Mitral Valve Regurgitation Clinical Trials

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Transventricular Off-pump Mitral Valve Repair (TRANSOM)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

• Age 21 years or older.

• Presence of severe degenerative mitral regurgitation confirmed by echocardiography.

• Mitral leaflet anatomy suitable for coaptation to allow reduction of mitral regurgitation without undue leaflet tension.

• Ability to provide informed consent and willingness to comply with study procedures and follow-up.

Locations
United States
Maryland
Johns Hopkins Hospital
RECRUITING
Baltimore
Contact Information
Primary
Lisa Fornaresio, PhD
lisa.fornaresio@jhmi.edu
443.927.3984
Backup
Rachael Quinn, PhD
rquinn17@jhmi.edu
410.955.2800
Time Frame
Start Date: 2026-06-08
Estimated Completion Date: 2029-07-01
Participants
Target number of participants: 175
Treatments
Experimental: Transventricular off-pump mitral valve repair
Participants with severe degenerative mitral regurgitation will undergo transventricular off-pump mitral valve repair for the treatment of degenerative mitral regurgitation.
Related Therapeutic Areas
Sponsors
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov