Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING NA

PRIMARY Ancillary Substudy

NCT07103733 · View on ClinicalTrials.gov ↗

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.

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

Sponsor

Annetine Gelijns

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07103733

The ClinicalTrials.gov registry entry for NCT07103733 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Annetine Gelijns, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07103733 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, New York, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07103733?

This trial is sponsored by Annetine Gelijns, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial