Back to results

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

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

NCT ID

NCT05788770

First Posted

March 15, 2023

Last Updated

March 15, 2023

Sponsor

Romy Hegeman

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

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

Studies a U.S. FDA-regulated Device Product

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

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Romy Hegeman, MD

Phone

+31 (0)6 41 71 16 79

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

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

Learn more about this trial

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

We'll reach out to this number within 24 hrs