Transventricular Off-pump Mitral Valve Repair
ConditionMitral Valve (MV) Regurgitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorJohns Hopkins University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
TRANSOM
DeviceTRANSOM 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.
Treatment groups
175 Participants
are divided into 1 treatment groupGroup A: Transventricular off-pump mitral valve repairExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
30 days post-index procedure, or at hospital discharge approximately 4 days post index procedure2
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.
Time frame
1 year post-index procedure.Secondary outcomes
1
Technical Success
Technical success is defined as patient survival to exit from the operating room, successful implantation of at least three ePTFE cords, and absence of procedure-related emergency surgery or reintervention.
Time frame
Exit from operating room and up to 30 days post-procedure.2
Procedural Success
Procedural success includes technical success with absence of major adverse events, no structural or functional failure, and reduction of mitral regurgitation to acceptable levels.
Time frame
Exit from operating room and up to 30 days post-procedure.3
Patient Success
Defined as procedural success with patient return to the pre-procedural living setting, absence of rehospitalization or reintervention for mitral regurgitation, and appropriate improvement or stability in New York Heart Association (NYHA) functional class.
Time frame
1 year post-index procedure.4
Blood Product Usage
Blood product usage intraoperatively or post-operatively following the index procedure, measured as the number of blood product units transfused.
Time frame
Perioperative through hospital discharge (an average of 4 days following the index procedure).Sponsors and contacts
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Source ClinicalTrials.gov