Investigation of the EVOQUE System for Tricuspid Valve Replacement
Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Real World European Investigation of Safety and Clinical Efficacy Using a Novel Device
This study is testing a new device for replacing the tricuspid valve in people with heart valve problems to see how safe and effective it is.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Sex | All |
| Sponsor | Edwards Lifesciences Industry-sponsored |
| Locations | 2 sites (Bad Oeynhausen and 1 other locations) |
| Trial ID | NCT06569602 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and clinical efficacy of the Edwards EVOQUE system for transcatheter tricuspid valve replacement in patients with tricuspid valve regurgitation and other heart valve diseases. Up to 500 patients will be enrolled across 45 sites in Europe, with assessments conducted at baseline, post-procedure, and annually for five years. The study will provide real-world data on the device's performance and patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients deemed appropriate for transcatheter tricuspid valve replacement with the EVOQUE system by their local heart team.
Not a fit: Patients participating in other interventional studies or those considered part of a vulnerable population may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment options and outcomes for patients with tricuspid valve regurgitation.
How similar studies have performed: Other studies involving transcatheter heart valve interventions have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bad Oeynhausen and 1 other locations
- Herz-und Diabeteszentrum NRW — Bad Oeynhausen, Germany (Recruiting)
- Inselspital — Bern, Switzerland (Not_yet_recruiting)
Study contacts
- Principal investigator: Volker Rudolph, Prof. MD — Herz-und Diabeteszentrum NRW, Bad Oeynhausen
- Study coordinator: TMTT Clinical
- Email: TMTT_Clinical@Edwards.com
- Phone: +1-949-250-2500 or
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.