NCT05788770 Preoperative CT-imaging with Patient-specific Computer Simulation in Transcatheter Aortic Valve Replacement
| NCT ID | NCT05788770 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Romy Hegeman |
| Condition | Aortic Valve Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 454 participants |
| Start Date | 2022-04-06 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 454 participants in total. It began in 2022-04-06 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion 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 2™ (Boston Scientific, Marlborough, MA, USA) * Informed consent Exclusion Criteria: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 implanted devices affecting the region of interest * Patient who did not agree to the informed consent and/or refused to participate * Patient unable to understand the informed consent/study
Contact & Investigator
Patrick Klein, MD, PhD
PRINCIPAL INVESTIGATOR
St. Antonius Hospital
Frequently Asked Questions
Who can join the NCT05788770 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Valve Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05788770 currently recruiting?
Yes, NCT05788770 is actively recruiting participants. Contact the research team at r.hegeman@antoniusziekenhuis.nl for enrollment information.
Where is the NCT05788770 trial being conducted?
This trial is being conducted at Vienna, Austria, Nieuwegein, Netherlands.
Who is sponsoring the NCT05788770 clinical trial?
NCT05788770 is sponsored by Romy Hegeman. The principal investigator is Patrick Klein, MD, PhD at St. Antonius Hospital. The trial plans to enroll 454 participants.