Ventricular TachycardiaMAP-IN-HEARTNCT04747353
Computed Tomography Targets for Efficient Guidance of Catheter Ablation in Ventricular Tachycardia (MAP-IN-HEART)
A study testing Catheter ablation procedure with heart 3D model in people with Ventricular Tachycardia, run by University Hospital, Bordeaux at 2 sites in 2 countries.
Trial summary
The hypothesis of MAP IN HEART is that catheter ablation for post-infarction ventricular tachycardia (VT) can be largely improved through a direct definition of primary ablation targets from pre-operative CT scan imaging. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- Catheter ablation procedure with heart 3D model
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 4 May 2021to 21 Nov 2022
- 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 to 90 years
- 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)
- and
- One of the following monomorphic VT events within last 6 months:
- A: ≥3 episodes of symptomatic VT treated with antitachycardia pacing (ATP),
Show all 12Show fewer
- B: ≥1 appropriate ICD shocks,
- C: ≥3 VT episodes within 24 hr
- D: sustained VT below detection rate of the ICD documented by ECG or any cardiac monitor
- E: Sustained VT recorded on 12 leads ECG in the absence of ICD
- Signed informed consent
- Affiliated or beneficiary of health insurance
Who cannot join
- Unable 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).
- Are in 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.
Show all 14Show fewer
- Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control. (French HAS criteria or following methods are considered adequate):
- Combined hormonal contraception
- Injected hormonal contraception
- Implanted hormonal contraception
- Progesterone-only hormonal contraception associated with inhibition of ovulation
- Placement of an intrauterine device (IUD)
- Placement of intrauterine hormone-realising system (IUS)
- Patient under legal protection.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
France1 site
Department of Cardiac Pacing and Electrophysiology, CHU Bordeaux
Pessac
About this study
The hypothesis of MAP IN HEART is that catheter ablation for post-infarction ventricular tachycardia (VT) can be largely improved through a direct definition of primary ablation targets from pre-operative CT scan imaging. The objective of is to demonstrate that catheter ablation of post-infarction VT targeting left ventricular wall thickness channels as defined from CT scan is feasible and associated with favorable efficacy, efficiency and safety profiles. A single-arm prospective cohort study will be conducted, including 40 patients over 3 European centres. Baseline, procedural and 6-month follow-up data will be analyzed
Read the detailed description
Background: Although catheter ablation is a recommended therapeutic option in patients with history of myocardial infarction presenting with sustained ventricular tachycardia (VT),1 the current approach relies on lengthy, poorly reproducible and poorly standardized identification of targets derived from invasive catheter measurements. As a consequence, the rate of VT recurrence remains high, leading to repeat interventions.2 Pre-operative CT scan imaging was shown able to identify arrhythmogenic sites within scar through a detailed analysis of left ventricular (LV) wall thickness.3,4 This study aims at demonstrating that using these as primary targets for ablation is a feasible strategy associated with favorable efficacy, efficiency and safety profiles.
Methods: 40 patients with post-infarction VT referred for catheter ablation will be included over 3 European centres. Pre-operative CT scan will be processed to obtain a 3D model of the patient heart comprising detailed anatomy and LV wall thickness maps. Channels of relatively preserved thickness penetrating within severely thinned scar (i.e. CT-channels) will be identified using a proprietary algorithm developed at the IHU LIRYC, University of Bordeaux, and used as primary targets for catheter ablation. During the intervention, the 3D model along with pre-operatively defined targets will be registered in the 3D mapping space, and each CT-channel will be transected by ablation. The inducibility of VT will then be tested and any VT remaining inducible after CT-channels ablation will be targeted using conventional catheter mapping techniques, with a composite procedural endpoint combining the ablation of all CT channels and the non-inducibility of any VT. Procedural and 6-month follow-up data will be analyzed to assess the feasibility of the approach and report its efficiency, efficacy and safety profiles.
Expected results: the CT-guided ablation strategy is expected to be feasible in a vast majority of post-infarction patients referred for VT ablation, and to be extremely time-efficient, the lengthy diagnostic part of the procedure (catheter mapping) being moved pre-operatively (imaging). The short procedure duration should translate into a favorable safety profile. The strategy should also be associated with a high efficacy in eliminating the arrhythmia, thanks to a more comprehensive definition of targets and to the dedication of the procedure time almost entirely to therapy. In conclusion, the present study should provide solid proof of concept on which randomized controlled trials may be built.
- Conditions
- Ventricular Tachycardia
- Being tested
- Catheter ablation procedure with heart 3D model
- 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.
