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Compares treatment options for Symptomatic Severe Aortic Stenosis
Official title Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients
ClinicalTrials.gov ID: NCT06861361
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 to 75
You may be able to join if
- Participant will be included if all the following criteria are met:
- Patients aged ≥65 and ≤75
- Symptomatic severe aortic stenosis (mean gradient≥40mmHg, and or peak velocity\>4m/sec).
- Patients with symptomatic heart disease due to severe native calcific aortic stenosis, as judged by a multidisciplinary heart team (including a...
You likely can't join if
- Participant will not be included if any one of the following conditions exists:
- Unable to understand and follow clinical investigation-related instructions or unable to comply with the clinical investigation protocol
- Life expectancy less than 1 year
- Known hypersensitivity or allergy to aspirin, clopidogrel or any Device frame components.
- Under judicial protection, tutorship, or curatorship
- Participation in another trial before the primary endpoint
The study team makes the final eligibility decision.
Where it's taking place
- Graz, Austria
- Sankt Pölten, Austria
- Vienna, Austria
- Tallinn, Estonia
- Lille, France
- Lyon, France
- Massy, France
- Rouen, France
- Toulouse, France
- Frankfurt, Germany
- Hamburg, Germany
- München, Germany
- Trier, Germany
- Budapest, Hungary
- Debrecen, Hungary
- Szeged, Hungary
- Mercogliano, Italy
- Milan, Italy
- Parma, Italy
- Roma, Italy
+ 23 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Graz, Austria; Sankt Pölten, Austria; Vienna, Austria; Tallinn, Estonia; Lille, France; Lyon, France and 37 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.