Treatment of Severe Secondary TRIcuspid Regurgitation in Patients With

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Summary

The purpose of this study is to assess the efficacy and safety of implanting an Edwards Sapien XT Valve into the vena cava inferior (VCI; between right atrium and the hepatic vein) on clinical variables, exercise tolerance and well being in patients with severe tricuspid regurgitation and signs of right heart failure.

See also
Status	Clinical Trial	Phase
Completed	`NCT03723239` - TRICUS STUDY - Safety and Efficacy of the TricValve® Device	N/A
Recruiting	`NCT03416166` - International Multisite Transcatheter Tricuspid Valve Therapies Registry	N/A
Completed	`NCT04141137` - TRICUS STUDY Euro - Safety and Efficacy of the TricValve® Device	N/A

NCT number	NCT02387697
Study type	Interventional
Source	Charite University, Berlin, Germany
Contact
Status	Terminated
Phase	Phase 2/Phase 3
Start date	January 2015
Completion date	May 2018

Treatment of Severe Secondary TRIcuspid Regurgitation in Patients With Advance Heart Failure With CAval Vein Implantation of the Edwards Sapien XT VALve (TRICAVAL)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms