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

Erasmus University

Status: Enrolling

Conditions: Aortic Valve Stenosis; Bicuspid Cardiac Valve

Treatments: Other: FEops HEARTguideTM

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04473443

PRECISE TAVI

Details and patient eligibility

About

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).

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

200 participants in 2 patient groups

Cohort A

Description:

Patients with a challenging anatomy, including bicuspid aortic valve, severely calcified aortic valves or small aortic roots

Treatment:

Other: FEops HEARTguideTM

Cohort B

Description:

Consecutive patients eligible for TAVI with ACURATE-NEO2 valve

Treatment:

Other: FEops HEARTguideTM