Preoperative CT-imaging With Patient-specific Computer Simulation in Transcatheter Aortic Valve Replacement: a Randomized Controlled Trial (GUIDE-TAVI)

Combining routine preoperative CT imaging with patient-specific computer modelling predicts the interaction between different sizes of transcatheter aortic valve replacement devices at different implantation depths and the patient's unique anatomy (including post-implantation deformation) allowing preoperative evaluation of the risk for paravalvular leakage and conduction disorders.

The objective of this randomized controlled trial is to evaluate whether pre-operative CT-imaging with advanced computer modelling and simulation (FEops HEARTguide™) adequately predicts procedural outcomes in TAVR procedures, whether it leads to changes of preoperative decisions and whether or not this leads to improved outcome in TAVR procedures.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Other: FEops HEARTGuide

• Study Type: Interventional
• Enrollment (Anticipated): 454
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Romy Hegeman, MD; Phone Number: +31 (0)6 41 71 16 79; Email: r.hegeman@antoniusziekenhuis.nl
• Study Contact Backup: Name: Dirk-Jan van Ginkel, MD; Phone Number: +31 (0) 88 320 66 48; Email: d.van.ginkel@antoniusziekenhuis.nl

Study Locations

• Austria
  • Vienna, Austria
    • Not yet recruiting
    • Vienna General Hospital
    • Contact: Severin Längle, MD
• Netherlands
  • Utrecht
    • Nieuwegein, Utrecht, Netherlands, 3435 CM
      • Recruiting
      • St. Antonius Hospital
      • Contact: Romy Hegeman, MD
      • Contact: Dirk-Jan van Ginkel, MD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Primary symptomatic severe aortic valve stenosis
• Accepted for TAVR, either by transfemoral, transsubclavian or transapical access
• Plan to implant one of the following transcatheter heart valves for which FEops HEARTguide™ is available (CoreValve™ Evolut™ R, and Evolut™ PRO and Evolut™ PRO+ (Medtronic, Minnesota, USA), ACURATE neo™ and ACURATE neo 2™ (Boston Scientific, Marlborough, MA, USA)
• Informed consent

Exclusion Criteria:a potential subject who meets any of the following criteria will be excluded from participation in this study before randomization:

• Previous surgical aortic valve replacement
• Permanent pacemaker at baseline
• Emergency procedure
• Poor CT image quality (disabling computer-simulation, i.e. generation of 3D anatomical models will not be possible with poor CT image quality), for example because of motion artifacts due to the presence of other implanted devices affecting the region of interest
• Patient who did not agree to the informed consent and/or refused to participate
• Patient unable to understand the informed consent/study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FEops HEARTGuided transcatheter aortic valve implantation	Other: FEops HEARTGuide; FEops HEARTGuide added to routine preoperative CT imaging. Results of the computer modelling will be discussed with TAVR implanting team prior to and during the procedure.
No Intervention: Standard transcatheter aortic valve implantation (no FEops HEARTGuide)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mild to severe paravalvular regurgitation	30-days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of new conduction disorder (new-onset left bundle branch block or new-onset atrioventricular block)		30 days after TAVI
Need for permanent pacemaker implantation		30 days after TAVI
Preoperative valve size selection		Preprocedural
Final valve size		Perprocedural
Target implantation depth		Preprocedural
Final implantation depth		Perprocedural
Change of preoperative decision in choice of default transcather heart valve		Preprocedural
Change of preoperative decision in valve size selection		Preprocedural
Change of preoperative decision in target implantation depth		Preprocedural
Failure to implant valve		Preprocedural
Composite endpoint of major adverse cardiac and cerebrovascular events (MACCE)	Including mortality, stroke, life-threatening bleeding, major vascular complications, valve-related dysfunction requiring repeat procedure (TAVR or SAVR), according to the VARC-3 criteria	30 days after TAVI
Quality of life assessed by the EuroQol-5 Dimension questionnaire		90 days after TAVI
Quality of life assessed by the Kansas City Cardiomyopathy Questionnaire		90 days after TAVI

Collaborators and Investigators

• Sponsor: Romy Hegeman
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
• Investigators: Principal Investigator: Patrick Klein, MD, PhD, St. Antonius Hospital; Principal Investigator: Martin Swaans, MD, PhD, St. Antonius Hospital; Principal Investigator: Prof. Jurriën ten Berg, MD, PhD, St. Antonius Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 29, 2023

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 1, 2023

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: NL77697.100.21

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