PRIMARY Ancillary Substudy

NARecruitingINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

October 16, 2023

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2027

Conditions
Mitral Valve ProlapseLeft Ventricular FibrosisVentricular Arrhythmias
Interventions
PROCEDURE

Cardiac Magnetic Resonance Imaging

Non-invasive imaging test that uses powerful magnets and radio waves to create detailed pictures of the heart without using radiation.

DEVICE

ZioPatch Monitoring

ZioPatch is a small, wearable heart monitor that sticks to the chest and records the heart's electrical activity continuously for up to 14 days. It helps doctors detect irregular heart rhythms (arrhythmias) without the need for bulky wires or equipment.

PROCEDURE

Myocardial Tissue Biopsy

During the MVr procedure, surgeons will biopsy approximately 50 μg of tissue from the endocardial and subendocardial myocardium in the inferobasilar and control areas using a surgical rongeur.

Trial Locations (25)

10065

RECRUITING

Weill Cornell Medicine/ New York-Presbyterian Hospital, New York

10075

RECRUITING

Northwell--Lenox Hill, North Shore, South Shore, Staten Island University Hospital, New York

13353

RECRUITING

Deutsches Herzzentrum der Charité, Berlin

21287

RECRUITING

The Johns Hopkins Hospital, Baltimore

22908

RECRUITING

University of Virginia Medical Center, Charlottesville

26506

RECRUITING

West Virginia University Hospital, Morgantown

27710

RECRUITING

Duke University Hospital, Durham

30309

RECRUITING

Piedmont Heart Institute, Atlanta

44195

RECRUITING

Cleveland Clinic, Cleveland

48109

RECRUITING

University of Michigan Hospital, Ann Arbor

64111

RECRUITING

Saint Luke's Hospital of Kansas City/MidAmerica Heart and Lung Surgeons, Kansas City

90033

RECRUITING

Keck Hospital of the University of Southern California, Los Angeles

90048

RECRUITING

Cedars-Sinai, Los Angeles

94143

RECRUITING

University of California San Francisco, San Francisco

94305

RECRUITING

Stanford University, Stanford

04102

RECRUITING

Maine Medical Center, Portland

02114

RECRUITING

Massachusetts General Hospital, Boston

04289

RECRUITING

Herzzentrum Leipzig, Leipzig

Unknown

RECRUITING

Royal Papworth Hospital NHS Foundation Trust, Trumpington

RECRUITING

Barts Health NHS Trust, Whitechapel

RECRUITING

Manchester University NHS Foundation Trust, Oxford

RECRUITING

South Tees Hospitals NHS Foundation Trust, Marton-in-Cleveland

LS9 7TF

RECRUITING

The Leeds Teaching Hospitals NHS Trust, Leeds

OX3 9DU

RECRUITING

Oxford University Hospitals NHS Foundation Trust, Oxford

BN11 2DH

RECRUITING

University Hospitals Sussex NHS Foundation Trust, Worthing

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Annetine Gelijns

OTHER