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PRIMARY Ancillary Substudy

NCT07103733 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-08-19

No results posted yet for this study

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.

Conditions

  • Mitral Valve Prolapse
  • Left Ventricular Fibrosis
  • Ventricular 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.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Annetine Gelijns

    lead OTHER

Principal Investigators

  • Joanna Chikwe, MD · Cedars-Sinai

  • Martin Leon, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-16
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Device
Yes

Countries

  • United States
  • Germany
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07103733 on ClinicalTrials.gov