An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated with the Abbott TriClip™ Device (bRIGHT)
bRIGHT
1 other identifier
observational
511
8 countries
26
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2020
Longer than P75 for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2020
CompletedFirst Posted
Study publicly available on registry
July 23, 2020
CompletedStudy Start
First participant enrolled
August 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
January 8, 2025
January 1, 2025
7.3 years
July 16, 2020
January 7, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
up to 30 days
Secondary Outcomes (1)
Composite endpoint of all-cause mortality or TR re-intervention
at 1 year follow-up
Interventions
Transcatheter treatment of TR with Abbott TriClip™.
Eligibility Criteria
All subjects who have symptomatic severe tricuspid regurgitation despite medical therapy and are eligible to receive the TriClip™ per the current approved Indications For Use.
You may qualify if:
- Subjects (\>=18 years age) have severe tricuspid regurgitation and are symptomatic despite medical therapy.
- Subjects eligible to receive the TriClip™ per the current approved Indications for Use.
- Subject must provide written informed consent prior to study procedure.
You may not qualify if:
- \. Subjects participating in another clinical study that may impact the follow-up or results of this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Universitätsklinik Graz
Graz, Austria
Odense University Hospital
Odense, Denmark
University Hospital Bonn
Bonn, North Rhine-Westphalia, 53127, Germany
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
Mainz, Rhineland-Palatinate, 55131, Germany
Leipzig Heart Center
Leipzig, Saxony, 04289, Germany
Zentralklinik Bad Berka GmbH
Bad Berka, Germany
Herz-und Diabetes Zentrum NRW
Bad Oeynhausen, Germany
Schüchtermann-Schiller´sche Kliniken GmbH & Co. KG
Bad Rothenfelde, Germany
DRK Kliniken Köpenick
Berlin, Germany
St.-Johannes-Hospital
Dortmund, Germany
Elisabeth-Krankenhaus Essen GmbH
Essen, Germany
Katholisches Marienkrankenhaus GmbH
Hamburg, Germany
UKE Hamburg (Universitatsklinik Eppendorf)
Hamburg, Germany
Otto-von-Guericke-Universität Magdeburg
Magdeburg, Germany
Robert-Bosch-Krankenhaus
Stuttgart, Germany
Universitätsklinikum Ulm
Ulm, Germany
Maria Cecilia Hospital
Cotignola, Italy
Azienda Ospedaliera Monaldi
Napoli, Italy
Universita degli Studi di Padova
Padua, Italy
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Centro Hospitalar Vila Nova de Gaia
Porto, Portugal
Hospital de Sant Pau
Barcelona, Barcelona, 08025, Spain
Clinical and Provincial Hospital of Barcelona
Barcelona, Barcelona, 08036, Spain
Hospital Álvaro Cunqueiro
Vigo, Spain
HerzKlinik Hirslanden - Klinik Hirslanden
Zurich, Canton of Zurich, 8032, Switzerland
Inselspital Bern
Bern, 3010, Switzerland
Related Publications (2)
Lurz P, Rommel KP, Schmitz T, Bekeredjian R, Nickenig G, Mollmann H, von Bardeleben RS, Schmeisser A, Atmowihardjo I, Estevez-Loureiro R, Lubos E, Heitkemper M, Peterman K, Lapp H, Donal E. Real-World 1-Year Results of Tricuspid Edge-to-Edge Repair From the bRIGHT Study. J Am Coll Cardiol. 2024 Aug 13;84(7):607-616. doi: 10.1016/j.jacc.2024.05.006. Epub 2024 May 15.
PMID: 38759905DERIVEDLurz P, Besler C, Schmitz T, Bekeredjian R, Nickenig G, Mollmann H, von Bardeleben RS, Schmeisser A, Atmowihardjo I, Estevez-Loureiro R, Lubos E, Heitkemper M, Huang D, Lapp H, Donal E; bRIGHT PAS Principal Investigators. Short-Term Outcomes of Tricuspid Edge-to-Edge Repair in Clinical Practice. J Am Coll Cardiol. 2023 Jul 25;82(4):281-291. doi: 10.1016/j.jacc.2023.05.008. Epub 2023 May 17.
PMID: 37207923DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Meghan Griffin
Clinical Program Director
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2020
First Posted
July 23, 2020
Study Start
August 27, 2020
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
January 1, 2028
Last Updated
January 8, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share