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Recruiting NCT06804148

MYVAL Transcatheter Heart Valve System - Prospective German Multicenter Registry

— Observational Aortic Valve Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Myval Transcatheter Heart Valve.
Who it may be relevant to
Registry conditions: Aortic Valve Stenosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Rational of the Myval THV - Prospective German Multicenter Registry is to evaluate the performance of this relatively new but very promising TAVR valve in a consecutive real-word, all-comers registry and to assess the long-term durability and efficacy of the Myval THV.

Interventions

  • Device Myval Transcatheter Heart Valve
    The Myval TAVR bioprothesis is a balloon-expandable THV developed by Meril Lifesciences, which has novel operator friendly design features to improve deliverability and aid precise deployment.

Primary outcome measures

  • It is a composite of: - All-cause mortality - All stroke - Moderate or severe paravalvular regurgitation [Time frame: 5 Year]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Germany · 1 center
  • Universitätsklinikum Schleswig-Holstein - Campus Lübeck — Lübeck

Identifiers

NCT: NCT06804148 · 2024-500

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