Clinical Trials Logo

Clinical Trial Summary

The primary purpose of this study is to evaluate safety and effectiveness of the Tricuspid Valve Repair System (TVRS) for treating symptomatic moderate or greater tricuspid regurgitation (TR) in patients currently on medical management and who are deemed appropriate for percutaneous transcatheter intervention.


Clinical Trial Description

This is a prospective, single arm, multi-center study. A minimum of 85 subjects will be prospectively enrolled into this single arm study in approximately 25 sites, in Europe, Canada and the United States. Patients will be seen for follow-up visits at discharge (≤ 7 days post index procedure), 30 days, 6 months, 1,2,3 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03227757
Study type Interventional
Source Abbott Medical Devices
Contact
Status Active, not recruiting
Phase N/A
Start date August 1, 2017
Completion date June 9, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT06196684 - Early Safety and Clinical Efficacy of Mitral Allograft in Tricuspid Surgery
Not yet recruiting NCT03278418 - Echo-Guided Tricuspid Valve Surgery Vs. Conservative Approach N/A
Terminated NCT03632967 - Early Feasibility Study of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System N/A
Active, not recruiting NCT05724225 - "Atriogenic Tricuspid Selected, Omics Profile, Multimodality Imaging and Clinical Outcomes"
Completed NCT02981953 - TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System N/A
Completed NCT01444222 - Behaviour of Tricuspid Valve Regurgitation in Volume and/or Pressure Loaded Right Heart
Recruiting NCT04653428 - German Registry for Transcatheter Tricuspid Valve Interventions
Recruiting NCT02574650 - Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) Also Known as TriAlign™. N/A
Completed NCT04945005 - Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation Registry
Recruiting NCT03225612 - Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) N/A
Completed NCT01585779 - Contour 3D®/TriAd® Tricuspid Annuloplasty Ring Post-Market Clinical Trial N/A
Withdrawn NCT03166488 - MRE Evaluation of Liver Stiffness After Tricuspid Valvular Repair N/A
Completed NCT03604484 - Prophylactic Tricuspid Annuloplasty During Mitral Valve Surgery N/A
Completed NCT01537458 - Long-term Outcome After Isolated Tricuspid Valve Repair
Recruiting NCT05913908 - EFS of the DUO System for Tricuspid Regurgitation (TANDEM II) N/A
Recruiting NCT04436653 - THE TRAVEL TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve N/A
Completed NCT01334801 - Biomarkers in Aortic Stenosis - B.A.S.S.
Recruiting NCT04735003 - Transcatheter Interventions for Tricuspid Insufficiency in Italy
Recruiting NCT02314897 - Left Ventricular Pacing to Prevent Iatrogenic TR Pilot Study N/A
Completed NCT01532921 - EASE TRICUSPID Expertise-based Assessment Study on Clinical Efficacy of Contour 3D® in TRICUSPID Valve Annuloplasty