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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 21 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • 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.

Recruiting Locations

Johns Hopkins Hospital
Baltimore, Maryland 21287
Contact:
Lisa Fornaresio, PhD
443-927-3984
lisa.fornaresio@jhmi.edu

More Details

Status
Recruiting
Sponsor
Johns Hopkins University

Study Contact

Lisa Fornaresio, PhD
443.927.3984
lisa.fornaresio@jhmi.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.