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 the UK / NCT06569602
Recruiting Observational

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

NCT06569602 · tracked via the Priya Life Science UK tracker
Sponsor
Edwards Lifesciences
Phase
Observational
Started
2024-10-01
Last updated
2026-09-04

Condition(s) studied

Tricuspid Valve RegurgitationHeart Valve DiseasesCardiovascular Diseases

Investigational drug(s) / intervention(s)

Transcatheter Tricuspid Valve Replacement

Transcatheter Tricuspid Valve Replacement: Replacement of the tricuspid valve through a transcatheter approach

Study summary

This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. The Local Site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement with the EVOQUE system per the current instructions for use. 2. Patient agrees to attend follow-up assessments. 3. Patients provided written informed consent for participation in the study. Exclusion Criteria: 1. Patient participating in another interventional biologic, drug, or device clinical study that has not met its primary endpoint(s). 2. Any patient considered to be part of a vulnerable population.

Primary outcome measure(s)

  • Tricuspid regurgitation grade — Up to 7 days, 30 days, and 1 year
    Number of patients with optimal TR grade (≤1 on a 0-5 grade scale)
  • Number of patients with major adverse events (MAE rates) — 30 days
    The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days

Trial sites (23)

FacilityCityRegionStatus
Zentralklinik Bad Berka GmbH Bad Berka Germany Recruiting
Kerckhoff-Klinik GmbH Bad Nauheim Bad Nauheim Germany Recruiting
Rhoen-Klinikum Campus - Bad Neustadt Bad Neustadt an der Saale Germany Recruiting
Herz-und Diabeteszentrum NRW Bad Oeynhausen Germany Recruiting
Deutsches Herzzentrum der Charité (DHZC) Berlin Germany Recruiting
Herzzentrum Universitaet Bonn Bonn Germany Recruiting
St. Johannes Hospital Dortmund Dortmund Germany Recruiting
Universitatsklinik Essen Essen Germany Recruiting
Asklepios Klinik St Georg Hamburg Hamburg Germany Recruiting
Universitaetsklinikum Schleswig Holstein Campus Kiel Kiel Germany Recruiting
Leipzig Herzzentrum Leipzig Germany Recruiting
Universitaetsklinikum Schleswig Holstein Campus Lubeck Lübeck Germany Recruiting
Johannes Gutenberg Universitaet Mainz Mainz Germany Recruiting
Deutsches Herzzentrum Muenchen (DHM) Munich Germany Recruiting
Klinikum der Universitaet Muenchen - Grosshadern Munich Germany Recruiting
Universitaetsklinikum Tuebingen Tübingen Germany Recruiting
Universitaetsklinikum Ulm Ulm Germany Active Not Recruiting
Hygeia Hospital - Athens Athens Greece Active Not Recruiting
Centro Cardiologico Monzino Milano Milan Italy Recruiting
Hospital Clinico San Carlos - Madrid Madrid Spain Recruiting
University Hospital Ramon Y Cajal Madrid Madrid Spain Recruiting
Inselspital Bern Switzerland Recruiting
Oxford John Radcliffe Hospital Oxford United Kingdom Recruiting

More Edwards Lifesciences trials in the UK

SAPIEN 3 Ultra System PMCF Active, not recruiting
MiCLASP Post Market Clinical Follow-Up (PMCF) Study Active, not recruiting
Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve Active, not recruiting
The ENCIRCLE Trial Active, not recruiting

Other trials for the same condition

Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension Recruiting
EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease Recruiting
ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation Enrolling by invitation
A Study to See if Lepodisiran Can Reduce Plaque in Coronary Arteries of Adults With Elevated Lp(a) Who Have Had Heart Events or Are at High Risk Recruiting
SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN Active, not 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 NCT06569602 on ClinicalTrials.gov ↗ ← All trials in the UK