Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-28 @ 5:50 AM
Study NCT ID:
NCT04757168
Status:
RECRUITING
Last Update Posted:
2024-10-23
First Post:
2021-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in Regional and Global Cardiac Contractility After Stimulation in Scar Zone with the NOGA System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-21', 'studyFirstSubmitDate': '2021-02-04', 'studyFirstSubmitQcDate': '2021-02-16', 'lastUpdatePostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evolution of LLS (linear local shortening) via the NOGATM system in percentage', 'timeFrame': '1month', 'description': 'Study the change in percentage of LLS during stimulation in a post-infarction scar zone identified by voltage mapping of the left ventricle with the NOGA system, compared to LLS in the same zone measured in atrial stimulation'}], 'secondaryOutcomes': [{'measure': 'Evolution of global systolic function: left ventricular ejection fraction', 'timeFrame': '1month', 'description': 'Compare the left ventricular ejection fraction (in percentage) during stimulation in a scar area compared to a normal rhythm'}, {'measure': 'Evolution of the global systolic function: integral time velocity under aortic Translation results Evolution of the global systolic function: integral time velocity under aortic', 'timeFrame': '1month', 'description': 'Compare the integral time velocity under aortic (in centimeter) during stimulation in a scar area compared to a normal rhythm'}, {'measure': 'Evolution of the global systolic function: strain longitudinal global', 'timeFrame': '1month', 'description': 'Compare the strain longitudinal global(in percentage) during stimulation in a scar area compared to a normal rhythm'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stimulation in cardiac scar area'], 'conditions': ['Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'Despite a decrease in voltage amplitude in post-infarction scar areas, greater voltage amplitudes are sometimes observed at the time of local extrasystoles mechanically induced by catheters.\n\nHowever, no study has investigated whether these electrical changes are associated with mechanical changes in local contractility.\n\nHowever, the voltage is closely correlated to the local contractile function as evidenced by the use of the NOGA system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients who should undergo ventricular tachycardia (VT) ablation after a myocardial infarction according to current recommendations, namely: patients with ischemic heart disease (ICD) and with episodes of sustained ventricular tachycardia responsible for internal electric shocks by the implantable automatic defibrillator (ICD) (grade IB recommendation)\n\nOR\n\n* patients with an MIC and an ICD, presenting a first episode of sustained ventricular tachycardia (grade IIa, B recommendation)\n* Affiliated with a social protection scheme\n* Having signed an informed consent\n\nExclusion Criteria:\n\n* Contraindication or non-indication for ventricular tachycardia ablation\n* Women who are pregnant or of childbearing age and without contraception, breastfeeding women\n* Patients without ischemic heart disease\n* Patients under guardianship, curatorship or legal protection.'}, 'identificationModule': {'nctId': 'NCT04757168', 'acronym': 'SCARPACE', 'briefTitle': 'Changes in Regional and Global Cardiac Contractility After Stimulation in Scar Zone with the NOGA System', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Changes in Regional and Global Cardiac Contractility After Stimulation in Scar Zone with the NOGA System', 'orgStudyIdInfo': {'id': 'RC31/19/0513'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NOGA TM probe', 'interventionNames': ['Device: NOGA TM probe']}], 'interventions': [{'name': 'NOGA TM probe', 'type': 'DEVICE', 'description': 'Each subject will be his own witness since the linear local shortening (LLS) will be measured successively in all patients before, then after stimulation of the scar zone (comparison of LLS measured in sinus rhythm then during stimulation in the scar zone for each patient.\n\nEach subject being his own witness and the two recordings being made a few minutes apart, during the same procedure.', 'armGroupLabels': ['NOGA TM probe']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'state': 'CHU de Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne ROLLIN', 'role': 'CONTACT', 'email': 'rollin.a@chu-toulouse.fr'}], 'facility': 'ROLLIN Anne', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Anne ROLLIN, MD', 'role': 'CONTACT', 'email': 'rollin.a@chu-toulouse.fr', 'phone': '5 61 32 24 29', 'phoneExt': '+33'}, {'name': 'Philippe MAURY, MD', 'role': 'CONTACT', 'email': 'maury.p@chu-toulouse.fr', 'phone': '5 61 34 10 18', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Anne ROLLIN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}