Catheter ablation procedure with heart 3D modelDevice
Device: 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
| Study group | Role | What they receive |
|---|---|---|
| Catheter ablation procedure with heart 3D model | Experimental | 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: Catheter ablation procedure with heart 3D model |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of image-guided VT ablation protocol
Feasibility of the image-guided VT ablation protocol, defined by the presence of all following criteria:
- CT imaging acquisition completed (yes/no)
- pseudonymized images transferred to core lab (yes/no)
- image processing/3D modeling completed by corelab (yes/no)
- 3D model transferred to site within 24h of image acquisition (yes/no)
- 3D model registered in the 3D mapping system during catheter ablation procedure (yes/no)
- all CT-channels targeted by radiofrequency ablation, regardless of local and procedural outcomes (yes/no)
Measured: end of catheter ablation procedure (hour 3)
Secondary outcomes (16)
Rate of acute success after CT-channels ablation
Rate of acute success after CT-channels ablation, defined as non-inducibility of any VT using a prescribed programmed ventricular stimulation protocol.
Measured: end of catheter ablation procedure (hour 3)
Number of VTs persisting after CT channel ablation
Number of VTs persisting after CT channel ablation
Measured: end of catheter ablation procedure (hour 3)
Cycle lengths of VTs persisting after CT channel ablation
Cycle lengths of VTs persisting after CT channel ablation (ms)
Measured: end of catheter ablation procedure (hour 3)
Location of VTs persisting after CT channel ablation
Location of VTs persisting after CT channel ablation with respect to CT channels. Location (critical isthmuses) will be identified using conventional pace mapping or VT/entrainment mapping methods, and described as matching or not matching the location of one CT channel (yes/no/NA)
Measured: end of catheter ablation procedure (hour 3)
Rate of acute success at the end of the procedure
Rate of acute success at the end of the procedure, i.e. after CT-channels ablation and targeting of the potential remaining VTs, defined as non-inducibility of any VT using a prescribed programmed ventricular stimulation protocol.
Measured: end of catheter ablation procedure (hour 3)
Number of VTs persisting at the end of the procedure
Number of VTs persisting at the end of the procedure
Measured: end of catheter ablation procedure (hour 3)
Cycle lengths of VTs persisting at the end of the procedure
Cycle lengths of VTs persisting at the end of the procedure (ms)
Measured: end of catheter ablation procedure (hour 3)
Location of VTs persisting at the end of the procedure
Location of VTs persisting at the end of the procedure with respect to CT channels. Location (critical isthmuses) will be identified using conventional pace mapping or VT/entrainment mapping methods, and described as matching or not matching the location of one CT channel (yes/no/NA)
Measured: end of catheter ablation procedure (hour 3
Rate of VT recurrence at 6-month follow-up
Rate of VT recurrence at 6-month follow-up, defined as at least one appropriate ICD therapy (antitachycardia pacing or shock).
Measured: Month 6
number of sustained VT episodes
Efficacy in reducing VT burden, defined as the number of sustained VT episodes detected by the ICD in the 6 months before vs. 6 months after image-guided VT ablation.
Measured: Baseline, Month 6
Mortality at 6 months follow-up
Mortality at 6 months follow-up
Measured: Month 6
Total procedure duration
Total procedure duration, defined as the total skin-to-skin time
Measured: end of catheter ablation procedure (hour 3)
Procedure duration from start to first radiofrequency ablation
Procedure duration from start to first radiofrequency ablation
Measured: end of catheter ablation procedure (hour 3)
Total radiofrequency ablation time.
Total radiofrequency ablation time.
Measured: end of catheter ablation procedure (hour 3)
Procedure duration from start to completion of CT channels ablation
Procedure duration from start to completion of CT channels ablation.
Measured: end of catheter ablation procedure (hour 3)
Serious adverse effects
Major procedure-related complications, including any complication that is potentially life-threatening or that prolongs hospitalization
Measured: Baseline, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start4 May 2021
- Primary completion21 Nov 2022
- Study completion21 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747353
- Sponsor's protocol ID
- CHUBX 2021/01
- Other IDs
- 2021-A00160-41
- Acronym
- MAP-IN-HEART
- Status last verified
- Apr 2023
- First submitted
- 26 Jan 2021
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computed Tomography Targets for Efficient Guidance of Catheter Ablation in Ventricular Tachycardia (MAP-IN-HEART)
- ClinicalTrials.gov ID
- NCT04747353
- Acronym / sponsor ID
- MAP-IN-HEART / CHUBX 2021/01
- Conditions
- Ventricular Tachycardia
- Keywords
- Myocardial infarction, Ventricular Tachycardia, Catheter Ablation, Imaging, Cardiac computed tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- 4 May 2021 (actual)
- Primary completion
- 21 Nov 2022 (actual)
- Study completion
- 21 Nov 2022 (actual)
- First posted
- 10 Feb 2021 (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.
