Health Condition 1: I368- Other nonrheumatic tricuspid valvedisorders
Conditions
Interventions
Intervention1: TricValve Transcatheter Bicaval Valves System: TricValve Transcatheter Bicaval Valves System is designed to address severe Tricuspid Regurgitation (TR). It is a device to be implanted t
Sponsors
Relisys Medical Devices Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patient must be 18 years of age or older; irrespective of gender 2. Patient with significant backflow by echo / doppler in the lower IVC and / or upper SVC 3. V wave > 15 mm Hg on right heart catheterization measured in IVC and/or SVC 2 to 4 cm above or below the RA inflow 4. Symptomatic patients with NYHA class III or IV (prior to TricValve® implant) 5. Patient/authorized legal guardian understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provides written informed consent 6. Patient is geographically stable (or willing to return for required study follow-up) and understands and is willing to fulfill all the expected requirements of this clinical protocol 7. LVEF > 40% on Echocardiography/ Doppler. 8. Distance covered in 6 MWT > 60 meters
Exclusion criteria
Exclusion criteria: 1. Known significant intracardiac shunt (eg ventricular septal defect) or congenital structural heart disease based on heart teams evaluation 2. Requirement for other elective cardiac procedures eg PCI (percutaneous treatment of coronary artery) or CABG (coronary artery bypass surgery) up to 90 days after the procedure or history of such procedure within 30 days before the procedure 3. Presence of any known life-threatening non-cardiac (major or progressive) disease that will limit the patients life expectancy to less than one year 4. Cerebro-vascular event within the past 3 months 5. History of mitral or tricuspid endocarditis within the last 12 months 6. Documented evidence of significant renal dysfunction (serum creatinine more than 3.0mg per dl) or on any form of dialysis at time of screening within the last 4 weeks 7. Evidence of an acute myocardial infarction (AMI) in last 30 days 8. Female patient of child-bearing potential 9. Psychiatric or behavioral disease including known alcohol or drug abuser (continued use of alcohol, illegal drugs, or the misuse of prescription or over-the-counter drugs with negative physical or psychological consequences) that is likely to impair compliance with the protocol 10. Currently participating in another study of an investigational drug or device that would directly impact the treatment or outcome of the current study 11. SPAP more than 65 mm of Hg TAPSE less than 13 mm of Hg 12. In the investigators opinion, any significant medical condition which may interfere with the patients optimal participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the clinical efficacy of TricValve Transcatheter Bicaval Valves System for 3 months after treatment on the basis of 2D Echo & questionnaireTimepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ To assess safety of the TricValve® Transcatheter Bicaval Valves System through 12 months â?¢ To assess survival rate in patients with severe tricuspid regurgitation at risk for surgery â?¢ To assess impact of the TricValve® Transcatheter Bicaval Valves System on functional capacity by assessment done with 6 MWTTimepoint: 30 days, 3rd month, 6th month, 9th month & 12th month | — |
Countries
India
Contacts
Public ContactSharvari Rangnekar Rangnekar
Questt Clinicals and Ayurceuticals Pvt. Ltd
Outcome results
None listed