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NOT YET RECRUITING
NCT07751965
NA

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

Sponsor: Ceric Sàrl

View on ClinicalTrials.gov

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.

Official title: Prospective, Multicenter, Single-arm, Open-label Study Evaluating the Safety and Effectiveness of the Myval Transcatheter Heart Valve (THV) System in High-risk Patients With Severe Symptomatic Non- or Mildly Calcified Aortic Regurgitation.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

164

Start Date

2026-10-30

Completion Date

2032-03-30

Last Updated

2026-08-07

Healthy Volunteers

No

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.