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

• Conditions: Aortic Valve Stenosis; Bicuspid Cardiac Valve
• Interventions: Other: FEops HEARTguideTM

• Registration Number: NCT04473443
• Lead Sponsor: Erasmus Medical Center

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

Study Timeline

• Study First Submitted: 2020-07-13
• Study First Submitted QC: 2020-07-13
• Study First Posted: 2020-07-16
• Study Start: 2020-08-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-25
• Last Update Posted: 2022-07-27
• Primary Completion: 2023-02-01
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort A	FEops HEARTguideTM	Patients with a challenging anatomy, including bicuspid aortic valve, severely calcified aortic valves or small aortic roots
Cohort B	FEops HEARTguideTM	Consecutive patients eligible for TAVI with ACURATE-NEO2 valve

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands