Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Italy / NCT04483089
Active, not recruiting Observational

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

NCT04483089 · tracked via the Priya Life Science Italy tracker
Sponsor
Abbott Medical Devices
Phase
Observational
Started
2020-08-27
Last updated
2026-05-18

Condition(s) studied

Tricuspid Valve Regurgitation

Investigational drug(s) / intervention(s)

Transcatheter heart valve procedure

Transcatheter heart valve procedure: Transcatheter treatment of TR with Abbott TriClip™.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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.

Trial sites (25)

FacilityCityRegionStatus
Universitätsklinik Graz Graz Austria
Odense University Hospital Odense Denmark
University Hospital Bonn Bonn North Rhine-Westphalia
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz Mainz Rhineland-Palatinate
Leipzig Heart Center Leipzig Saxony
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
Hospital Clínic de Barcelona Barcelona Barcelona
Hospital Álvaro Cunqueiro Vigo Spain
HerzKlinik Hirslanden - Klinik Hirslanden Zurich Canton of Zurich
Inselspital Bern Bern Switzerland

More Abbott Medical Devices trials in Italy

Post-Market Clinical Follow Up Study With Navitor Valve Recruiting
Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation Active, not recruiting
Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study Recruiting
SyncAV Post-Market Trial Active, not recruiting
PARADIGM: Amplatzer Valvular Plug for PVL Closure Active, not recruiting

Other trials for the same condition

Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04483089 on ClinicalTrials.gov ↗ ← All trials in Italy