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Clinical Trials/NL-OMON56189
NL-OMON56189
Recruiting
Not Applicable

Preoperative CT-imaging with patient-specific computer simulation in transcatheter aortic valve replacement: a randomized controlled trial. - GUIDE-TAVR

Sint Antonius Ziekenhuis0 sites354 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

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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