About this trial
The TVT Registry™ is a benchmarking tool developed to track patient safety and real-world outcomes related to the transcatheter mitral valve repair (TMVR) procedure. Created by The Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC), the TVT Registry is designed to monitor the safety and efficacy of this new procedure for the treatment of mitral valve disease.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
All patients
Disqualifiers
Patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen
Active endocarditis of the mitral valve
Rheumatic mitral valve disease
Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus
Trial population
Transcatheter Mitral Valve Repair must be furnished in a hospital with the appropriate infrastructre that includes, but is not limited to on site heart valve surgery program cardiac catheterization lab or hybrid operating room with a fixed radiographic imaging system with flat panel fluoroscopy, offering quality imaging non-invasive imaging such as echocardiography, vascular ultrasound, computed tomography and magnetic resonance. Sufficient space, in a sterile environment, to accommodate necessary equipment for cases with and without complications. Post-procedure intensive care facility with personnel experienced in managing patients who have undergone open-heart valve procedures.
Trial design
Cohort
Prospective
Treatments tested in this trial
Leaflet Clip
Device
Treatment groups
Trial outcomes
Primary outcomes
Number of Patients with Adverse Events
Sponsors and contacts
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American College of Cardiology
Lead sponsor
The Society of Thoracic Surgeons
Collaborator