STS/ACC TVT Registry Mitral Module

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1+
SponsorAmerican College of Cardiology

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Leaflet Clip

    Device

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Number of Patients with Adverse Events

Time frame
30 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

American College of Cardiology

Lead sponsor

The Society of Thoracic Surgeons

Collaborator