Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY) Ancillary Substudy

Status: Recruiting
Location: See all (25) locations...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• Patients who meet all eligibility criteria and are randomized in the parent PRIMARY trial.

• For the ancillary biospecimen study, patients who are randomized to MVr in the parent trial.

Locations
United States
California
Cedars-Sinai
RECRUITING
Los Angeles
Keck Hospital of the University of Southern California
RECRUITING
Los Angeles
University of California San Francisco
RECRUITING
San Francisco
Stanford University
RECRUITING
Stanford
Georgia
Piedmont Heart Institute
RECRUITING
Atlanta
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Maryland
The Johns Hopkins Hospital
RECRUITING
Baltimore
Maine
Maine Medical Center
RECRUITING
Portland
Michigan
University of Michigan Hospital
RECRUITING
Ann Arbor
Missouri
Saint Luke's Hospital of Kansas City/MidAmerica Heart and Lung Surgeons
RECRUITING
Kansas City
North Carolina
Duke University Hospital
RECRUITING
Durham
New York
Northwell--Lenox Hill, North Shore, South Shore, Staten Island University Hospital
RECRUITING
New York
Weill Cornell Medicine/ New York-Presbyterian Hospital
RECRUITING
New York
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Virginia
University of Virginia Medical Center
RECRUITING
Charlottesville
West Virginia
West Virginia University Hospital
RECRUITING
Morgantown
Other Locations
Germany
Deutsches Herzzentrum der Charité
RECRUITING
Berlin
Herzzentrum Leipzig
RECRUITING
Leipzig
United Kingdom
The Leeds Teaching Hospitals NHS Trust
RECRUITING
Leeds
South Tees Hospitals NHS Foundation Trust
RECRUITING
Marton-in-cleveland
Manchester University NHS Foundation Trust
RECRUITING
Oxford
Oxford University Hospitals NHS Foundation Trust
RECRUITING
Oxford
Royal Papworth Hospital NHS Foundation Trust
RECRUITING
Trumpington
Barts Health NHS Trust
RECRUITING
Whitechapel
University Hospitals Sussex NHS Foundation Trust
RECRUITING
Worthing
Contact Information
Primary
Chari Ponder, RN, BSN
chari.ponder@mountsinai.org
(646) 899-8106
Backup
Jonathan Hupf
Jonathan.Hupf@mountsinai.org
(646) 385-0854
Time Frame
Start Date: 2023-10-16
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 250
Treatments
Active_comparator: Mitral valve repair
Mitral surgery will be conducted using general anesthesia and cardiopulmonary bypass. Mitral surgery may be performed via a sternotomy or a right thoracotomy approach with or without robotic assistance.
Active_comparator: Transcatheter edge-to-edge repair
Patients will be treated with a commercially-approved edge-to-edge mitral repair device.
Sponsors
Leads: Annetine Gelijns
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov