NCT04473443

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

Addition of Computer Simulations to the Pre-procedural Planning to Minimize Adverse Events After Transcatheter Aortic Valve Implantation

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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

Conditions

• Aortic Valve Stenosis
• Bicuspid Cardiac Valve

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2020-08-01
• Primary completion: 2023-02-01
• Completion: 2023-06-30
• First posted: 2020-07-16
• Last updated: 2022-07-27

Locations

1 site across 1 country: Netherlands