Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-01-04 @ 11:05 PM
Study NCT ID:
NCT03099057
Status:
TERMINATED
Last Update Posted:
2025-02-06
First Post:
2017-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Prognostic Factors in Interventional Rhythmology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2805}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Lake of personnel', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2017-03-17', 'studyFirstSubmitQcDate': '2017-03-28', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The occurrence of adverse clinical events', 'timeFrame': '5 years', 'description': 'The occurrence of the following adverse clinical events: infectious, rhythmic complications, hemodynamic, mortality any causes and cardiovascular post--interventional and in the length-course'}], 'secondaryOutcomes': [{'measure': 'duration of intervention', 'timeFrame': 'Day 1', 'description': 'The duration of the operation of interventional rhythmology will be measured'}, {'measure': 'dose of X-radiation used', 'timeFrame': 'Day1', 'description': 'the dose of X-radiation used shall be measured'}, {'measure': 'volume of used contrast agent', 'timeFrame': 'Day1', 'description': 'The volume of used contrast agent will be measured'}, {'measure': 'duration of hospitalization', 'timeFrame': '3 months', 'description': 'the duration of hospitalization will be measured'}, {'measure': 'need for reoperation', 'timeFrame': '5 years', 'description': 'the need for reoperation will be assessed'}, {'measure': 'evolution of the ECG', 'timeFrame': '5 years', 'description': 'The evolution of the ECG will be estimated'}, {'measure': 'evolution of the echocardiographic parameters', 'timeFrame': '5 years', 'description': 'the evolution of the echocardiographic parameters will be estimated'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'Develop a prospective register assessing the short- and long-term complications of patients undergoing interventional rhythm', 'detailedDescription': 'To assess the fate of patients who have undergone a technical procedure at the Cardiology Plate (implantation / extraction of a pacemaker, a defibrillator, radiofrequency ablation or cryo-ablation, left auricle closure, electro- Physiological exploration), and to determine prognostic factors / markers in this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient that must undergo a gesture of interventional rythmology in the Department of Cardiology of the CHRU of Brest', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatient to undergo:\n\n* Implantation of a cardiac pacemaker or cardiac defibrillator or\n* Extraction of pacemaker / defibrillator housing or probes or\n* Realization of a radiofrequency / cryo-ablation:\n* Atrial fibrillation\n* Focus of ventricular tachycardia\n* An accessory or\n* Any electrophysiological exploration or\n* Installation of Holter implantable or\n* Left auricular closure percutaneously Having formulated its non-opposition\n\nExclusion Criteria:\n\n* Minor\n* Patient's refusal\n* Patients under legal protection"}, 'identificationModule': {'nctId': 'NCT03099057', 'acronym': 'PRINT', 'briefTitle': 'Study of Prognostic Factors in Interventional Rhythmology', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Study of Prognostic Factors in Interventional Rhythmology', 'orgStudyIdInfo': {'id': '29BRC16.0104'}}, 'armsInterventionsModule': {'interventions': [{'name': 'follow-up of patients after interventional rhythm operation', 'type': 'OTHER', 'description': 'The follow-up will take place at 3 months postoperatively, then at 1 year and then annually for 5 years.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '29200', 'city': 'Brest', 'country': 'France', 'facility': 'CHRU Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}], 'overallOfficials': [{'name': 'Jacques Mansourati, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Brest'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}