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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2023-06-30

Brief Summary

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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).

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Detailed Description

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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

Conditions

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Aortic Valve Stenosis Bicuspid Cardiac Valve

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort A

Patients with a challenging anatomy, including bicuspid aortic valve, severely calcified aortic valves or small aortic roots

FEops HEARTguideTM

Intervention Type OTHER

A patient-specific computer simulation that aims to improve the outcomes after TAVI by suggesting THV platform, THV size and implantation depth with the use of the pre-procedural CT-scan.

Cohort B

Consecutive patients eligible for TAVI with ACURATE-NEO2 valve

FEops HEARTguideTM

Intervention Type OTHER

A patient-specific computer simulation that aims to improve the outcomes after TAVI by suggesting THV platform, THV size and implantation depth with the use of the pre-procedural CT-scan.

Interventions

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FEops HEARTguideTM

A patient-specific computer simulation that aims to improve the outcomes after TAVI by suggesting THV platform, THV size and implantation depth with the use of the pre-procedural CT-scan.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Cohort A:

1. Patients with a Bicuspid Aortic Valve (Sievers 0 or 1) or functional Bicuspid Aortic Valve
2. Patients with a severely calcified aortic valve (Agatston score \> 3000 for men, and \> 1600 for women)
3. Patients with small anatomy defined by mean aortic annulus diameter \< 20mm
* Cohort B:

1. every patient accepted for TAVI and eligible for ACURATE-NEO2-valve.