Actively Recruiting
Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)
Led by Annetine Gelijns · Updated on 2026-03-03
450
Participants Needed
61
Research Sites
455 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
This is a prospective, multicenter, open-label, randomized trial comparing mitral valve (MV) transcatheter edge-to-edge repair (TEER) to surgical repair (1:1 ratio) in patients with primary, degenerative mitral regurgitation (MR). The trial will be conducted in the U.S., Canada, Germany, Spain, and the United Kingdom, and is designed as a strategy trial. Thus, all devices legally marketed for TEER of primary degenerative MR in a particular country are eligible to be used in this trial.
CONDITIONS
Official 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...
- Adult patients 60 years or older with moderately-severe or severe primary degenerative mitral regurgitation confirmed by transthoracic echocardiography
- Clinical indication for mitral valve intervention and anatomical suitability for both surgical and transcatheter edge-to-edge repair as confirmed by local heart team and central eligibility committee
- Patients across all surgical risk levels (low, intermediate, high) based on heart team assessment and guidelines
- Patients with atrial fibrillation eligible for concomitant ablation if deemed appropriate
- Ability to perform a 6-minute walk test and complete the Kansas City Cardiomyopathy Questionnaire
You will not qualify if you...
- Non-degenerative types of primary mitral regurgitation such as cleft leaflet
- Secondary or functional mitral regurgitation
- Hypertrophic obstructive cardiomyopathy
- Presence of an inferior vena cava filter or permanent pacing/ICD leads interfering with transcatheter repair
- Known allergic reactions to intravenous contrast
- Recent febrile illness within 30 days prior to randomization
- Contraindications to transesophageal echocardiography or systemic heparinization
- Coronary artery disease requiring revascularization
- Any prior mitral valve intervention or atrial septal defect repair
- Need for concomitant procedures like aortic valve or tricuspid valve surgery
- Emergency interventions or surgeries required
- Active endocarditis
- Hemodynamic instability or low heart function
- Left ventricular ejection fraction below 25%
- Presence of intracardiac mass or thrombus
- Co-morbid conditions limiting survival to less than 2 years
- Active substance abuse
- Suspected inability to adhere to follow-up
- Treatment with other investigational drugs or interventions that interfere with study endpoints
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here