Ventricular TachycardiaInEurHeartNCT05225935
Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia
A study testing image-guided VT ablation strategy and conventional VT ablation strategy in people with Ventricular Tachycardia, run by University Hospital, Bordeaux at 14 sites in 4 countries.
Trial summary
This double arm randomized study will compare 2 ventricular tachycardia ablation strategies: the standard strategy based on invasive substrate and VT mapping with 3D electro-anatomical system vs a tailored strategy which identifies targets based on pre-procedural CT-scan imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- image-guided VT ablation strategy and conventional VT ablation strategy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 14 sitesin 4 countries
- Study dates
- 29 Jun 2022to 20 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
- Age ≥ 18 years,
- Indication for catheter ablation intervention with planned preoperative cardiac CT scan
- Prior myocardial infarction (using the international definition of MI: Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non- ischemic cause with documentation of prior ischemic injury),
- Presence of an implantable cardioverter defibrillator, or planned ID implantation before discharge, and
- One of the following monomorphic VT events within last 6 months:
- A: ≥3 episodes of VT treated with antitachycardia pacing (ATP),
Show all 12Show fewer
- B: ≥1 appropriate ICD shocks,
- C: sustained VT below detection rate of the ICD documented by ECG or any cardiac monitor
- D: Sustained VT recorded on 12 leads ECG in the absence of ICD
- Highly effective contraception for women of childbearing potential, maintained during research procedures
- Signed informed consent ,
- Affiliated to or beneficiary of a health insurance
Who cannot join
- Unable to understand the nature, risks, significance and implications of the clinical investigation or unwilling to provide written informed consent,
- Active ischemia (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on ECG) or another reversible cause of VT (e.g. drug-induced arrhythmia), had recent acute coronary syndrome within 30 days thought to be due to acute coronary arterial thrombosis, or have CCS functional class IV angina. Note that biomarker level elevation alone after ventricular arrhythmias does not denote acute coronary syndrome or active ischemia,
- Are known to have protruding left ventricular thrombus or mechanical aortic and mitral valves,
- Have had a prior catheter ablation procedure for VT,
- Presenting arrhythmia: polymorphic VT or ventricular fibrillation (VF),
- Renal failure (Creatinine clearance <30 mL/min), have NYHA Functional class IV heart failure, or a systemic illness likely to limit survival to <1 year,
- Women who are pregnant, lactating, or who are planning to become pregnant during the anticipated study period,
- Patient under legal protection
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
France5 sites
CHU de Clermont-Ferrand
Clermont-Ferrand
CHU de Limoges
Limoges
APHP Salpétrière
Paris
CHU de Bordeaux
Pessac
CHU de Toulouse
Toulouse
Germany5 sites
Rhön-Klinikum AG
Bad Neustadt an der Saale
Evangelisches Krankenhaus Düsseldorf
Düsseldorf
Asklepios Klinik St. Georg Hamburg
Hamburg
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538
Deutsches Herzzentrum München
München
Austria2 sites
Medical University of Graz
Graz
Public Hospital Elisabethinen Linz
Linz
Switzerland2 sites
Inselspital, Universitätsspital Bern
Bern
Vaudois University Hospital, Lausanne
Lausanne
About this study
Official title: Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia (InEurHeart Study)
This double arm randomized study will compare 2 ventricular tachycardia ablation strategies: the standard strategy based on invasive substrate and VT mapping with 3D electro-anatomical system vs a tailored strategy which identifies targets based on pre-procedural CT-scan imaging. The primary endpoint will be procedure duration and secondary endpoints will include safety and efficacy criteria as well as medico-economic evaluation.
Read the detailed description
Ventricular tachycardia ablation is a non-drug alternative for patients with recurrent VT and ischemic cardiomyopathy with a class 1 indication in the latest guidelines. However, it is poorly standardised and reserved to expert centres. Proof of concept studies have demonstrated that image-guided VT ablation is feasible, and that it may improve the efficiency of VT ablation.
Ablation strategy no longer relying on intracardiac 2-dimensional surface catheter measurements for target identification, but on 3- dimensional pre-operative images of the myocardium acquired by computed tomography (CT) would shorten the procedure, make it more reproducible and less dependent of the operator's experience without altering efficacy.
This randomized study will compare VT ablation based on substrate/VT isthmus identification via intracardiac catheter vs identification via pre-procedural CT-scan. Ablation will be performed with the same material.
