First in Human Study of the DaVingi™ TR System in the Treatment of Patients With Functional Tricu… (NCT03700918) | Clinical Trial Compass
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First in Human Study of the DaVingiâ„¢ TR System in the Treatment of Patients With Functional Tricuspid Regurgitation
Czechia, France, Israel15 participantsStarted 2017-11-11
Plain-language summary
The DaVingiâ„¢ System is a percutaneous trans-catheter device delivered using right heart catheterization through the right internal jugular vein. The DaVingiâ„¢ System is designed for performing ring annuloplasty by using a Ring Delivery System to place a complete, flexible fabric ring around the annulus of the atrial side of the tricuspid valve. Fluoroscopy and echocardiography are used to monitor the ring placement procedure.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Severe tricuspid regurgitation as defined by American Society of Echocardiography.
✓. Symptoms of right ventricular failure despite appropriate medical therapy.
✓. Multidisciplinary heart team (minimum of three physicians, including cardiology and cardiac surgery representatives) recommends tricuspid annuloplasty.
✓. ≥18 years old at time of enrollment.
✓. LVEF ≥ 30% within 45 days prior to index implant procedure.
✓. PASP \< 70 mmHg via right heart catheterization (subject at rest) within 90 days prior to index implant procedure.
✓. Right Ventricle TAPSE ≥ 13 mm within 45 days prior to index implant procedure.
✓. Tricuspid valve annular diameter ≥ 40 mm as measured by baseline transthoracic echocardiography in the 4 chamber view within 45 days prior to index implant procedure.
Exclusion criteria
✕. Acutely decompensated heart failure (i.e. hemodynamically unstable or on IV inotropes).
✕. Previous tricuspid valve repair or replacement.
What they're measuring
1
Safety- the incidence and severity of device-related serious adverse device effects (SADE)
Timeframe: from time of index implant/ adjustment procedure through 30 days post-implant
2
Device performance - Adjustment Device Technical Success: Rate of successful adjustment of the DaVingiâ„¢ TR ring at the tricuspid annulus, desired by physician