NCT05788770

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
454

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 29, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2.7 years

First QC Date

March 15, 2023

Last Update Submit

September 17, 2024

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

  • Mild to severe paravalvular regurgitation

    30-days

Secondary Outcomes (13)

  • 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

  • +8 more secondary outcomes

Study Arms (2)

FEops HEARTGuide

EXPERIMENTAL

Device selection using FEops HEARTGuide: 3D anatomical analysis and simulation of transcatheter aortic valve prosthesis prior to procedure based on computed tomography.

Other: FEops HEARTGuide

Standard transcatheter aortic valve implantation (no FEops HEARTGuide)

NO INTERVENTION

Control: standard of care, CT based device selection.

Interventions

FEops HEARTGuideOTHER

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.

FEops HEARTGuide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Vienna General Hospital

Vienna, Austria

RECRUITING

St. Antonius Hospital

Nieuwegein, Utrecht, 3435 CM, Netherlands

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Romy Hegeman, MD

CONTACT

+31 (0)6 41 71 16 79r.hegeman@antoniusziekenhuis.nl

Dirk-Jan van Ginkel, MD

CONTACT

+31 (0) 88 320 66 48d.van.ginkel@antoniusziekenhuis.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Multicenter, multinational, randomized controlled, open-label, trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Coordinator

Study Record Dates

First Submitted

March 15, 2023

First Posted

March 29, 2023

Study Start

April 6, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

NL(1)AU(1)