Transventricular Off-pump Mitral Valve Repair

NCT07726173 | Recruiting DMC FDA Device

• 1 other identifier: IRB00416988
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint: Composite Freedom from Major Adverse Events

  Freedom from a composite of major adverse events including all-cause mortality, all stroke, acute kidney injury (AKI), major bleeding, new permanent pacemaker implantation, deep sternal wound infection (DSWI) or access site infection requiring surgical intervention, and prolonged mechanical ventilation.

  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

  Freedom from all-cause mortality, recurrent moderate or severe mitral regurgitation, and re-intervention on the mitral valve.

  1 year post-index procedure.

Secondary Outcomes (26)

• Technical Success

  Exit from operating room and up to 30 days post-procedure.

• Procedural Success

  Exit from operating room and up to 30 days post-procedure.

• Patient Success

  1 year post-index procedure.

• Blood Product Usage

  Perioperative through hospital discharge (an average of 4 days following the index procedure).

• Procedure Time

  During the index procedure.

Study Arms (1)

Transventricular off-pump mitral valve repair

EXPERIMENTAL

Participants with severe degenerative mitral regurgitation will undergo transventricular off-pump mitral valve repair for the treatment of degenerative mitral regurgitation.

Device: TRANSOM

Interventions

TRANSOM DEVICE

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.

Transventricular off-pump mitral valve repair

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• James Gammie, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Fornaresio, PhD

CONTACT

443.927.3984; lisa.fornaresio@jhmi.edu

Rachael Quinn, PhD

CONTACT

410.955.2800; rquinn17@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 24, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2029
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)