Kansas City Cardiomyopathy Questionnaire
You will not qualify if you...
- Non-degenerative primary mitral regurgitation types (e.g., cleft leaflet)
- Secondary or functional mitral regurgitation
- Hypertrophic obstructive cardiomyopathy
- Presence of inferior vena cava filter or permanent pacing/ICD leads interfering with transcatheter repair
- Known allergy to intravenous contrast
- Febrile illness within 30 days before randomization
- Contraindications to transesophageal echocardiography or systemic heparinization
- Coronary artery disease requiring revascularization
- Prior mitral valve intervention or atrial septal defect repair
- Need for concomitant aortic valve, aortic surgery, or tricuspid valve surgery
- Emergency interventions or surgeries
- Active endocarditis
- Hemodynamic instability (cardiac index <2.0 l/min/m2, systolic blood pressure <90 mmHg, need for inotropic or mechanical support)
- Left ventricular ejection fraction below 25%
- Intracardiac mass or thrombus
- Medical or oncologic conditions limiting survival beyond 2 years
- Active substance abuse
- Suspected inability to adhere to follow-up
- Participation in another investigational drug or intervention that interferes with study endpoints
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with hospital stay
Participants receive either surgical mitral valve repair or transcatheter edge-to-edge mitral valve repair to treat severe primary degenerative mitral regurgitation.
1 hospitalization period including surgery or device implantation
Duration - Up to 10 years post intervention
Participants are monitored for safety, valve function, heart failure symptoms, quality of life, and other health outcomes over several years after the intervention.
Regular follow-up visits and assessments over 10 years
Trial Site Locations
Total: 61 locations
1
Keck Hospital of the University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
2
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
3
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
4
Stanford University
Stanford, California, United States, 94305
Actively Recruiting
5
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
Actively Recruiting
6
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
7
Ochsner Clinic
New Orleans, Louisiana, United States, 70121
Actively Recruiting
8
Maine Medical Center
Portland, Maine, United States, 04102
Actively Recruiting
9
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
10
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
11
Brigham and Women's
Boston, Massachusetts, United States, 02115
Actively Recruiting
12
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
13
Saint Luke's Hospital of Kansas City/MidAmerica Heart and Lung Surgeons
Kansas City, Missouri, United States, 64111
Actively Recruiting
14
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
15
New York-Presbyterian/Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
16
Weill Cornell Medicine/ New York-Presbyterian Hospital
New York, New York, United States, 10065
Actively Recruiting
17
Northwell Health
New York, New York, United States, 21287
Actively Recruiting
18
Duke University Hospital
Durham, North Carolina, United States, 27710
Actively Recruiting
19
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
20
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
21
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
22
Baylor, Scott and White
Dallas, Texas, United States, 75246
Actively Recruiting
23
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22903
Actively Recruiting
24
West Virginia University Hospital
Morgantown, West Virginia, United States, 26506
Actively Recruiting
25
University of British Columbia, Providence Health Care, St. Paul's Hospital
Vancouver, British Columbia, Canada, BC V6E 1M7
Actively Recruiting
26
London Health Sciences
London, Ontario, Canada, ON N6A 5W9
Actively Recruiting
27
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Actively Recruiting
28
Unity Health Toronto (St. Michael's Hospital)
Toronto, Ontario, Canada, M5B 1W8St
Actively Recruiting
29
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (Laval University)
Québec, Quebec, Canada, QC G1V 4G5
Actively Recruiting
30
Universitätsklinikum Köln
Cologne, Berlin-kölnische Allee, Germany, 50969
Actively Recruiting
31
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545
Actively Recruiting
32
Kerckhoff Klinik Bad Nauheim
Bad Nauheim, Germany, 61231
Actively Recruiting
33
Schüchtermann-Klinik Bad Rothenfelde
Bad Rothenfelde, Germany, 49214
Actively Recruiting
34
Deutsches Herzzentrum der Charité
Berlin, Germany, 13353
Actively Recruiting
35
Universitätsklinikum Frankfurt
Frankfurt, Germany, 60590
Actively Recruiting
36
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
37
Asklepios Klinik St. Georg Hamburg
Hamburg, Germany, 20099
Active, Not Recruiting
38
Universitätsklinikum Hamburg Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
39
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Active, Not Recruiting
40
Universitätsklinikum Jena
Jena, Germany, 07747
Actively Recruiting
41
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, Germany, 24105
Actively Recruiting
42
Herzzentrum Leipzig
Leipzig, Germany, 04289
Actively Recruiting
43
Universitätsklinikum Schleswig-Holstein Campus Lübeck
Lübeck, Germany, 23538
Actively Recruiting
44
Deutsches Herzzentrum München
München, Germany, 80636
Actively Recruiting
45
Hospital Alvaro Cunqueiro
Vigo, Galacia, Spain, 36204
Actively Recruiting
46
Hospital Clinic De Barcelona
Barcelona, Spain, 08036
Actively Recruiting
47
Hospital Clínico San Carlos
Madrid, Spain, 28040
Actively Recruiting
48
Hospital Central de Asturias
Oviedo, Spain, 33011
Actively Recruiting
49
Royal Papworth Hospital NHS Foundation Trust
Cambridge, England, United Kingdom, CB2 0AY
Actively Recruiting
50
The Leeds Teaching Hospitals NHS Trust
Leeds, England, United Kingdom, LS1 3EX
Actively Recruiting
51
St. Thomas Guy's and St Thomas' NHS Foundation Trust
London, England, United Kingdom, SE1 7EH
Actively Recruiting
52
King's College Hospital NHS Foundation Trust
London, England, United Kingdom, SE5 9RS
Actively Recruiting
53
Royal Brompton and Harefield Guy's and St Thomas' NHS Foundation Trust
London, England, United Kingdom, SW3 6NP
Actively Recruiting
54
Manchester University NHS Foundation Trust
Manchester, England, United Kingdom, M23 9LT
Actively Recruiting
55
University Hospitals Sussex NHS Foundation Trust
Worthing, West Sussex, United Kingdom, BN2 5BE
Actively Recruiting
56
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom, B15 2TH
Actively Recruiting
57
Golden Jubilee University National Hospital
Clydebank, United Kingdom, G81 4DY
Actively Recruiting
58
Oxford University Hospitals NHS Foundation Trust
Headington, United Kingdom, OX3 9DU
Actively Recruiting
59
Barts Health NHS Trust
London, United Kingdom, E1 8PR
Actively Recruiting
60
South Tees Hospitals NHS Foundation Trust
Middlesbrough, United Kingdom, TS4 3BW
Actively Recruiting
61
South Tees Hospital NHS Foundation Trust
Middlesbrough, United Kingdom
Actively Recruiting
Research Team
C
Chari Ponder, RN, BSN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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