NCT06804148

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Jan 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Jan 2025Dec 2030

Study Start

First participant enrolled

January 1, 2025

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2030

Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

5.9 years

First QC Date

January 27, 2025

Last Update Submit

January 27, 2025

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

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

    5 Year

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patient is going to be treated with Myval THV
  • Age ≥ 18 years
  • Ability to give informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Schleswig-Holstein - Campus Lübeck

Lübeck, Schleswig-Holstein, 23538, Germany

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Central Study Contacts

Ingo Eitel, Prof. Dr.

CONTACT

004945150044542cvro@uksh.de

Christian Frerker, PD Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of department of medical clinic II

Study Record Dates

First Submitted

January 27, 2025

First Posted

February 3, 2025

Study Start

January 1, 2025

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 30, 2030

Last Updated

February 3, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)