MYVAL Transcatheter Heart Valve System - Prospective German Multicenter Registry (German MYVAL S)

Prof. Dr. med. Ingo Eitel

Status: Enrolling

Conditions: Aortic Valve Stenosis

Treatments: Device: Myval Transcatheter Heart Valve

Study type: Observational

Funder types: Other

Identifiers

NCT06804148

2024-500

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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