MYVAL Transcatheter Heart Valve System - Prospective German Multicenter Registry

Prof. Dr. med. Ingo Eitel2,000 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

2,000

Conditions

Aortic Valve Stenosis

Interventions

Myval Transcatheter Heart ValveDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Universitätsklinikum Schleswig-Holstein - Campus Lübeck

Lübeck, Schleswig-Holstein, Germany

RECRUITING

Outcomes

Primary Outcomes

It is a composite of: - All-cause mortality - All stroke - Moderate or severe paravalvular regurgitation

Time frame: 5 Year

Central Contacts

Ingo Eitel, Prof. Dr.

CONTACT

004945150044542 cvro@uksh.de

Christian Frerker, PD Dr.

CONTACT

Data from ClinicalTrials.gov

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