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Transventricular Off-pump Mitral Valve Repair

NCT07726173 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2026-07-24

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and effectiveness (usefulness) of an investigational technique used to repair the mitral valve for patients with mitral regurgitation due to a defective valve leaflet. This procedure is called trans-ventricular off-pump mitral valve repair (TRANSOM) and it repairs the mitral valve by replacing some of the cords that support the mitral valve. This type of repair is minimally-invasive since it is performed through a small incision and avoids making a breast-bone-splitting incision.

Conditions

  • Mitral Valve (MV) Regurgitation

Interventions

DEVICE

TRANSOM

TRANSOM is a minimally-invasive treatment that involves making a small incision between the ribs of the left chest, inserting a thin tube directly into the heart while it is beating, and placing the suture material onto the edges of the valve flaps so that the valves come together properly.

Sponsors & Collaborators

Principal Investigators

  • James Gammie, MD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-08
Primary Completion
2027-07-01
Completion
2029-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT07726173 on ClinicalTrials.gov