PRIMARY Ancillary Substudy

Conditions

• Left Ventricular Fibrosis
• Mitral Valve Prolapse
• Ventricular Arrhythmias

Eligibility Criteria

Sex

ALL

Age

60 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cardiac Magnetic Resonance Imaging — PROCEDURE
  Non-invasive imaging test that uses powerful magnets and radio waves to create detailed pictures of the heart without using radiation.
• ZioPatch Monitoring — DEVICE
  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.
• Myocardial Tissue Biopsy — PROCEDURE
  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.

Study Details

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.

Key Dates

Start date

Oct 16, 2023

Status verified

Aug 2025

Primary completion

Jun 30, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

250 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• 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.

Primary Outcome Measure

Presence of Myocardial Fibrosis [ Time Frame: 1 year post index procedure. ]

Central Contacts

• Chari Ponder, RN, BSN
  (646) 899-8106
  [email protected]
• Jonathan Hupf
  (646) 385-0854
  [email protected]

Locations (16)

Find similar trials in Los Angeles, CA

Related Studies

• Patient-Centered Approach for Treatment Decisions in Mitral Valve Prolapse
  Recruiting · Northwell Health · Los Angeles, California