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

Study Overview
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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).

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 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. 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

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

Conditions
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Aortic Valve Stenosis, Bicuspid Cardiac Valve

Intervention / Treatment
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* Other: FEops HEARTguideTM


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort A<br>Patients with a challenging anatomy, including bicuspid aortic valve, severely calcified aortic valves or small aortic roots | Other: FEops HEARTguideTM<br>* 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.<br>|
| Cohort B<br>Consecutive patients eligible for TAVI with ACURATE-NEO2 valve | Other: FEops HEARTguideTM<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall device success conform the VARC-2 document | Incidence of mortality incidence of stroke incidence of major vascular complication incidence of life-threatening bleeding | 30 days after TAVI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of more than trivial PVL | total incidence of trivial PVL | 30 days after TAVI | 
| conduction abnormalities and need for new permanent pacemaker implantation | incidence of new permanent pacemaker implantations incidence of left bundle branch block incidence of total AV block | 30 days after TAVI |