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

Active, not recruiting

• Conditions: Tricuspid Valve Regurgitation

• Registration Number: NCT04483089
• Lead Sponsor: Abbott Medical Devices

Brief Summary

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).

Detailed 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™.

Study Timeline

• Study First Submitted: 2020-07-16
• Study First Submitted QC: 2020-07-22
• Study First Posted: 2020-07-23
• Study Start: 2020-08-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-08
• Primary Completion: 2027-12-31
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 511

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute Procedural Success (APS)	up to 30 days	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.

Secondary Outcome Measures

Name	Time	Method
Composite endpoint of all-cause mortality or TR re-intervention	at 1 year follow-up	The secondary endpoint is a composite endpoint of all-cause mortality or tricuspid valve re-intervention/re-operation at 1 year.

Trial Locations

Locations (26)

University Hospital Bonn; 🇩🇪 Bonn, North Rhine-Westphalia, Germany

Universitätsklinik Graz; 🇦🇹 Graz, Austria

Odense University Hospital; 🇩🇰 Odense, Denmark

Leipzig Heart Center; 🇩🇪 Leipzig, Saxony, Germany

Zentralklinik Bad Berka GmbH; 🇩🇪 Bad Berka, Germany

Herz-und Diabetes Zentrum NRW; 🇩🇪 Bad Oeynhausen, Germany

Universitatsmedizin der Johannes Gutenberg-Universitat Mainz; 🇩🇪 Mainz, Rhineland-Palatinate, Germany

Schüchtermann-Schiller´sche Kliniken GmbH & Co. KG; 🇩🇪 Bad Rothenfelde, Germany

St.-Johannes-Hospital; 🇩🇪 Dortmund, Germany

Elisabeth-Krankenhaus Essen GmbH; 🇩🇪 Essen, Germany

DRK Kliniken Köpenick; 🇩🇪 Berlin, Germany

Katholisches Marienkrankenhaus GmbH; 🇩🇪 Hamburg, Germany

UKE Hamburg (Universitatsklinik Eppendorf); 🇩🇪 Hamburg, Germany

Universitätsklinikum Ulm; 🇩🇪 Ulm, Germany

Maria Cecilia Hospital; 🇮🇹 Cotignola, Italy

Otto-von-Guericke-Universität Magdeburg; 🇩🇪 Magdeburg, Germany

Robert-Bosch-Krankenhaus; 🇩🇪 Stuttgart, Germany

St. Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

Centro Hospitalar Vila Nova de Gaia; 🇵🇹 Porto, Portugal

Universita degli Studi di Padova; 🇮🇹 Padova, Italy

Azienda Ospedaliera Monaldi; 🇮🇹 Napoli, Italy

Hospital de Sant Pau; 🇪🇸 Barcelona, Spain

Clinical and Provincial Hospital of Barcelona; 🇪🇸 Barcelona, Spain

HerzKlinik Hirslanden - Klinik Hirslanden; 🇨🇭 Zurich, Switzerland

Inselspital Bern; 🇨🇭 Bern, Switzerland

Hospital Álvaro Cunqueiro; 🇪🇸 Vigo, Spain