Using Myval heart valves for aortic valve replacement through the armpit
Myval TransAXillary Transcatheter Aortic Valve Replacement Multicenter Clinical Registry
University of Luebeck · NCT06493994
This study is testing if using the Myval heart valve for aortic valve replacement through the armpit is safe and effective for people with aortic valve stenosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Luebeck (other) |
| Locations | 1 site (Lübeck, Schleswig-Holstein) |
| Trial ID | NCT06493994 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the feasibility, procedural success, safety, and potential benefits of the Myval transcatheter heart valve in patients undergoing transaxillary transcatheter aortic valve replacement (TAVR) for aortic valve stenosis. It involves monitoring patients who have received the Myval valve through a minimally invasive approach. The study will collect data on outcomes and experiences to better understand the effectiveness of this technique.
Who should consider this trial
Good fit: Ideal candidates are patients with aortic valve stenosis who are undergoing transaxillary TAVR with the Myval valve and have a BMI under 35.
Not a fit: Patients with a history of coronary artery bypass grafting or those with a life expectancy of less than two years may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and less invasive option for patients with aortic valve stenosis.
How similar studies have performed: Other studies have shown promise with transcatheter aortic valve replacement techniques, suggesting potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient has been treatet transaxillary (TAX) with Myval transcatheter aortic valve replacement * BMI \<35 kg/m2 * Ability to give informed consent Exclusion Criteria: * History of coronary artery bypass graft and a patent left internal mammary artery (LIMA) * Age ≤18 years * Patients presenting with pregnancy * Patients without informed consent * Expected life expectancy \<2 years
Where this trial is running
Lübeck, Schleswig-Holstein
- Universität zu Lübeck — Lübeck, Schleswig-Holstein, Germany (RECRUITING)
Study contacts
- Study coordinator: Ingo Eitel, Prof. Dr.
- Email: ingo.eitel@uksh.de
- Phone: +49451500444501
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.
Conditions: Aortic Valve Stenosis