Clinical trial Recruiting at 1 site Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment2000 (estimated)
SponsorUniversity of Luebeck
Academic / other
Locations1 site (Lübeck, Schleswig-Holstein)
StatusRecruiting
StartedJanuary 1, 2025
Main results expectedDecember 1, 2030
Study endsDecember 30, 2030
Registry record updatedFebruary 3, 2025
Trial IDNCT06804148 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.