The hypothesis of MAP IN HEART is that catheter ablation for post-infarction ventricular tachycardia (VT) can be largely improved through a direct definition of primary ablation targets from pre-operative CT scan imaging. The objective of is to demonstrate that catheter ablation of post-infarction VT targeting left ventricular wall thickness channels as defined from CT scan is feasible and associated with favorable efficacy, efficiency and safety profiles. A single-arm prospective cohort study will be conducted, including 40 patients over 3 European centres. Baseline, procedural and 6-month follow-up data will be analyzed
Detailed description
Background: Although catheter ablation is a recommended therapeutic option in patients with history of myocardial infarction presenting with sustained ventricular tachycardia (VT),1 the current approach relies on lengthy, poorly reproducible and poorly standardized identification of targets derived from invasive catheter measurements. As a consequence, the rate of VT recurrence remains high, leading to repeat interventions.2 Pre-operative CT scan imaging was shown able to identify arrhythmogenic sites within scar through a detailed analysis of left ventricular (LV) wall thickness.3,4 This study aims at demonstrating that using these as primary targets for ablation is a feasible strategy associated with favorable efficacy, efficiency and safety profiles.
Methods: 40 patients with post-infarction VT referred for catheter ablation will be included over 3 European centres. Pre-operative CT scan will be processed to obtain a 3D model of the patient heart comprising detailed anatomy and LV wall thickness maps. Channels of relatively preserved thickness penetrating within severely thinned scar (i.e. CT-channels) will be identified using a proprietary algorithm developed at the IHU LIRYC, University of Bordeaux, and used as primary targets for catheter ablation. During the intervention, the 3D model along with pre-operatively defined targets will be registered in the 3D mapping space, and each CT-channel will be transected by ablation. The inducibility of VT will then be tested and any VT remaining inducible after CT-channels ablation will be targeted using conventional catheter mapping techniques, with a composite procedural endpoint combining the ablation of all CT channels and the non-inducibility of any VT. Procedural and 6-month follow-up data will be analyzed to assess the feasibility of the approach and report its efficiency, efficacy and safety profiles.
Expected results: the CT-guided ablation strategy is expected to be feasible in a vast majority of post-infarction patients referred for VT ablation, and to be extremely time-efficient, the lengthy diagnostic part of the procedure (catheter mapping) being moved pre-operatively (imaging). The short procedure duration should translate into a favorable safety profile. The strategy should also be associated with a high efficacy in eliminating the arrhythmia, thanks to a more comprehensive definition of targets and to the dedication of the procedure time almost entirely to therapy. In conclusion, the present study should provide solid proof of concept on which randomized controlled trials may be built.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Catheter ablation procedure with heart 3D model | Experimental | Device: Catheter ablation procedure with heart 3D modelExperimental: 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 |
Who may qualify
- Ages
- 18 to 90 years
- 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)
- and
- One of the following monomorphic VT events within last 6 months:
Key exclusion criteria (14 listed)
- Unable 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 |
|---|---|---|
| Catheter ablation procedure with heart 3D modelDevice: 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 | Device | Catheter ablation procedure with heart 3D model |
Primary outcome
evaluation of image-guided VT ablation protocol
Time frame: end of catheter ablation procedure (hour 3)
Feasibility of the image-guided VT ablation protocol, defined by the presence of all following criteria: * CT imaging acquisition completed (yes/no) * pseudonymized images transferred to core lab (yes/no) * image processing/3D modeling completed by corelab (yes/no) * 3D model transferred to site within 24h of image acquisition (yes/no) * 3D model registered in the 3D mapping system during catheter ablation procedure (yes/no) * all CT-channels targeted by radiofrequency ablation, regardless of local and procedural outcomes (yes/no)
16 secondary outcomes
Rate of acute success after CT-channels ablation
Time frame: end of catheter ablation procedure (hour 3)
Number of VTs persisting after CT channel ablation
Time frame: end of catheter ablation procedure (hour 3)
Cycle lengths of VTs persisting after CT channel ablation
Time frame: end of catheter ablation procedure (hour 3)
Location of VTs persisting after CT channel ablation
Time frame: end of catheter ablation procedure (hour 3)
Rate of acute success at the end of the procedure
Time frame: end of catheter ablation procedure (hour 3)
Number of VTs persisting at the end of the procedure
Time frame: end of catheter ablation procedure (hour 3)
Cycle lengths of VTs persisting at the end of the procedure
Time frame: end of catheter ablation procedure (hour 3)
Location of VTs persisting at the end of the procedure
Time frame: end of catheter ablation procedure (hour 3
Rate of VT recurrence at 6-month follow-up
Time frame: Month 6
number of sustained VT episodes
Time frame: Baseline, Month 6
Mortality at 6 months follow-up
Time frame: Month 6
Total procedure duration
Time frame: end of catheter ablation procedure (hour 3)
Procedure duration from start to first radiofrequency ablation
Time frame: end of catheter ablation procedure (hour 3)
Total radiofrequency ablation time.
Time frame: end of catheter ablation procedure (hour 3)
Procedure duration from start to completion of CT channels ablation
Time frame: end of catheter ablation procedure (hour 3)
Serious adverse effects
Time frame: Baseline, Month 6
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 1 Jun 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter ablation procedure with heart 3D model in people with Ventricular Tachycardia, run by University Hospital, Bordeaux 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 12 inclusion and 14 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 1 Jun 2026. 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 France, 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?
evaluation of image-guided VT ablation protocol (time frame: end of catheter ablation procedure (hour 3)). 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 1 Jun 2026.