Aortic Valve Stenosis
Conditions
Brief summary
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
DEVICEMyval 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.
Sponsors
Prof. Dr. med. Ingo Eitel
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is a composite of: - All-cause mortality - All stroke - Moderate or severe paravalvular regurgitation | 5 Year |
Countries
Germany
Contacts
Primary ContactIngo Eitel, Prof. Dr.
Backup ContactChristian Frerker, PD Dr.
Outcome results
None listed