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New treatment option for Aortic Valve Stenosis
Official title LANDMARK Trial: a Randomised Controlled Trial of Myval THV
ClinicalTrials.gov ID: NCT04275726
What this study is testing
- What it's testing
- The primary objective of this study (LANDMARK) is to compare the safety and effectiveness of the Myval THV Series with Contemporary Valves (Sapien THV Series and Evolut THV Series) in patients with severe symptomatic native aortic valve stenosis. This study will be done in total 768 subjects (384:384, Myval THV Series vs.
- 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 18 and older
You may be able to join if
- Patient ≥18 years of age.
- Patient or their legal representative has provided written informed consent as approved by the Institutional Review Board (IRB)/Institutional Ethics...
- As per local Heart Team assessment, patient is eligible for TAVI and the patient is suitable for implantation with all three study devices.
You likely can't join if
- Patients who are not willing to provide informed consent form, or whose legal heirs object to their participation in the study.
- Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Minsk, Belarus
- São Paulo, Brazil
- Split, Croatia
- Zagreb, Croatia
- Tallinn, Estonia
- Créteil, France
- Lille, France
- Massy, France
- Nice, France
- Rennes, France
- Bad Nauheim, Hesse, Germany
- Leipzig, Saxony, Germany
- Bad Krozingen, Germany
- Braunschweig, Germany
- Dresden, Germany
- Hamburg, Germany
- Regensburg, Germany
- Athens, Greece
- Marousi, Greece
- Thessaloniki, Greece
+ 31 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minsk, Belarus; São Paulo, Brazil; Split, Croatia; Zagreb, Croatia; Tallinn, Estonia; Créteil, France and 45 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.