Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT07020702
Status:
RECRUITING
Last Update Posted:
2025-07-10
First Post:
2025-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ElectroPhySiological Characterization Of the Arrhythmia Substrate for Sudden Cardiac Death PrEdiction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003643', 'term': 'Death'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2030-09-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-07', 'studyFirstSubmitDate': '2025-06-05', 'studyFirstSubmitQcDate': '2025-06-05', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-09-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of major rhythmic events', 'timeFrame': '60 months', 'description': 'Follow-up on Occurrence of major rhythmic events'}], 'secondaryOutcomes': [{'measure': 'Surfaces distributions of abnormal ventricular potentials', 'timeFrame': 'Day 1'}, {'measure': 'Spatial distributions of abnormal ventricular potentials', 'timeFrame': 'Day 1'}, {'measure': 'Purkinje potentials in induced arrhythmias', 'timeFrame': 'Day 1', 'description': 'Presence or absence'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiomyopathies', 'sudden death', 'Myocardial Infarction'], 'conditions': ['Ventricular Arrhythmia', 'Cardiomyopathies', 'Left Ventricular Ejection Fraction Less Then or Equal to 50percent']}, 'descriptionModule': {'briefSummary': 'EP-SCOPE is a prospective, multicentric, non-randomized pilot study that aims to estimate the risk of life-threatening ventricular arrhythmia through use of advanced electrophysiological studies in patients with ischemic or non-ischemic cardiomyopathy with left ventricular ejection fraction (LVEF) \\<50% and risk factors of ventricular arrhythmia, otherwise not considered for implantation of an implantable cardioverter defibrillator (ICD).\n\nThe objective is to assess the effectiveness of a risk stratification strategy based on detailed electrophysiological exploration of the left ventricle and programmed ventricular stimulation.', 'detailedDescription': 'Responsible for 10% of deaths in the general population, sudden cardiac death is mostly caused by malignant ventricular arrhythmias (80%). These arrhythmias mainly occur in cardiomyopathies (75-90%). Currently, the prevention of sudden death is based on risk stratification according to the evaluation of myocardial contractility with indications for prophylactic ICD implantation reserved for LVEF ≤ 35%. This predictor is notoriously insufficient for several main reasons: 1) While ICDs are indicated in patients with LVEF ≤35%, only a minority (2 -5% per year) will suffer from arrhythmia and therefore benefits from ICD implantation, while all will be subject to potential complications. 2) The majority of sudden death (70-80%) occur in patients with LVEF \\>35%; while they have a lower arrhythmia risk (1-2% per year), they constitute a population four times larger, which is not stratified. 3) Finally, the cardiomyopathy population is broad, and include distinct clinical scenarios that are not specifically addressed.\n\nWhile conventional electrophysiological studies only boast a limited number of measurements, the proposed strategy is a detailed electrophysiological characterization of the altered ventricle. Measurements include a detailed mapping of the left ventricle in the basal state and during extrastimuli, and programmed stimulation of the right and left ventricle including the simultaneous recording of the Purkinje system.\n\nFollow-up will be performed for 3 years, looking for the occurrence of major arrhythmic events such as: 1) Appropriate therapy (for VT/VF) delivered by an ICD or 2) documented ventricular arrhythmia on ECG, implantable loop recorder or pacemaker or 3) Clinical sudden death.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with cardiomyopathy with 35%\\<LVEF\\<50% and at least one risk factor\n* Patients with cardiomyopathy with LVEF≤35% and an indication for cardiac resynchronisation\n\nExclusion Criteria:\n\n* Patients who are minors or aged 80 or over\n* Patients with unstable coronary artery disease\n* Myocardial infarction less than 40 days old\n* Coronary revascularisation \\<90 days\n* Patients with intracardiac thrombus\n* Patients with a mechanical heart valve\n* Patient implanted with an automatic defibrillator\n* Patient life expectancy \\<1 year\n* Pregnant or breast-feeding women\n* Anti-arrhythmic drugs other than beta-blockers and amiodarone'}, 'identificationModule': {'nctId': 'NCT07020702', 'acronym': 'EP-SCOPE', 'briefTitle': 'ElectroPhySiological Characterization Of the Arrhythmia Substrate for Sudden Cardiac Death PrEdiction', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'ElectroPhySiological Characterization Of the Arrhythmia Substrate for Sudden Cardiac Death PrEdiction', 'orgStudyIdInfo': {'id': 'CHUBX 2022/37'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Implantation of an ICD', 'description': 'Patients implanted with an ICD', 'interventionNames': ['Device: Implantation of an ICD']}, {'type': 'NO_INTERVENTION', 'label': 'Clinical follow-up', 'description': 'Patients not implanted with an ICD'}], 'interventions': [{'name': 'Implantation of an ICD', 'type': 'DEVICE', 'description': 'Implantation of an ICD', 'armGroupLabels': ['Implantation of an ICD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Grégoire MASSOULLIE, MD', 'role': 'CONTACT', 'email': 'gmassoullie@chuclermontferrand.fr', 'phone': '+33(0)4 73 75 14 10'}, {'name': 'Grégoire MASSOULLIE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '33604', 'city': 'Pessac', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mélissa LABEQUE', 'role': 'CONTACT', 'email': 'melissa.lavevre@chu-bordeaux.fr', 'phone': '+33(0)5 57 62 31 32'}, {'name': 'Sylvain PLOUX', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Bordeaux - Hôpital Cardiologique du Haut-Lévêque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '42270', 'city': 'Saint-Etienne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Karim BENALI, MD', 'role': 'CONTACT', 'email': 'karim.benali@chu-stetienne.fr', 'phone': '+33(0)4 77 82 83 40'}, {'name': 'Karim BENALI, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'centralContacts': [{'name': 'Sylvain PLOUX, MD', 'role': 'CONTACT', 'email': 'sylvain.ploux@chu-bordeaux.fr', 'phone': '+33(0)5 57 65 64 71'}, {'name': 'Mélissa LABEQUE', 'role': 'CONTACT', 'email': 'melissa.lavevre@chu-bordeaux.fr', 'phone': '+33(0)5 57 62 31 32'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}