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

Summary

Participation Requirements

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: This study aims to ...

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: This study aims to assess the influence of FEops HEARTguide 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: Cohort A patients with the following complex anatomy are included: BAV (Sievers 0 or 1) or functional bicuspid aortic valves, severely calcified aortic valve and small aortic roots. Cohort B consecutive patients eligible for TAVI with Acurate TM and Lotus Edge TM valve Study Procedure: Participating sites identifies cases and decide if the patient is eligible for cohort A or B. The pre-procedural CT-scan will be uploaded to FEops HEARTguide. Heart Team decision 1 is according to the clinical routine, including valve type and size, pre-dilatation, post-dilatation, preferred implantation depth and comfort scale level. Heart Team decision 2 is after the simulation of FEops HEARTguide for the final pre-procedural planning. For Cohort A, FEops HEARTguide will give their information about sizing and implantation depth. For Cohort B, FEops HEARTguide will give two simulations, one with an Acurate valve and one with a Lotus Edge valve. The operator will make the final decision about the valve selection. After the procedure the implanted device, size and depth are recorded as standard of care. The follow-up period will be 30 days. A new CT-scan is recommended. However, this will not be mandatory for this study.

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