ClinicaliQ Trial Snapshot
- Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation — Recruiting • Non-phase study • Cardiology / Cardiovascular • NCT05797519.
- What is being tested: The VDyne Transcatheter Tricuspid Valve Replacement System, a minimally invasive device designed to replace the tricuspid valve in patients with tricuspid regurgitation, with data collection aimed at achieving CE Mark approval.
- Patient eligibility overview: The trial enrolls patients with significant tricuspid regurgitation who are suitable candidates for transcatheter intervention; specific inclusion/exclusion criteria would be detailed in the full protocol but typically target those with symptomatic disease and appropriate anatomical features.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
The purpose of this clinical study is to collect safety and efficacy data of the VDyne System to support Conformitè Europëenne (CE) Mark of the VDyne System.
Eligibility Snapshot
- : 1. Severe or greater tricuspid valve regurgitation of primary or secondary etiology. 2. NYHA class ≥ II. If NYHA Class IV, patient must be ambulatory.
- Subject is adequately treated with medical therapy for heart failure >30 days prior to index procedure, including a diuretic. 4. Heart Team determines patient is a recommended candidate for the VDyne System. 5. Age 18 years or older at time of the index procedure. 6. Clinical Screening Committee (CSC) and Imaging Core Labs confirm suitability for treatment with the VDyne System.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.