Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients
Recruiting
N/A
Interventional Study
Symptomatic Severe Aortic Stenosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 65 – 75
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 1,180 (estimated)
- Sponsor
- Ceric Sàrl · Industry
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About This Trial
The study objective is to demonstrate that the clinical outcomes of the Myval balloon-expandable THV series are non-inferior to those of SAVR in patients with symptomatic severe aortic stenosis aged 65 to 75 years.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Participant will be included if all the following criteria are met:
1. Patients aged ≥65 and ≤75
2. Symptomatic severe aortic stenosis (mean gradient≥40mmHg, and or peak velocity\>4m/sec).
3. Patients with symptomatic heart disease due to severe native calcific aortic stenosis,…
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