A prospective, Multicentric, single arm, open label study for treatment of severe symptomatic non- or mild-calcified Aortic Regurgitation in high-risk patients with Myval Transcatheter Aortic Valve rEpLacement System (Myval THV series).
Sponsor
sponsored by
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Study objectives
The objective of this study is to assess the safety and efficacy of the Myval THV series in high-risk participants (based on Heart Team and Investigator’s discretion) with severe symptomatic non- or mild-calcified aortic regurgitation.
Primary endpoints
The primary endpoint is assessed at 30 days according to the VARC-3 criteria defined.
It is a composite of:
- All-cause mortality
- All stroke
- Bleeding (type 3 and 4)
- Major Vascular Complications
- Acute Kidney Injury (stage 3 and 4)
- Surgery/Intervention related to device
- Conduction system disturbances resulting in a new permanent pacemaker implantation
- ≥Moderate Paravalvular Regurgitation
Several additional endpoints will also be assessed according to the VARC-3 criteria, including:
- Technical success (at exit from procedure room)
- Device success (at 30 days)
- Early safety (at 30 days)
Additionally, left ventricular dimensions and valve haemodynamic outcomes will be assessed based on echocardiographic parameters collected at the following time points: baseline, peri-procedural, discharge, 30 days, 1 year, 3 years and 5 years.
CERC Services
- Full Services
Countries
5-7 coutrines in EU and South America
Number of investigational sites
20-25 sites
Number of patients
164 patients to be enrolled