Primary endpoint will be procedure duration. Secondary endpoints will compare efficacy and safety of both strategies as well as cost-effectiveness.
Expected results are a reduction procedure duration, without alteration of the efficacy for the CT-guided procedure with an improved medico-economic evaluation.
- Conditions
- Ventricular Tachycardia
- Being tested
- image-guided VT ablation strategy, conventional VT ablation strategy
- Keywords
- Myocardial infarction, Ventricular Tachycardia, Catheter Ablation, Imaging, Cardiac computed tomography
- Medical subject headings
- Tachycardia, Ventricular, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
image-guided VT ablation strategyDevice
Catheter ablation procedure performed as part of standard care, although with the addition of an image-based 3D heart model including detailed anatomy and primary ablation targets
conventional VT ablation strategyDevice
Catheter ablation will be performed using conventional mapping techniques to identify targets. The ablation strategy will be left to the local investigator's decision, based on the clinical scenario and operator's habits.
| Study group | Role | What they receive |
|---|---|---|
| image-guided VT ablation strategy | Experimental | Catheter ablation procedure performed as part of standard care, although with the addition of an image-based 3D heart model including detailed anatomy and primary ablation targets Receives: Device: image-guided VT ablation strategy |
| conventional VT ablation strategy | Active comparator | Catheter ablation performed using conventional mapping techniques to identify targets. The ablation strategy will be left to the local investigator's decision, based on the clinical scenario and operator's habits. Receives: Device: conventional VT ablation strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure duration
Procedure duration measured from the first introduction of a catheter in the cardiac chamber of interest (mainly left ventricle or epicardial space) to the end of the last radiofrequency application
Measured: Day 1
Secondary outcomes (16)
Number of VT
Number of VT
Measured: Baseline, Month 6, , Month 12
Appropriate antitachycardia pacing from ICD >14 days after procedure
Number of appropriate antitachycardia pacing from ICD >14 days after procedure. for ventricular arrhythmia
Measured: Month 1, Month 6, Month 12
Appropriate ICD shock >14 days after procedure
Number of any appropriate ICD shock >14 days after procedure. The ICD shocks will be automatically recorded through the device logs and transmitted via remote monitoring whenever possible. Appropriate ICD therapies are defined as antitachycardia pacing or shock delivered
Measured: Month 1, Month 6, Month 12
Inappropriate ICD shock >14 days after procedure
Number of any inappropriate ICD shock >14 days after procedure. The ICD shocks will be automatically recorded through the device logs and transmitted via remote monitoring whenever possible. - Inappropriate ICD therapies are defined as antitachycardia pacing or shock delivered for anything but ventricular arrhythmia
Measured: Month 1, Month 6, Month 12
Electrical storm >14 days after procedure
Number of electrical storm >14 days after procedure. Electrical storm is defined as 3 episodes of sustained VT/VF within 24 hours
Measured: Month 1, Month 6, Month 12
Sustained VT not treated by ICD >14 days after procedure
Number of sustained VT not treated by ICD >14 days after procedure
Measured: Month 1, Month 6, Month 12
anti-arrhythmic drugs
Use of anti-arrhythmic drugs >30 days after procedure
Measured: Month 1, Month 6, Month 12
Death
Death
Measured: Month 12
General health-related quality of life
Quality of life using EQ-5D-5L questionnaire: The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Additinonally, the questionnaire records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Measured: Baseline, Month 1, Month 6, Month 12
Radiofrequency (RF) applications
Proportion of Radiofrequency (RF) applications within isthmii identified by CT-Scan vs outside isthmii
Measured: Day 1
Societal healthcare costs
Total one-year healthcare costs from a societal perspective : Cumulative over 12 months with medical consumption, informal care, and absence from work, all measured according to the time frame indicated down below
Measured: Month 1, Month 3, Month 6, Month 9, Month 12
Payer healthcare costs
Total one-year healthcare costs from a payer's perspective: Cumulative over 12 months with medical consumption, measured according to the time frame indicated down below
Measured: Month 1, Month 3, Month 6, Month 9, Month 12
Quality-adjusted life
Number of (quality-adjusted life-QALY) years: Cumulative over 12 months with EQ-5D-5L measured according to the time frame indicated down below
Measured: Month 1, Month 3, Month 6, Month 9, Month 12
Incremental cost per QALY gained
Incremental cost per QALY gained (ratio): 12-month cumulative costs divided by 12-month cumulative QALYs
Measured: Month 1, Month 3, Month 6, Month 9, Month 12
Incremental cost per VT episode avoided
Incremental cost per VT episode avoided (ratio): 12-month cumulative costs divided by cumulative number of VT in 12-months
Measured: Month 1, Month 3, Month 6, Month 9, Month 12
Incremental cost per additional day without a VT episode
Incremental cost per additional day without a VT episode (ratio): 12-month cumulative costs divided by cumulative number of days without VT in 12 months
Measured: Month 1, Month 3, Month 6, Month 9, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start29 Jun 2022
- Primary completion22 Dec 2023
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventricular TachycardiaStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- EIT Health
- Responsible party
- Sponsor
- Investigators
- Frederic Sacher, MD, PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225935
- Sponsor's protocol ID
- CHUBX 2021/61
- Other IDs
- 2022-A00075-38
- Acronym
- InEurHeart
- Status last verified
- Jun 2025
- First submitted
- 25 Jan 2022
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sacher F, Reichlin T, Le Bloa M, Massoulie G, Waintraub X, Maury P, Scherr D, Tixier R, Guy-Moyat B, Duchateau J, Meyer C, Sermesant M, Plant A, Rousset M, Gunawardene MA, Bronnec N, Gandjbakhch E, Sacristan B, Georget A, Ditac G, Azzouz S, Haissaguerre M, Willems S, Derval N, Tilz RR, Hocini M, Deneke T, Pambrun T, Rutten-van Molken M, Purerfellner H, Englert F, Sauer E, Jais P, Benard A, Cochet H. Computed tomography-guided vs conventional catheter ablation for ventricular tachycardia: the InEurHeart trial. Eur Heart J. 2026 Jun 16;47(23):2951-2964. doi: 10.1093/eurheartj/ehag052.
PubMed 41667137
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia (InEurHeart Study)
- ClinicalTrials.gov ID
- NCT05225935
- Acronym / sponsor ID
- InEurHeart / CHUBX 2021/61
- Conditions
- Ventricular Tachycardia
- Keywords
- Myocardial infarction, Ventricular Tachycardia, Catheter Ablation, Imaging, Cardiac computed tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- EIT Health
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 7 Feb 2022 (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.
This double arm randomized study will compare 2 ventricular tachycardia ablation strategies: the standard strategy based on invasive substrate and VT mapping with 3D electro-anatomical system vs a tailored strategy which identifies targets based on pre-procedural CT-scan imaging. The primary endpoint will be procedure duration and secondary endpoints will include safety and efficacy criteria as well as medico-economic evaluation.
Detailed description
Ventricular tachycardia ablation is a non-drug alternative for patients with recurrent VT and ischemic cardiomyopathy with a class 1 indication in the latest guidelines. However, it is poorly standardised and reserved to expert centres. Proof of concept studies have demonstrated that image-guided VT ablation is feasible, and that it may improve the efficiency of VT ablation.
Ablation strategy no longer relying on intracardiac 2-dimensional surface catheter measurements for target identification, but on 3- dimensional pre-operative images of the myocardium acquired by computed tomography (CT) would shorten the procedure, make it more reproducible and less dependent of the operator's experience without altering efficacy.
This randomized study will compare VT ablation based on substrate/VT isthmus identification via intracardiac catheter vs identification via pre-procedural CT-scan. Ablation will be performed with the same material.
Primary endpoint will be procedure duration. Secondary endpoints will compare efficacy and safety of both strategies as well as cost-effectiveness.
Expected results are a reduction procedure duration, without alteration of the efficacy for the CT-guided procedure with an improved medico-economic evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| image-guided VT ablation strategy | Experimental | Device: image-guided VT ablation strategyCatheter ablation procedure performed as part of standard care, although with the addition of an image-based 3D heart model including detailed anatomy and primary ablation targets |
| conventional VT ablation strategy | Active comparator | Device: conventional VT ablation strategyCatheter ablation performed using conventional mapping techniques to identify targets. The ablation strategy will be left to the local investigator's decision, based on the clinical scenario and operator's habits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years,
- Indication for catheter ablation intervention with planned preoperative cardiac CT scan
- Prior myocardial infarction (using the international definition of MI: Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non- ischemic cause with documentation of prior ischemic injury),
- Presence of an implantable cardioverter defibrillator, or planned ID implantation before discharge, and
- One of the following monomorphic VT events within last 6 months:
Key exclusion criteria (8 listed)
- Unable to understand the nature, risks, significance and implications of the clinical investigation or unwilling to provide written informed consent,
- Active ischemia (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on ECG) or another reversible cause of VT (e.g. drug-induced arrhythmia), had recent acute coronary syndrome within 30 days thought to be due to acute coronary arterial thrombosis, or have CCS functional class IV angina. Note that biomarker level elevation alone after ventricular arrhythmias does not denote acute coronary syndrome or active ischemia,
- Are known to have protruding left ventricular thrombus or mechanical aortic and mitral valves,
- Have had a prior catheter ablation procedure for VT,
- Presenting arrhythmia: polymorphic VT or ventricular fibrillation (VF),
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 |
|---|---|---|
| image-guided VT ablation strategyCatheter ablation procedure performed as part of standard care, although with the addition of an image-based 3D heart model including detailed anatomy and primary ablation targets | Device | image-guided VT ablation strategy |
| conventional VT ablation strategyCatheter ablation will be performed using conventional mapping techniques to identify targets. The ablation strategy will be left to the local investigator's decision, based on the clinical scenario and operator's habits. | Device | conventional VT ablation strategy |
Primary outcome
Procedure duration
Time frame: Day 1
Procedure duration measured from the first introduction of a catheter in the cardiac chamber of interest (mainly left ventricle or epicardial space) to the end of the last radiofrequency application
16 secondary outcomes
Number of VT
Time frame: Baseline, Month 6, , Month 12
Appropriate antitachycardia pacing from ICD >14 days after procedure
Time frame: Month 1, Month 6, Month 12
Appropriate ICD shock >14 days after procedure
Time frame: Month 1, Month 6, Month 12
Inappropriate ICD shock >14 days after procedure
Time frame: Month 1, Month 6, Month 12
Electrical storm >14 days after procedure
Time frame: Month 1, Month 6, Month 12
Sustained VT not treated by ICD >14 days after procedure
Time frame: Month 1, Month 6, Month 12
anti-arrhythmic drugs
Time frame: Month 1, Month 6, Month 12
Death
Time frame: Month 12
General health-related quality of life
Time frame: Baseline, Month 1, Month 6, Month 12
Radiofrequency (RF) applications
Time frame: Day 1
Societal healthcare costs
Time frame: Month 1, Month 3, Month 6, Month 9, Month 12
Payer healthcare costs
Time frame: Month 1, Month 3, Month 6, Month 9, Month 12
Quality-adjusted life
Time frame: Month 1, Month 3, Month 6, Month 9, Month 12
Incremental cost per QALY gained
Time frame: Month 1, Month 3, Month 6, Month 9, Month 12
Incremental cost per VT episode avoided
Time frame: Month 1, Month 3, Month 6, Month 9, Month 12
Incremental cost per additional day without a VT episode
Time frame: Month 1, Month 3, Month 6, Month 9, Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Results publication: PubMed 41667137Sacher F, Reichlin T, Le Bloa M, Massoulie G, Waintraub X, Maury P, Scherr D, Tixier R, Guy-Moyat B, Duchateau J, Meyer C, Sermesant M, Plant A, Rousset M, Gunawardene MA, Bronnec N, Gandjbakhch E, Sacristan B, Georget A, Ditac G, Azzouz S, Haissaguerre M, Willems S, Derval N, Tilz RR, Hocini M, Deneke T, Pambrun T, Rutten-van Molken M, Purerfellner H, Englert F, Sauer E, Jais P, Benard A, Cochet H. Computed tomography-guided vs conventional catheter ablation for ventricular tachycardia: the InEurHeart trial. Eur Heart J. 2026 Jun 16;47(23):2951-2964. doi: 10.1093/eurheartj/ehag052.
- 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.
Frederic Sacher, MD, PhD principal investigator
University Hospital, Bordeaux
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing image-guided VT ablation strategy and conventional VT ablation strategy in people with Ventricular Tachycardia, run by University Hospital, Bordeaux at 14 sites in 4 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 12 inclusion and 8 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: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France, Germany, Austria, Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure duration (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05225935, which also lists 1 linked publication.
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 22 May 2026.