MYVAL Transcatheter Heart Valve System - Prospective German Multicenter Registry
ConditionAortic Valve Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorProf. Dr. med. Ingo Eitel
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient is going to be treated with Myval THV
Age ≥ 18 years
Ability to give informed consent
Disqualifiers
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
Trial population
Patients who will be treated with Myval TAVR are included in the registry.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Myval Transcatheter Heart Valve
DeviceThe 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
It is a composite of: - All-cause mortality - All stroke - Moderate or severe paravalvular regurgitation
Time frame
5 YearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Prof. Dr. med. Ingo Eitel
Lead sponsor
University of Luebeck
Sponsor institution
Source ClinicalTrials.gov