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

N/AActive Not RecruitingNCT04483089

Abbott Medical Devices511 enrolled

Overview

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).

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™.

Study Type

OBSERVATIONAL

Enrollment

511

Conditions

Tricuspid Valve Regurgitation

Interventions

Transcatheter heart valve procedureDEVICE

Transcatheter treatment of TR with Abbott TriClip™.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (25)

Universitätsklinik Graz

Graz, Austria

Outcomes

Primary Outcomes

Acute Procedural Success (APS)

The primary endpoint is Acute Procedural Success (APS) defined as successful implantation of the TriClip™ device with resulting TR reduction at least 1 grade at discharge (30-day echocardiogram will be used if discharge is unavailable or uninterpretable). Subjects who die or undergo tricuspid valve surgery before discharge are considered to be an APS failure.

Time frame: up to 30 days

Secondary Outcomes

Composite endpoint of all-cause mortality or TR re-intervention

The secondary endpoint is a composite endpoint of all-cause mortality or tricuspid valve re-intervention/re-operation at 1 year.

Time frame: at 1 year follow-up

Data from ClinicalTrials.gov

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