Clinical Trials Logo
  1. Home
  2. Heart Valve Disease
  3. NCT03225612

Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) — SCOUT-II  

Heart Valve Disease Clinical Trial

Official title:
Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation

Clinical Trial Summary

The purpose of this study is to assess the safety and performance of the Trialign System for the treatment of symptomatic chronic functional tricuspid regurgitation (FTR) in patients with a minimum of moderate tricuspid regurgitation.

The procedure will be performed with the PTVAS device using a non-surgical percutaneous approach to tricuspid valve repair in patients who have FTR with a minimum of moderate tricuspid regurgitation.

Clinical Trial Description

A prospective, single-arm, multi-center study, enrolling symptomatic patients with chronic functional tricuspid regurgitation. The study will include up to 60 subjects from up to 15 sites in Europe and the United States. Follow-up evaluations will be conducted through 5 years post implantation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03225612
Study type Interventional
Source Mitralign, Inc.
Contact Patricia Keating
Phone 978-863-2445
Email pkeating@mitralign.com
Status Recruiting
Phase N/A
Start date May 22, 2017
Completion date November 2022
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Completed NCT02527629 - Aortic Replacement Using Individualised Regenerative Allografts - ARISE (the "Surveillance")
Completed NCT01426776 - Effect of Heart Valve Replacement on Cheyne-Stokes Respiration N/A
Completed NCT01178710 - Effect of Simvastatin on Cardiac Function N/A
Completed NCT00581399 - A Randomized Multicenter Clinical Study On the High Vacuum Body Cavity Drainage System Following Open Heart Surgery Phase 2
Withdrawn NCT00187304 - ACTION - Anticoagulation Treatment Influence on Post-operative Patients Phase 4
Terminated NCT00700947 - Using Beta Blockers to Treat Mitral Regurgitation Phase 1
Recruiting NCT02574650 - Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) Also Known as TriAlign™. N/A
Recruiting NCT02650388 - Frailty and Cognitive Function Assessment of TAVI Patients Phase 4
Completed NCT01996657 - D-dimer and Oral Anticoagulation Therapy in Patients With Mechanical Valve Replacement N/A
Terminated NCT00598936 - A Prospective Study With a New Device for the Monitoring of Cerebral Oxygenation on Cardiac Surgery Patients Phase 1
Terminated NCT01812174 - On-X Heart Valve - 17mm Aortic and 23mm Mitral N/A
Completed NCT01384643 - Effect of Propofol on Renal Injury in Patients Undergoing Valvular Heart Surgery Phase 4
Completed NCT01558765 - CopenHeartVR - Integrated Rehabilitation of Patients After Heart Valve Surgery Phase 2
Active, not recruiting NCT00291525 - Randomized On-X Anticoagulation Trial N/A
Completed NCT02867930 - Comparative Effects of Dexmedetomidine and Ketofol for Sedation in Patients Undergoing Trans-esophageal Echocardiography Phase 4
Recruiting NCT02478008 - A Clinical Study of the CardiAQ™ TMVI System (Transapical DS) N/A
Completed NCT02790008 - Magnetic Resonance Imaging and Fibrosis
Completed NCT02587039 - An Intervention to Reduce Delirium After Cardiac Surgery N/A
Recruiting NCT01855737 - The Study of Warfarin Maintenance Dose in Chinese Patients Phase 4