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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™.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter heart valve procedure | Device | Transcatheter treatment of TR with Abbott TriClip™. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 1 year follow-up |
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Inclusion Criteria:
Exclusion Criteria:
1. Subjects participating in another clinical study that may impact the follow-up or results of this study.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Meghan Griffin | Clinical Program Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinik Graz | Graz | Austria | ||||
| Odense University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38759905 | Derived | 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. | |
| 37207923 |
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| 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 | Naples | Italy |
| St. Antonius Ziekenhuis | Nieuwegein | Netherlands |
| Centro Hospitalar Vila Nova de Gaia | Porto | Portugal |
| Hospital de Sant Pau | Barcelona | Barcelona | 08025 | Spain |
| Hospital Clínic de 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 |
| Lurz 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. |
| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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