An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device (bRIGHT)
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects (>=18 years age) have severe tricuspid regurgitation and are symptomatic despite medical therapy.
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Subjects eligible to receive the TriClip™ per the current approved Indications for Use.
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Subject must provide written informed consent prior to study procedure.
Exclusion Criteria:
- Subjects participating in another clinical study that may impact the follow-up or results of this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universitätsklinik Graz | Graz | Austria | ||
| 2 | Odense University Hospital | Odense | Denmark | ||
| 3 | University Hospital Bonn | Bonn | North Rhine-Westphalia | Germany | 53127 |
| 4 | Universitatsmedizin der Johannes Gutenberg-Universitat Mainz | Mainz | Rhineland-Palatinate | Germany | 55131 |
| 5 | Leipzig Heart Center | Leipzig | Saxony | Germany | 04289 |
| 6 | Zentralklinik Bad Berka GmbH | Bad Berka | Germany | ||
| 7 | Herz-und Diabetes Zentrum NRW | Bad Oeynhausen | Germany | ||
| 8 | Schüchtermann-Schiller´sche Kliniken GmbH & Co. KG | Bad Rothenfelde | Germany | ||
| 9 | DRK Kliniken Köpenick | Berlin | Germany | ||
| 10 | St.-Johannes-Hospital | Dortmund | Germany | ||
| 11 | Elisabeth-Krankenhaus Essen GmbH | Essen | Germany | ||
| 12 | Katholisches Marienkrankenhaus GmbH | Hamburg | Germany | ||
| 13 | UKE Hamburg (Universitatsklinik Eppendorf) | Hamburg | Germany | ||
| 14 | Otto-von-Guericke-Universität Magdeburg | Magdeburg | Germany | ||
| 15 | Robert-Bosch-Krankenhaus | Stuttgart | Germany | ||
| 16 | Universitätsklinikum Ulm | Ulm | Germany | ||
| 17 | Maria Cecilia Hospital | Cotignola | Italy | ||
| 18 | Azienda Ospedaliera Monaldi | Napoli | Italy | ||
| 19 | Universita degli Studi di Padova | Padova | Italy | ||
| 20 | St. Antonius Ziekenhuis | Nieuwegein | Netherlands | ||
| 21 | Centro Hospitalar Vila Nova de Gaia | Porto | Portugal | ||
| 22 | Hospital de Sant Pau | Barcelona | Spain | 08025 | |
| 23 | Clinical and Provincial Hospital of Barcelona | Barcelona | Spain | 08036 | |
| 24 | Hospital Álvaro Cunqueiro | Vigo | Spain | ||
| 25 | Inselspital Bern | Bern | Switzerland | 3010 | |
| 26 | HerzKlinik Hirslanden - Klinik Hirslanden | Zurich | Switzerland | 8032 |
Sponsors and Collaborators
- Abbott Medical Devices
Investigators
- Study Director: Kartik Sundareswaran, Clinical Program Director
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ABT-CIP-10317