Evaluating the Cardiovalve TR Replacement System for heart valve issues
Safety and Performance of the Cardiovalve TR Replacement System for Tricuspid Regurgitation
This study is testing a new heart valve replacement system to see if it helps people with serious tricuspid regurgitation feel better and stay safe.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Cardiovalve Ltd. Industry-sponsored |
| Locations | 7 sites (Bad Oeynhausen and 6 other locations) |
| Trial ID | NCT05486832 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and performance of the Cardiovalve Tricuspid Valve Replacement System in patients with significant tricuspid regurgitation. It is a multi-center, prospective, single-arm study that will involve multiple hospitals to gather comprehensive data on the device's effectiveness. Participants will receive the Cardiovalve TR system, and their outcomes will be monitored to determine the device's safety profile and overall performance in treating their condition.
Who should consider this trial
Good fit: Ideal candidates include patients with functional tricuspid regurgitation of grade 3 or higher who are symptomatic and classified as NYHA Class II-IVa.
Not a fit: Patients with unsuitable cardiac anatomy, hemodynamic instability, severe right ventricular failure, or those requiring advanced heart failure interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this could provide a new treatment option for patients suffering from severe tricuspid regurgitation.
How similar studies have performed: While this approach is relatively novel, similar studies evaluating new heart valve technologies have shown promising results in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Functional TR ≥3+ * Symptomatic, NYHA Class II-IVa * Patient approved by the Subject Screening Committee Exclusion Criteria: * Cardiac anatomy deemed not suitable for the Cardiovalve TR system * Hemodynamic instability * Severe right ventricular failure * Refractory heart failure requiring advanced intervention
Where this trial is running
Bad Oeynhausen and 6 other locations
- Universität Bochum — Bad Oeynhausen, Germany (Recruiting)
- Charité university — Berlin, Germany (Recruiting)
- Uniklinik Bonn — Bonn, Germany (Recruiting)
- Universitäres Herz — Hamburg, Germany (Recruiting)
- Herzzentrum Uniklinik — Köln, Germany (Recruiting)
- University Heart Center Lübeck — Lübeck, Germany (Recruiting)
- Universitätsklinikum - Regensburg — Regensburg, Germany (Recruiting)
Study contacts
- Study coordinator: Nitza Shoham, PhD
- Email: nitza@cardiovalve.com
- Phone: +972546882988
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.