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

Primary Purpose

Aortic Valve Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
FEops HEARTGuide
Sponsored by
Romy Hegeman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vienna General Hospital
  • St. Antonius HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

FEops HEARTGuided transcatheter aortic valve implantation

Standard transcatheter aortic valve implantation (no FEops HEARTGuide)

Arm Description

Outcomes

Primary Outcome Measures

Mild to severe paravalvular regurgitation

Secondary Outcome Measures

Incidence of new conduction disorder (new-onset left bundle branch block or new-onset atrioventricular block)
Need for permanent pacemaker implantation
Preoperative valve size selection
Final valve size
Target implantation depth
Final implantation depth
Change of preoperative decision in choice of default transcather heart valve
Change of preoperative decision in valve size selection
Change of preoperative decision in target implantation depth
Failure to implant valve
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
Quality of life assessed by the EuroQol-5 Dimension questionnaire
Quality of life assessed by the Kansas City Cardiomyopathy Questionnaire

Full Information

First Posted
March 15, 2023
Last Updated
March 15, 2023
Sponsor
Romy Hegeman
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05788770
Brief Title
Preoperative CT-imaging With Patient-specific Computer Simulation in Transcatheter Aortic Valve Replacement: a Randomized Controlled Trial
Acronym
GUIDE-TAVI
Official Title
Preoperative CT-imaging With Patient-specific Computer Simulation in Transcatheter Aortic Valve Replacement: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Romy Hegeman
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multicenter, multinational, randomized controlled, open-label, trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
454 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FEops HEARTGuided transcatheter aortic valve implantation
Arm Type
Experimental
Arm Title
Standard transcatheter aortic valve implantation (no FEops HEARTGuide)
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
FEops HEARTGuide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mild to severe paravalvular regurgitation
Time Frame
30-days
Secondary Outcome Measure Information:
Title
Incidence of new conduction disorder (new-onset left bundle branch block or new-onset atrioventricular block)
Time Frame
30 days after TAVI
Title
Need for permanent pacemaker implantation
Time Frame
30 days after TAVI
Title
Preoperative valve size selection
Time Frame
Preprocedural
Title
Final valve size
Time Frame
Perprocedural
Title
Target implantation depth
Time Frame
Preprocedural
Title
Final implantation depth
Time Frame
Perprocedural
Title
Change of preoperative decision in choice of default transcather heart valve
Time Frame
Preprocedural
Title
Change of preoperative decision in valve size selection
Time Frame
Preprocedural
Title
Change of preoperative decision in target implantation depth
Time Frame
Preprocedural
Title
Failure to implant valve
Time Frame
Preprocedural
Title
Composite endpoint of major adverse cardiac and cerebrovascular events (MACCE)
Description
Including mortality, stroke, life-threatening bleeding, major vascular complications, valve-related dysfunction requiring repeat procedure (TAVR or SAVR), according to the VARC-3 criteria
Time Frame
30 days after TAVI
Title
Quality of life assessed by the EuroQol-5 Dimension questionnaire
Time Frame
90 days after TAVI
Title
Quality of life assessed by the Kansas City Cardiomyopathy Questionnaire
Time Frame
90 days after TAVI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Romy Hegeman, MD
Phone
+31 (0)6 41 71 16 79
Email
r.hegeman@antoniusziekenhuis.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Dirk-Jan van Ginkel, MD
Phone
+31 (0) 88 320 66 48
Email
d.van.ginkel@antoniusziekenhuis.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Klein, MD, PhD
Organizational Affiliation
St. Antonius Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Swaans, MD, PhD
Organizational Affiliation
St. Antonius Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Prof. Jurriën ten Berg, MD, PhD
Organizational Affiliation
St. Antonius Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vienna General Hospital
City
Vienna
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof. Martin Andreas, MD, PhD
First Name & Middle Initial & Last Name & Degree
Severin Längle, MD
Facility Name
St. Antonius Hospital
City
Nieuwegein
State/Province
Utrecht
ZIP/Postal Code
3435 CM
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Romy Hegeman, MD
First Name & Middle Initial & Last Name & Degree
Dirk-Jan van Ginkel, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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