Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2026-01-01 @ 8:26 AM
Study NCT ID:
NCT05225935
Status:
COMPLETED
Last Update Posted:
2025-06-17
First Post:
2022-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017180', 'term': 'Tachycardia, Ventricular'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-12', 'studyFirstSubmitDate': '2022-01-25', 'studyFirstSubmitQcDate': '2022-02-04', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedure duration', 'timeFrame': 'Day 1', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Number of VT', 'timeFrame': 'Baseline, Month 6, , Month 12', 'description': 'Number of VT'}, {'measure': 'Appropriate antitachycardia pacing from ICD >14 days after procedure', 'timeFrame': 'Month 1, Month 6, Month 12', 'description': 'Number of appropriate antitachycardia pacing from ICD \\>14 days after procedure. for ventricular arrhythmia'}, {'measure': 'Appropriate ICD shock >14 days after procedure', 'timeFrame': 'Month 1, Month 6, Month 12', 'description': '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'}, {'measure': 'Inappropriate ICD shock >14 days after procedure', 'timeFrame': 'Month 1, Month 6, Month 12', 'description': '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'}, {'measure': 'Electrical storm >14 days after procedure', 'timeFrame': 'Month 1, Month 6, Month 12', 'description': 'Number of electrical storm \\>14 days after procedure. Electrical storm is defined as 3 episodes of sustained VT/VF within 24 hours'}, {'measure': 'Sustained VT not treated by ICD >14 days after procedure', 'timeFrame': 'Month 1, Month 6, Month 12', 'description': 'Number of sustained VT not treated by ICD \\>14 days after procedure'}, {'measure': 'anti-arrhythmic drugs', 'timeFrame': 'Month 1, Month 6, Month 12', 'description': 'Use of anti-arrhythmic drugs \\>30 days after procedure'}, {'measure': 'Death', 'timeFrame': 'Month 12', 'description': 'Death'}, {'measure': 'General health-related quality of life', 'timeFrame': 'Baseline, Month 1, Month 6, Month 12', 'description': "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'."}, {'measure': 'Radiofrequency (RF) applications', 'timeFrame': 'Day 1', 'description': 'Proportion of Radiofrequency (RF) applications within isthmii identified by CT-Scan vs outside isthmii'}, {'measure': 'Societal healthcare costs', 'timeFrame': 'Month 1, Month 3, Month 6, Month 9, Month 12', 'description': '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'}, {'measure': 'Payer healthcare costs', 'timeFrame': 'Month 1, Month 3, Month 6, Month 9, Month 12', 'description': "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"}, {'measure': 'Quality-adjusted life', 'timeFrame': 'Month 1, Month 3, Month 6, Month 9, Month 12', 'description': 'Number of (quality-adjusted life-QALY) years: Cumulative over 12 months with EQ-5D-5L measured according to the time frame indicated down below'}, {'measure': 'Incremental cost per QALY gained', 'timeFrame': 'Month 1, Month 3, Month 6, Month 9, Month 12', 'description': 'Incremental cost per QALY gained (ratio): 12-month cumulative costs divided by 12-month cumulative QALYs'}, {'measure': 'Incremental cost per VT episode avoided', 'timeFrame': 'Month 1, Month 3, Month 6, Month 9, Month 12', 'description': 'Incremental cost per VT episode avoided (ratio): 12-month cumulative costs divided by cumulative number of VT in 12-months'}, {'measure': 'Incremental cost per additional day without a VT episode', 'timeFrame': 'Month 1, Month 3, Month 6, Month 9, Month 12', 'description': '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'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myocardial infarction', 'Ventricular Tachycardia', 'Catheter Ablation', 'Imaging', 'Cardiac computed tomography'], 'conditions': ['Ventricular Tachycardia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nAblation 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.\n\nThis 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.\n\nPrimary endpoint will be procedure duration. Secondary endpoints will compare efficacy and safety of both strategies as well as cost-effectiveness.\n\nExpected results are a reduction procedure duration, without alteration of the efficacy for the CT-guided procedure with an improved medico-economic evaluation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years,\n* Indication for catheter ablation intervention with planned preoperative cardiac CT scan\n* 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),\n* Presence of an implantable cardioverter defibrillator, or planned ID implantation before discharge, and\n* One of the following monomorphic VT events within last 6 months:\n\n * A: ≥3 episodes of VT treated with antitachycardia pacing (ATP),\n * B: ≥1 appropriate ICD shocks,\n * C: sustained VT below detection rate of the ICD documented by ECG or any cardiac monitor\n * D: Sustained VT recorded on 12 leads ECG in the absence of ICD\n* Highly effective contraception for women of childbearing potential, maintained during research procedures\n* Signed informed consent ,\n* Affiliated to or beneficiary of a health insurance\n\nExclusion Criteria:\n\n* Unable to understand the nature, risks, significance and implications of the clinical investigation or unwilling to provide written informed consent,\n* 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,\n* Are known to have protruding left ventricular thrombus or mechanical aortic and mitral valves,\n* Have had a prior catheter ablation procedure for VT,\n* Presenting arrhythmia: polymorphic VT or ventricular fibrillation (VF),\n* 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,\n* Women who are pregnant, lactating, or who are planning to become pregnant during the anticipated study period,\n* Patient under legal protection'}, 'identificationModule': {'nctId': 'NCT05225935', 'acronym': 'InEurHeart', 'briefTitle': 'Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia (InEurHeart Study)', 'orgStudyIdInfo': {'id': 'CHUBX 2021/61'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'image-guided VT ablation strategy', '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', 'interventionNames': ['Device: image-guided VT ablation strategy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional VT ablation strategy', 'description': "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.", 'interventionNames': ['Device: conventional VT ablation strategy']}], 'interventions': [{'name': 'image-guided VT ablation strategy', 'type': 'DEVICE', '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', 'armGroupLabels': ['image-guided VT ablation strategy']}, {'name': 'conventional VT ablation strategy', 'type': 'DEVICE', 'description': "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.", 'armGroupLabels': ['conventional VT ablation strategy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Graz', 'country': 'Austria', 'facility': 'Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'city': 'Linz', 'country': 'Austria', 'facility': 'Public Hospital Elisabethinen Linz', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Limoges', 'country': 'France', 'facility': 'CHU de Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Paris', 'country': 'France', 'facility': 'APHP Salpétrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Pessac', 'country': 'France', 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'CHU de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '23538', 'city': 'Lübeck', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'Universitätsklinikum Schleswig-Holstein', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'city': 'Bad Neustadt an der Saale', 'country': 'Germany', 'facility': 'Rhön-Klinikum AG', 'geoPoint': {'lat': 50.32174, 'lon': 10.20673}}, {'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Evangelisches Krankenhaus Düsseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Asklepios Klinik St. Georg Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'München', 'country': 'Germany', 'facility': 'Deutsches Herzzentrum München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselspital, Universitätsspital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Vaudois University Hospital, Lausanne', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Frederic Sacher, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'collaborators': [{'name': 'EIT Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}