MedTrace Logo

Prospective Multicenter Study Evaluating Myval TAVR Safety and Effectiveness in High-risk Severe AR

NCT07751965 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2026-08-07

No results posted yet for this study

Summary

Prospective study is designed to evaluate the safety and efficacy of Myval THV series in patients with severe symptomatic non- or mild-calcified aortic regurgitation.

Conditions

  • Aortic Regurgitation
  • Aortic Disease
  • Calcified Aortic Valve

Interventions

DEVICE

Myval THV series

All patients with severe symptomatic non- or mild-calcified aortic regurgitation undergoing TAVR using Myval THV series in high surgical risk based on investigator/Heart team discretion who meet study eligibility criteria.

Sponsors & Collaborators

  • Ceric Sàrl

    lead INDUSTRY

Principal Investigators

  • Ignacio Amat Santos · Hospital Clínico UniversHospital Clínico Universitario de Valladolid, Spain

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-30
Primary Completion
2027-12-30
Completion
2032-03-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07751965 on ClinicalTrials.gov