Clinical Trials Logo

Clinical Trial Summary

The goal of this study is to determine the short term safety (<30 days) and efficacy (6 months) of the heterotopic implantation of the Edwards-Sapien XT valve in the inferior vena cava for the treatment of severe tricuspid regurgitation in patients who are inoperable or at a very high surgical risk for tricuspid valve replacement.


Clinical Trial Description

This is a prospective multi-center, non-blinded (open label), non-randomized safety and feasibility study of the heterotopic implantation of the Edwards-Sapien XT or S3 valve in the inferior vena cava for the treatment of severe tricuspid regurgitation in patients who are inoperable or at a very high surgical risk for tricuspid valve replacement. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02339974
Study type Interventional
Source Henry Ford Health System
Contact
Status Active, not recruiting
Phase Phase 3
Start date January 2015
Completion date May 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05434507 - Feasibility Study of Treating Tricuspid Regurgitation With K-ClipTM Transcatheter Annuloplasty System N/A
Completed NCT03144024 - Comparison of Rigid Annuloplasty Ring With a Band in the Correction of Secondary Tricuspid Insufficiency N/A
Enrolling by invitation NCT05825898 - Outcome of Patients With Severe Functional TR According to Medical, Transcatheter or Surgical Treatment
Completed NCT05836493 - Very Long-term (>15 Years) Results of Tricuspid Valve Repair.
Enrolling by invitation NCT06033274 - Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment
Recruiting NCT05671640 - Feasibility Study of the DragonFly-T System for Severe Tricuspid Regurgitation N/A
Recruiting NCT06027307 - Enavogliflozin Outcome Trial in Functional Tricuspid Regurgitation Phase 3
Terminated NCT04665583 - Prehab Prior to Undergoing Tricuspid Intervention
Recruiting NCT06307262 - European Registry of Transcatheter Repair for Tricuspid Regurgitation
Completed NCT02981953 - TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System N/A
Recruiting NCT04433065 - TTVR Early Feasibility Study N/A
Not yet recruiting NCT05556460 - Safety and Effectiveness Study of DragonFly-T System for Severe Tricuspid Regurgitation N/A
Recruiting NCT05667519 - Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE) N/A
Recruiting NCT04653428 - German Registry for Transcatheter Tricuspid Valve Interventions
Recruiting NCT05179616 - Pforzheim Tricuspid Valve Registry - Outcomes of Percutaneous Tricuspid Valve Repair
Completed NCT02644616 - The Safety and Efficacy of Tolvaptan for Patients With Tricuspid Regurgitation and Right Heart Failure After Left Heart Valves Replacement Phase 4
Recruiting NCT05328284 - PASCAL for Tricuspid Regurgitation - a European Registry
Active, not recruiting NCT02675244 - Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery N/A
Recruiting NCT05436028 - A Study to Evaluate the Safety and Performance of LuX-Valve Plus System for Tricuspid Replacement N/A
Completed NCT01093001 - Tricuspid Regurgitation Study Phase 4