Actively Recruiting
PRIMARY Ancillary Substudy
Led by Annetine Gelijns · Updated on 2025-08-19
250
Participants Needed
25
Research Sites
193 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 PRIMARY trial (NCT05051033), which compares mitral valve repair (MVr) to transcatheter-edge-to-edge-repair (TEER), offers a platform for conducting mechanistic studies to develop early insights into the pathophysiological processes by which mitral valve prolapse (MVP) can impact left ventricular (LV) myocardial structure and function, and, thereby, predispose to arrhythmias and sudden death. Such insights are key to identifying interventions to reduce the long-term sequelae of heart failure (HF) and arrhythmias, as well as delineate optimal therapeutic approaches for different patient sub-groups.
CONDITIONS
Official Title
PRIMARY Ancillary Substudy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who meet all eligibility criteria and are randomized in the parent PRIMARY trial.
- Patients randomized to mitral valve repair (MVr) in the parent trial for the ancillary biospecimen study.
You will not qualify if you...
- Severe claustrophobia not controlled with sedation.
- Prior adverse reaction to gadolinium administration.
- Patients with implantable subcutaneous cardioverter defibrillator or cardiac resynchronization therapy device with defibrillator may be excluded due to MRI artifacts.
- Known allergic reaction to adhesives or hydrogels or family history of adhesive skin allergies (for patients undergoing rhythm monitoring).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 25 locations
1
Keck Hospital of the University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
2
Cedars-Sinai
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
Maine Medical Center
Portland, Maine, United States, 04102
Actively Recruiting
7
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
8
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
9
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
10
Saint Luke's Hospital of Kansas City/MidAmerica Heart and Lung Surgeons
Kansas City, Missouri, United States, 64111
Actively Recruiting
11
Weill Cornell Medicine/ New York-Presbyterian Hospital
New York, New York, United States, 10065
Actively Recruiting
12
Northwell--Lenox Hill, North Shore, South Shore, Staten Island University Hospital
New York, New York, United States, 10075
Actively Recruiting
13
Duke University Hospital
Durham, North Carolina, United States, 27710
Actively Recruiting
14
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
15
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
16
West Virginia University Hospital
Morgantown, West Virginia, United States, 26506
Actively Recruiting
17
Deutsches Herzzentrum der Charité
Berlin, Germany, 13353
Actively Recruiting
18
Herzzentrum Leipzig
Leipzig, Germany, 04289
Actively Recruiting
19
Royal Papworth Hospital NHS Foundation Trust
Trumpington, Cambridge, United Kingdom
Actively Recruiting
20
The Leeds Teaching Hospitals NHS Trust
Leeds, England, United Kingdom, LS9 7TF
Actively Recruiting
21
Barts Health NHS Trust
Whitechapel, London, United Kingdom
Actively Recruiting
22
Manchester University NHS Foundation Trust
Oxford, Manchester, United Kingdom
Actively Recruiting
23
South Tees Hospitals NHS Foundation Trust
Marton-in-Cleveland, Middlesbrough, United Kingdom
Actively Recruiting
24
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Actively Recruiting
25
University Hospitals Sussex NHS Foundation Trust
Worthing, West Sussex, United Kingdom, BN11 2DH
Actively Recruiting
Research Team
C
Chari Ponder, RN, BSN
CONTACT
J
Jonathan Hupf
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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