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

January 27, 2025 updated by: Prof. Dr. med. Ingo Eitel
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ingo Eitel, Prof. Dr.
  • Phone Number: 004945150044542
  • Email: cvro@uksh.de

Study Contact Backup

  • Name: Christian Frerker, PD Dr.

Study Locations

  • Germany
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein - Campus Lübeck
        • Contact:
          • Christian Frerker, PD Dr.
          • Phone Number: 045150044542
          • Email: CVRO@uksh.de

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who will be treated with Myval TAVR are included in the registry.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
It is a composite of: - All-cause mortality - All stroke - Moderate or severe paravalvular regurgitation
Time Frame: 5 Year
5 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. med. Ingo Eitel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 30, 2030

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

January 27, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 27, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-500

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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