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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis; Bicuspid Cardiac Valve
• Intervention / Treatment: Other: FEops HEARTguideTM

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Netherlands
  • Rotterdam, Netherlands, 3015GD
    • Recruiting
    • Erasmus Medical Center
    • Contact: Nicolas van Mieghem, MD, PhD; Phone Number: +31(0)107035260; Email: n.vanmieghem@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This prospective multi-center international Registry of TAVI patients include for Cohort A patients with the following complex anatomy: BAV (Sievers 0 or 1) or functional bicuspid aortic valves, severely calcified aortic valve and small aortic roots.

And for Cohort B consecutive patients eligible for TAVI with ACURATE-NEO2-valve

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort A; Patients with a challenging anatomy, including bicuspid aortic valve, severely calcified aortic valves or small aortic roots	Other: FEops 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.
Cohort B; Consecutive patients eligible for TAVI with ACURATE-NEO2 valve	Other: FEops 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Feops
• Investigators: Principal Investigator: Nicolas van Mieghem, Md,PhD, Erasmus Medical Center

Publications and helpful links

General Publications

• Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg. 2013 Jan;145(1):6-23. doi: 10.1016/j.jtcvs.2012.09.002. Epub 2012 Oct 16.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2020
• Primary Completion (ANTICIPATED): February 1, 2023
• Study Completion (ANTICIPATED): June 30, 2023

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (ACTUAL): July 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: PRECISE TAVI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No