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

Aortic Valve Stenosis Clinical Trial

— GUIDE-TAVI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05788770
• Other study ID #: NL77697.100.21
• Status: Recruiting
• Phase: N/A
• Start date: April 6, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: St. Antonius Hospital
• Contact: Romy Hegeman, MD
• Phone: +31 (0)6 41 71 16 79
• Email: r.hegeman[@]antoniusziekenhuis.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 454
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

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.

Locations

Country	Name	City	State
Austria	Vienna General Hospital	Vienna
Netherlands	St. Antonius Hospital	Nieuwegein	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
Romy Hegeman	ZonMw: The Netherlands Organisation for Health Research and Development

Countries where clinical trial is conducted

Austria,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mild to severe paravalvular regurgitation		30-days
Secondary	Incidence of new conduction disorder (new-onset left bundle branch block or new-onset atrioventricular block)		30 days after TAVI
Secondary	Need for permanent pacemaker implantation		30 days after TAVI
Secondary	Preoperative valve size selection		Preprocedural
Secondary	Final valve size		Perprocedural
Secondary	Target implantation depth		Preprocedural
Secondary	Final implantation depth		Perprocedural
Secondary	Change of preoperative decision in choice of default transcather heart valve		Preprocedural
Secondary	Change of preoperative decision in valve size selection		Preprocedural
Secondary	Change of preoperative decision in target implantation depth		Preprocedural
Secondary	Failure to implant valve		Preprocedural
Secondary	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
Secondary	Quality of life assessed by the EuroQol-5 Dimension questionnaire		90 days after TAVI
Secondary	Quality of life assessed by the Kansas City Cardiomyopathy Questionnaire		90 days after TAVI