Addition of Computer Simulations to Minimize Adverse Events After Transcatheter Aortic Valve Implantation (PRECISE_TAVI)

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    200
  • sponsor
    Erasmus Medical Center
Updated on 4 October 2022
transcatheter aortic valve implantation
tavi

Summary

The objective is to assess the influence of FEops HEARTguide on overall device success in TAVI patients with challenging anatomies (Cohort A) or in transcatheter heart valve (THV) platform selection (Cohort B).

Description

Rationale Transcatheter aortic valve implantation (TAVI) is increasingly used to treat patients with severe aortic stenosis. However, by extending the indication for TAVI, simulation may become increasingly important to improve procedure execution, safety and efficacy.

Objective Assess the influence of FEops HEARTguideTM on overall device success in challenging anatomies (Cohort A) or in transcatheter heart valve (THV) platform selection (Cohort B).

Study design Prospective, observational multi-center trial with 2 cohorts.

Study population

  1. Cohort A: patients with challenging anatomy undergoing EvolutTM TAVI (Medtronic, Minneapolis, Minnesota), to evaluate the influence of FEops HeartGuideTM on overall device success through valve size and implantation depth.
  2. Cohort B: consecutive patients, eligible for TAVI with ACURATE NEO2 TM (Boston Scientific, Marlborough, Massachusetts) to evaluate the influence of FEops heartGuideTM on overall device success and PVL prediction.

Main Endpoints

  1. Overall device success conform VARC-2 including need for new permanent pacemaker. 2. Incidence of > trivial Paravalvular leakage (PVL) 3. Need for new permanent pacemaker

Details
Condition Aortic Valve Stenosis, Bicuspid Cardiac Valve
Treatment FEops HEARTguideTM
Clinical Study IdentifierNCT04473443
SponsorErasmus Medical Center
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Cohort A
Patients with a Bicuspid Aortic Valve (Sievers 0 or 1) or functional Bicuspid Aortic Valve
Patients with a severely calcified aortic valve (Agatston score > 3000 for men, and > 1600 for women)
Patients with small anatomy defined by mean aortic annulus diameter < 20mm
Cohort B
every patient accepted for TAVI and eligible for ACURATE-NEO2-valve

Exclusion Criteria

poor CT quality
previous aortic valve replacement
Permanent pacemaker at baseline
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