MYVAL Transcatheter Heart Valve System - Prospective German Multicenter Registry

NCT ID: NCT06804148

Last Updated: 2025-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2030-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Aortic Valve Stenosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prof. Dr. med. Ingo Eitel

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. med. Ingo Eitel

Head of department of medical clinic II

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Universitätsklinikum Schleswig-Holstein - Campus Lübeck

Lübeck, Schleswig-Holstein, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Ingo Eitel, Prof. Dr.

Role: CONTACT

004945150044542

Christian Frerker, PD Dr.

Role: CONTACT

Facility Contacts

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Christian Frerker, PD Dr.

Role: primary

045150044542

Other Identifiers

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2024-500

Identifier Type: -

Identifier Source: org_study_id

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