Using Myval heart valves for aortic valve replacement through the armpit
Official title: Myval TransAXillary Transcatheter Aortic Valve Replacement Multicenter Clinical Registry
Run by University of Luebeck · NCT06493994 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of Luebeck Academic / other |
| Locations | 1 site (Lübeck, Schleswig-Holstein) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | January 30, 2027 |
| Study ends | January 30, 2027 |
| Registry record updated | January 3, 2025 |
| Trial ID | NCT06493994 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promise with transcatheter aortic valve replacement techniques, suggesting potential for success with this approach.
Who can join: the full rules
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 it's running
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Universität zu Lübeck
Lübeck, Schleswig-Holstein, Germany Recruiting
Study contacts
- Study coordinator: Ingo Eitel, Prof. Dr.
- Email: ingo.eitel@uksh.de
- Phone: +49451500444501
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Transcatheter Aortic Valve Replacement Registry for Outcomes and Quality Monitoring
This registry collects information from hospitals about patients undergoing TAVR to see how care and outcomes compare to guidelines and nationwide data.
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Vericiguat to slow calcific aortic valve narrowing
This trial tests whether vericiguat can slow the progression of mild-to-moderate calcific aortic valve stenosis compared with placebo.
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CHATEAU Registry: Real-world outcomes after TAVR
This registry collects real-world data from adults who had TAVR between 2021 and 2025 to see how they do over time and how valve performance holds up.
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Impact of TAVR on kidney function in people with aortic valve disease
This registry tests how trans-catheter aortic valve implantation affects kidney function and the risk of kidney injury in adults with aortic stenosis.
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Hydra THV Transfemoral Valve Implantation in Severe Aortic Stenosis
This registry tests how safely and effectively the Hydra THV works when implanted through the femoral artery in adults with severe symptomatic aortic stenosis.
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How the type of sedation affects recovery after TAVR
This study will test whether three common sedation approaches (propofol, dexmedetomidine, or midazolam with fentanyl) change how people recover on the first day after transfemoral TAVR.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.