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

Erasmus Medical Center200 enrolled

Overview

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).

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

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Aortic Valve Stenosis Bicuspid Cardiac Valve

Interventions

FEops HEARTguideTMOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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. Exclusion Criteria: * poor CT quality * previous aortic valve replacement * Permanent pacemaker at baseline

Locations (1)

Erasmus Medical Center

Rotterdam, Netherlands

RECRUITING

Outcomes

Primary Outcomes

overall device success conform the VARC-2 document

* Incidence of mortality * incidence of stroke * incidence of major vascular complication * incidence of life-threatening bleeding

Time frame: 30 days after TAVI

Secondary Outcomes

incidence of more than trivial PVL

total incidence of trivial PVL

Time frame: 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

Time frame: 30 days after TAVI

Central Contacts

Nicolas van Mieghem, MD, PhD

CONTACT

+31107035260 n.vanmieghem@erasmusmc.nl

Thijmen Hokken, MD

CONTACT

+31107038896 t.hokken@erasmusmc.nl

Data from ClinicalTrials.gov

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