Clinical Trial

TRILUMINATE Pivotal Trial

Study Description

TRILUMINATE Pivotal Trial

The primary objective of this trial is to demonstrate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (TriClip device) to Control (Medical Therapy).

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Recruiting patients only Recruiting patients only

Device - Tricuspid valve repair

Transcatheter TriClip placement in the tricuspid valve to repair the valve and correct regurgitation

Additional Information

Official Study Title

Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal

Clinical Trial ID

NCT03904147

ParticipAid ID

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