Myval TransAXillary Transcatheter Aortic Valve Replacement Multicenter Clinical Registry

NCT06493994 · tracked via the Priya Life Science Germany tracker

Sponsor

University of Luebeck

Phase

Observational

Started

2025-01-01

Last updated

2025-01-03

Condition(s) studied

Aortic Valve Stenosis

Investigational drug(s) / intervention(s)

transaxillary (TAX) transcatheter aortic valve replacement

transaxillary (TAX) transcatheter aortic valve replacement: Study goal is to determine the feasibility, procedural success, safety and potential benefit of the Myval transcatheter heart valve (THV) in patients undergone transaxillary (TAX) transcatheter aortic valve replacement (TAVR).

Study summary

Study goal is to determine the feasibility, procedural success, safety and potential benefit of the Myval transcatheter heart valve (THV) in patients undergone transaxillary (TAX) transcatheter aortic valve replacement (TAVR).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patient has been treatet transaxillary (TAX) with Myval transcatheter aortic valve replacement * BMI \<35 kg/m2 * Ability to give informed consent Exclusion Criteria: * History of coronary artery bypass graft and a patent left internal mammary artery (LIMA) * Age ≤18 years * Patients presenting with pregnancy * Patients without informed consent * Expected life expectancy \<2 years

Primary outcome measure(s)

Time until first occurrence — 30 Days
* Stroke including ischemic or hemorrhagic stroke, * Systemic embolism, * Major bleeding (BARC type 3-5), or Cardiovascular or unexplained death

Trial sites (1)

Facility	City	Region	Status
Universität zu Lübeck	Lübeck	Schleswig-Holstein	Recruiting

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Other trials for the same condition

accuRate Evaluation of Benefit With Optimal Medical Treatment With or Without Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis Active, not recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06493994 on ClinicalTrials.gov ↗ ← All trials in Germany