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New treatment option for Aortic Valve Stenosis
Official title Preoperative CT-imaging with Patient-specific Computer Simulation in Transcatheter Aortic Valve Replacement
ClinicalTrials.gov ID: NCT05788770
What this study is testing
- What it's testing
- Combining routine preoperative CT imaging with patient-specific computer modelling predicts the interaction between different sizes of transcatheter aortic valve replacement devices at different implantation depths and the patient's unique anatomy (including post-implantation deformation) allowing preoperative evaluation of the risk for paravalvular leakage and conduction disorders. The objective of this randomized controlled trial is to evaluate whether pre-operative CT-imaging with advanced computer modelling and simulation (FEops HEARTguide™) adequately predicts procedural outcomes in TAVR procedures, whether it leads to changes of preoperative decisions and whether or not this leads to improved outcome in TAVR procedures.
- 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
- Primary symptomatic severe aortic valve stenosis
- Accepted for TAVR, either by transfemoral, transsubclavian or transapical access
- Plan to implant one of the following transcatheter heart valves for which FEops HEARTguide™ is available (CoreValve™ Evolut™ R, and Evolut™ PRO and...
- Informed consent
You likely can't join if
- a potential subject who meets any of the following criteria will be excluded from participation in this study before randomization:
- Previous surgical aortic valve replacement
- Permanent pacemaker at baseline
- Emergency procedure
- Poor CT image quality (disabling computer-simulation, i.e. generation of 3D anatomical models will not be possible with poor CT image quality), for...
- Patient who did not agree to the informed consent and/or refused to participate
See the full eligibility criteria
- Primary symptomatic severe aortic valve stenosis
- Accepted for TAVR, either by transfemoral, transsubclavian or transapical access
- Plan to implant one of the following transcatheter heart valves for which FEops HEARTguide™ is available (CoreValve™ Evolut™ R, and Evolut™ PRO and Evolut™ PRO+ (Medtronic, Minnesota, USA), ACURATE neo™ and ACURATE neo...
- Informed consent
- a potential subject who meets any of the following criteria will be excluded from participation in this study before randomization:
- Previous surgical aortic valve replacement
- Permanent pacemaker at baseline
- Emergency procedure
- Poor CT image quality (disabling computer-simulation, i.e. generation of 3D anatomical models will not be possible with poor CT image quality), for example because of motion artifacts due to the presence of other...
- Patient who did not agree to the informed consent and/or refused to participate
- Patient unable to understand the informed consent/study
The study team makes the final eligibility decision.
Where it's taking place
- Vienna, Austria
- Nieuwegein, Utrecht, Netherlands
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 Vienna, Austria; Nieuwegein, Utrecht, Netherlands. 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.