NL-OMON56189
Recruiting
Not Applicable
Preoperative CT-imaging with patient-specific computer simulation in transcatheter aortic valve replacement: a randomized controlled trial. - GUIDE-TAVR
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sint Antonius Ziekenhuis
- Enrollment
- 354
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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)
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
Outcomes
Primary Outcomes
Not specified
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