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New treatment option for Aortic Stenosis Disease
Official title Optimized Expansion of the Implanted Transcatheter Aortic Valve
ClinicalTrials.gov ID: NCT07042529
What this study is testing
- What it's testing
- Optimized Expansion of the implanted transcatheter aortic valve to reduce hypoattenuating leaflet thickening in non-atrial fibrillation patients undergoing transcatheter aortic valve implantation (TAVI): an international, multicentre, randomized controlled trial. The objective is to evaluate whether TAVI with systematic optimized pre- and post-dilatation (optimized expansion (OptEx) TAVI strategy), compared to a standard of care (SoC) TAVI strategy, is superior in reducing hypoattenuating leaflet thickening as evaluated by cardiac computed tomography (CT) imaging at three months after TAVI.
- 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
- Severe native aortic valve stenosis
- Indication for TAVI
- Ability to understand and to comply with the study protocol
You likely can't join if
- Existing indication for oral anticoagulation (e.g., atrial fibrillation, venous thromboembolism, antiphospholipid syndrome, mechanical mitral valve)
- Creatinine clearance \<15 mL/min (CKD-EPI formula) or on renal replacement therapy
- Iodine contrast allergy or other condition that prohibits cardiac CT imaging
The study team makes the final eligibility decision.
Where it's taking place
- Aalst, Belgium
- Charleroi, Belgium
- Leuven, Belgium
- Roeselare, Belgium
- Aa, Denmark
- Aalborg, Denmark
- Copenhagen, Denmark
- Odense C, Denmark
- Turku, Finland
- Amsterdam, Netherlands
- Groningen, Netherlands
- Leiden, Netherlands
- Nieuwegein, Netherlands
- Haukeland, Norway
- Oslo, Norway
- Gothenburg, Sweden
- Skåne, Sweden
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 Aalst, Belgium; Charleroi, Belgium; Leuven, Belgium; Roeselare, Belgium; Aa, Denmark; Aalborg, Denmark and 11 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.