NCT07726173 Transventricular Off-pump Mitral Valve Repair
| NCT ID | NCT07726173 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Mitral Valve (MV) Regurgitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 175 participants |
| Start Date | 2026-06-08 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 175 participants in total. It began in 2026-06-08 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
James Gammie, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT07726173 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Mitral Valve (MV) Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07726173 currently recruiting?
Yes, NCT07726173 is actively recruiting participants. Contact the research team at lisa.fornaresio@jhmi.edu for enrollment information.
Where is the NCT07726173 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT07726173 clinical trial?
NCT07726173 is sponsored by Johns Hopkins University. The principal investigator is James Gammie, MD at Johns Hopkins University. The trial plans to enroll 175 participants.