Aortic Valve StenosisGUIDE-TAVINCT05788770
Preoperative CT-imaging with Patient-specific Computer Simulation in Transcatheter Aortic Valve Replacement
A study testing FEops HEARTGuide in people with Aortic Valve Stenosis, run by Romy Hegeman at 2 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- FEops HEARTGuide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 454 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Apr 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Austria1 site, 1 recruiting
- Recruiting
Vienna General Hospital
Vienna
Prof. Martin Andreas, MD, PhD
Severin Längle, MD
Netherlands1 site, 1 recruiting
- Recruiting
St. Antonius Hospital
Nieuwegein, Utrecht, 3435 CM
Romy Hegeman, MD
Dirk-Jan van Ginkel, MD
About this study
Official title: Preoperative CT-imaging with Patient-specific Computer Simulation in Transcatheter Aortic Valve Replacement: a Randomized Controlled Trial
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.
- Conditions
- Aortic Valve Stenosis
- Being tested
- FEops HEARTGuide
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: FEops HEARTGuide |
| Standard transcatheter aortic valve implantation (no FEops HEARTGuide) | No intervention | Control: standard of care, CT based device selection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mild to severe paravalvular regurgitation
Measured: 30-days
Secondary outcomes (13)
Incidence of new conduction disorder (new-onset left bundle branch block or new-onset atrioventricular block)
Measured: 30 days after TAVI
Need for permanent pacemaker implantation
Measured: 30 days after TAVI
Preoperative valve size selection
Measured: Preprocedural
Final valve size
Measured: Perprocedural
Target implantation depth
Measured: Preprocedural
Final implantation depth
Measured: Perprocedural
Change of preoperative decision in choice of default transcather heart valve
Measured: Preprocedural
Change of preoperative decision in valve size selection
Measured: Preprocedural
Change of preoperative decision in target implantation depth
Measured: Preprocedural
Failure to implant valve
Measured: 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
Measured: 30 days after TAVI
Quality of life assessed by the EuroQol questionnaire
EuroQol-5 Dimensions-5 Levels, lower levels refer to better outcomes. Visual analog scale (0-100). Higher scores refer to a better outcome.
Measured: 90 days after TAVI
Quality of life assessed by the Kansas City Cardiomyopathy Questionnaire
All scores are represented on a 0-to-100-point scale. Higher score refers to preferabel outcomes.
Measured: 90 days after TAVI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start6 Apr 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, multinational, randomized controlled, open-label, trial
- Masking
- None (open label)
- Enrolment
- 454 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Romy Hegeman
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor-investigator, Romy Hegeman, St. Antonius Hospital
- Investigators
- Patrick Klein, MD, PhD, Principal investigator, St. Antonius HospitalMartin Swaans, MD, PhD, Principal investigator, St. Antonius HospitalProf. Jurriën ten Berg, MD, PhD, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788770
- Sponsor's protocol ID
- NL77697.100.21
- Acronym
- GUIDE-TAVI
- Status last verified
- Sep 2024
- First submitted
- 15 Mar 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative CT-imaging with Patient-specific Computer Simulation in Transcatheter Aortic Valve Replacement: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05788770
- Acronym / sponsor ID
- GUIDE-TAVI / NL77697.100.21
- Conditions
- Aortic Valve Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 454 participants (estimated)
- Lead sponsor
- Romy HegemanUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, multinational, randomized controlled, open-label, trial
| Arm | Type | Receives |
|---|---|---|
| FEops HEARTGuide | Experimental | Other: FEops HEARTGuideDevice selection using FEops HEARTGuide: 3D anatomical analysis and simulation of transcatheter aortic valve prosthesis prior to procedure based on computed tomography. |
| Standard transcatheter aortic valve implantation (no FEops HEARTGuide) | No intervention | –Control: standard of care, CT based device selection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FEops HEARTGuideFEops 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. | Other | FEops HEARTGuide |
Primary outcome
Mild to severe paravalvular regurgitation
Time frame: 30-days
13 secondary outcomes
Incidence of new conduction disorder (new-onset left bundle branch block or new-onset atrioventricular block)
Time frame: 30 days after TAVI
Need for permanent pacemaker implantation
Time frame: 30 days after TAVI
Preoperative valve size selection
Time frame: Preprocedural
Final valve size
Time frame: Perprocedural
Target implantation depth
Time frame: Preprocedural
Final implantation depth
Time frame: Perprocedural
Change of preoperative decision in choice of default transcather heart valve
Time frame: Preprocedural
Change of preoperative decision in valve size selection
Time frame: Preprocedural
Change of preoperative decision in target implantation depth
Time frame: Preprocedural
Failure to implant valve
Time frame: Preprocedural
Composite endpoint of major adverse cardiac and cerebrovascular events (MACCE)
Time frame: 30 days after TAVI
Quality of life assessed by the EuroQol questionnaire
Time frame: 90 days after TAVI
Quality of life assessed by the Kansas City Cardiomyopathy Questionnaire
Time frame: 90 days after TAVI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Klein, MD, PhD principal investigator
St. Antonius Hospital
Martin Swaans, MD, PhD principal investigator
St. Antonius Hospital
Prof. Jurriën ten Berg, MD, PhD principal investigator
St. Antonius Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FEops HEARTGuide in people with Aortic Valve Stenosis, run by Romy Hegeman at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Romy Hegeman, MD (+31 (0)6 41 71 16 79, r.hegeman@antoniusziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mild to severe paravalvular regurgitation (time frame: 30-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.