Menu
Recruiting NCT07726173

Transventricular Off-pump Mitral Valve Repair

No phase Interventional Mitral Valve (MV) Regurgitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TRANSOM.
Who it may be relevant to
Registry conditions: Mitral Valve (MV) Regurgitation. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Transventricular Off-pump Mitral Valve Repair (TRANSOM)

Overview

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.

Detailed description

The key advantages of TRANSOM are that it is less invasive, requiring a small non-rib-spreading chest incision rather than a sternotomy, which splits the breastbone.

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.

Primary outcome measures

  • 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.]
Secondary outcome measures (12)
  • Technical Success [Time frame: Exit from operating room and up to 30 days post-procedure.]
  • Procedural Success [Time frame: Exit from operating room and up to 30 days post-procedure.]
  • Patient Success [Time frame: 1 year post-index procedure.]
  • Blood Product Usage [Time frame: Perioperative through hospital discharge (an average of 4 days following the index procedure).]
  • Procedure Time [Time frame: During the index procedure.]
  • Operating Room Time [Time frame: During the index procedure.]
  • Percentage of Subjects Receiving Mitral Valve Replacement (MVR) [Time frame: During the index procedure.]
  • Composite Effectiveness Endpoint [Time frame: 1 year post-index procedure.]
  • Discharged to Home vs Other Facility [Time frame: At hospital discharge (an average of 4 days following the index procedure).]
  • New York Heart Association (NYHA) Functional Class [Time frame: Baseline and at 30 days, 12, 24, 36, 48, and 60 months post-procedure.]
  • Mitral Regurgitation Grade [Time frame: Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.]
  • Left Ventricular End Diastolic Diameter (LVEDD) [Time frame: Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Johns Hopkins Hospital — Baltimore

Identifiers

NCT: NCT07726173 · IRB00416988

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