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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04473443

Acronym

PRECISE_TAVI

Enrollment

200

Registered

2020-07-16

Start date

2020-08-01

Completion date

2023-06-30

Last updated

2022-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis, Bicuspid Cardiac Valve

Brief 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

Interventions

OTHERFEops 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Contacts

Primary ContactNicolas van Mieghem, MD, PhD

n.vanmieghem@erasmusmc.nl+31107035260

Backup ContactThijmen Hokken, MD

t.hokken@erasmusmc.nl+31107038896

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026