Recruiting

TRANSOM

Sponsor:

Johns Hopkins University

Code:

NCT07726173

Conditions

Mitral Valve (MV) Regurgitation

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

TRANSOM

Study Details

Brief 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

Study ID

NCT07726173

Start date

Jun 8, 2026

Status verified date

Jul, 2026

Completion date

Jul 1, 2029

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Functional mitral regurgitation.
  • Severe mitral annular or leaflet calcification.
  • Significant concomitant valvular disease (e.g., severe aortic stenosis or insufficiency, severe tricuspid regurgitation).
  • Left ventricular ejection fraction <30% or severe right ventricular dysfunction.
  • Requirement for concomitant cardiac surgery.
  • Prior cardiac valve intervention or structural heart procedure (excluding prior PCI).
  • Recent major cardiovascular events (e.g., stroke or myocardial infarction within 30 days).
  • Hemodynamic instability or cardiogenic shock at the time of enrollment.
  • Significant comorbid conditions that increase procedural risk, including advanced liver disease, severe hematologic abnormalities, or active infection.
  • Contraindications to study procedures or required medications, including inability to tolerate anticoagulation or transesophageal echocardiography.
  • Pregnancy, lactation, or planned pregnancy during the study period.
  • Participation in another investigational device or drug study that could interfere with outcomes.
  • Life expectancy less than 12 months or any condition that, in the opinion of the investigator, precludes study participation.

Study Design

Enrollment

175 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Primary Safety Endpoint: Composite Freedom from Major Adverse Events [ Time Frame: 30 days post-index procedure, or at hospital discharge approximately 4 days post index procedure ]
  • Primary Effectiveness Endpoint: Composite Freedom from Death, Recurrent mitral regurgitation (MR), and Re-intervention [ Time Frame: 1 year post-index procedure. ]

Central Contacts and Locations

Central contacts

Lisa Fornaresio, PhD

443.927.3984lisa.fornaresio@jhmi.edu

Rachael Quinn, PhD

410.955.2800rquinn17@jhmi.edu

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Lisa Fornaresio, PhD

443-927-3984lisa.fornaresio@jhmi.edu

Rachael Quinn, PhD

410.955.2800rquinn17@jhmi.edu

Principal Investigator:

James S. Gammie, MD

More Information

Sponsor

Johns Hopkins University

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-07-24.