NL-OMON56189RecruitingNot Applicable
Preoperative CT-imaging with patient-specific computer simulation in transcatheter aortic valve replacement: a randomized controlled trial. - GUIDE-TAVR
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Sint Antonius Ziekenhuis
- Enrollment
- 354
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •- Primary symptomatic severe aortic valve stenosis (defined as an aortic valve
- •area of <1.0cm2 and either a mean valve gradient of at least 40mmHg or a peak
- •velocity of at least 4.0 m/s)
- •- Accepted for TAVR, either by transfemoral, transsubclavian or transapical
- •access as determined by the Heart Team and additionally the dedicated TAVR-team.
- •- Plan to implant one of the following TAVR heart valves for which FEops
- •HEARTguide* is available:
- •o CoreValve*, Evolut* R, and Evolut* PRO and Evolut* PRO+ valves (Medtronic)
- •o ACURATE neo* Aortic Valve System (Boston Scientific) (ACURATE neo 2* will be
- •available for FHG later this year)
- •- Informed consent
Exclusion Criteria
- •- Previous surgical aortic valve replacement
- •- Permanent pacemaker at baseline
- •- Emergency procedure
- •- Poor CT image quality (disabling computer-simulation), 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
Investigators
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