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NCT07103733 · ClinicalTrials.gov registry record · NA

PRIMARY Ancillary Substudy

A NA study of Ventricular Arrhythmias and Mitral Valve Prolapse, sponsored by Annetine Gelijns.

Recruiting
Registry status
NA
Development phase
250
Enrollment target
20
Study locations

NCT07103733: Recruiting NA study of Ventricular Arrhythmias and Mitral Valve Prolapse, sponsored by Annetine Gelijns.

NCT07103733 is a NA study of Ventricular Arrhythmias and Mitral Valve Prolapse that is actively recruiting participants, run by Annetine Gelijns. The registered enrollment target is 250 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07103733, a NA study of Ventricular Arrhythmias and Mitral Valve Prolapse, is actively recruiting participants, sponsored by Annetine Gelijns.

RECRUITING
Registry status
NA
Development phase
250 participants
Enrollment target
20
Study locations

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.

Primary Outcome

Myocardial fibrosis is the buildup of excess fibrous connective tissue in the heart muscle often resulting from chronic injury or stress. It can impair the heart's ability to contract and relax properly leading to reduced cardiac function.

Interventions

  • PROCEDURE Cardiac Magnetic Resonance Imaging
  • DEVICE ZioPatch Monitoring
  • PROCEDURE Myocardial Tissue Biopsy

Study Locations (20)

California

  • Keck Hospital of the University of Southern California - Los Angeles
  • Cedars-Sinai - Los Angeles
  • University of California San Francisco - San Francisco
  • Stanford University - Stanford

New York

  • Weill Cornell Medicine/ New York-Presbyterian Hospital - New York
  • Northwell--Lenox Hill, North Shore, South Shore, Staten Island University Hospital - New York

Other

  • Deutsches Herzzentrum der Charité - Berlin
  • Herzzentrum Leipzig - Leipzig

Georgia

  • Piedmont Heart Institute - Atlanta

Maine

  • Maine Medical Center - Portland

Maryland

  • The Johns Hopkins Hospital - Baltimore

Massachusetts

  • Massachusetts General Hospital - Boston

Michigan

  • University of Michigan Hospital - Ann Arbor

Trial Details

FieldValue
Enrollment Target 250 participants
Start Date 2023-10-16
Est. Completion 2027-06-30
Phase NA
Annetine Gelijns

4 total trials

What NCT07103733 shows while recruiting

NCT07103733 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower).

The record links to 3 conditions, with Ventricular Arrhythmias appearing as the primary indexed condition, and to 3 interventions - of which Cardiac Magnetic Resonance Imaging is the first listed.

NCT07103733 names 20 study sites across 15 states, led by California, New York, Other.

Frequently Asked Questions

What is clinical trial NCT07103733 about?

NCT07103733 is a clinical study titled "PRIMARY Ancillary Substudy". 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...

What is the current status of trial NCT07103733?

This trial is currently recruiting. It is a NA study. The enrollment target is 250 participants. The study started on 2023-10-16. Estimated completion is 2027-06-30.

What conditions does trial NCT07103733 study?

This clinical trial studies the following conditions: Ventricular Arrhythmias, Mitral Valve Prolapse, Left Ventricular Fibrosis.

What interventions are being tested in trial NCT07103733?

The interventions under investigation include: Cardiac Magnetic Resonance Imaging (PROCEDURE), ZioPatch Monitoring (DEVICE), Myocardial Tissue Biopsy (PROCEDURE).

Who is sponsoring clinical trial NCT07103733?

This trial is sponsored by Annetine Gelijns, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07103733 being conducted?

This trial has 20 study locations across California, Georgia, Maine, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Ventricular Arrhythmias

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07103733's enrollment target sits among peer trials

250 410th of 2000 higher than 1,567 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07103733, the US trial registry maintained by the National Library of Medicine. NCT07103733 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.