Registry to evaluate the Myval Transcatheter Heart Valve System
MYVAL Transcatheter Heart Valve System - Prospective German Multicenter Registry
This study is testing how well the Myval heart valve works for people with aortic valve stenosis in real-life settings across different hospitals in Germany.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Luebeck Academic / other |
| Locations | 1 site (Lübeck, Schleswig-Holstein) |
| Trial ID | NCT06804148 on ClinicalTrials.gov |
What this trial studies
This registry aims to assess the performance of the Myval Transcatheter Heart Valve (THV) in patients with aortic valve stenosis across multiple centers in Germany. It will collect data on the valve's long-term durability and efficacy in a real-world setting, including a diverse patient population. The study will involve patients who are scheduled to receive the Myval THV, ensuring a comprehensive evaluation of its clinical outcomes.
Who should consider this trial
Good fit: Ideal candidates for this registry are adults aged 18 and older who are scheduled to be treated with the Myval THV.
Not a fit: Patients who are pregnant, lactating, or have contraindications to anti-platelet or anticoagulant therapy may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the long-term effectiveness and safety of the Myval THV, potentially improving treatment options for patients with aortic valve stenosis.
How similar studies have performed: Other studies evaluating transcatheter heart valves have shown promising results, indicating that this approach has potential based on previous successes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient is going to be treated with Myval THV * Age ≥ 18 years * Ability to give informed consent Exclusion Criteria: * Pregnant and lactating women * Patients with hyper sensitivity or allergy to aspirin, heparin, clopidogrel, ticlopidine, cobalt, nickel, chromium, molybdenum or any contrast media. * Patients in whom anti-platelet and/or anticoagulant therapy are contra-indicated. * Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the registry
Where this trial is running
Lübeck, Schleswig-Holstein
- Universitätsklinikum Schleswig-Holstein - Campus Lübeck — Lübeck, Schleswig-Holstein, Germany (Recruiting)
Study contacts
- Study coordinator: Ingo Eitel, Prof. Dr.
- Email: cvro@uksh.de
- Phone: 004945150044542
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.