Registry to evaluate the Myval Transcatheter Heart Valve System
Official title: MYVAL Transcatheter Heart Valve System - Prospective German Multicenter Registry
Run by University of Luebeck · NCT06804148 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | University of Luebeck Academic / other |
| Locations | 1 site (Lübeck, Schleswig-Holstein) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | December 1, 2030 |
| Study ends | December 30, 2030 |
| Registry record updated | February 3, 2025 |
| Trial ID | NCT06804148 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this registry are adults aged 18 and older who are scheduled to be treated with the Myval THV.
✕Probably not a fit
Patients who are pregnant, lactating, or have contraindications to anti-platelet or anticoagulant therapy may not benefit from this registry.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies evaluating transcatheter heart valves have shown promising results, indicating that this approach has potential based on previous successes.
Who can join: the full rules
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 it's running
-
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, Schleswig-Holstein, Germany Recruiting
Study contacts
- Study coordinator: Ingo Eitel, Prof. Dr.
- Email: cvro@uksh.de
- Phone: 004945150044542
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.