An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated with the Abbott TriClip™ Device (bRIGHT)

Abbott

Status: Active, not recruiting

Conditions: Tricuspid Valve Regurgitation

Treatments: Device: Transcatheter heart valve procedure

Study type: Observational

Funder types: Industry

Identifiers

NCT04483089

ABT-CIP-10317

Details and patient eligibility

About

The bRIGHT EU PAS study is an observational real-world study evaluating severe tricuspid regurgitation patients treated with the Abbott TriClip™ device (bRIGHT EU Post-Approval Study).

Full description

The TriClip™ bRIGHT EU post-approval study (PAS) study is designed to confirm the safety and performance of the TriClip™ device in a contemporary real-world setting. The bRIGHT PAS study is a prospective, single arm, open-label, multi-center, post market registry, conducted to satisfy condition of CE Marking for the TriClip™.

Enrollment: 511 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects (>=18 years age) have severe tricuspid regurgitation and are symptomatic despite medical therapy.
2. Subjects eligible to receive the TriClip™ per the current approved Indications for Use.
3. Subject must provide written informed consent prior to study procedure.

Exclusion criteria

1. Subjects participating in another clinical study that may impact the follow-up or results of this study.