Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2026-02-25 @ 4:59 PM
Study NCT ID:
NCT01992458
Status:
COMPLETED
Last Update Posted:
2013-11-25
First Post:
2013-11-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary Prevention ICD French Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003643', 'term': 'Death'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D003645', 'term': 'Death, Sudden'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5576}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-19', 'studyFirstSubmitDate': '2013-11-12', 'studyFirstSubmitQcDate': '2013-11-19', 'lastUpdatePostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidences of Appropriate Therapies (ATP and Shocks) and ICD-Related Complications', 'timeFrame': '3-year'}], 'secondaryOutcomes': [{'measure': 'Cause-of-Death Analysis', 'timeFrame': '3-year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['implantable cardioverter defibrillator', 'death', 'shock', 'mortality', 'complication', 'sudden death'], 'conditions': ['Evaluation of Primary Prevention ICD in Real Life']}, 'referencesModule': {'references': [{'pmid': '28859794', 'type': 'DERIVED', 'citation': 'Escande W, Boveda S, Defaye P, Leclercq C, Sadoul N, Perier MC, Deharo JC, Fauchier L, Marijon E, Piot O; DAI-PP Investigators. Outcomes in Guideline-Based Versus Off-Guideline Primary Prevention Implantable Cardioverter-Defibrillator Recipients. J Am Coll Cardiol. 2017 Sep 5;70(10):1302-1303. doi: 10.1016/j.jacc.2017.07.711. No abstract available.'}, {'pmid': '28082419', 'type': 'DERIVED', 'citation': 'Amara N, Boveda S, Defaye P, Klug D, Treguer F, Amet D, Perier MC, Gras D, Algalarrondo V, Bouzeman A, Piot O, Deharo JC, Fauchier L, Babuty D, Bordachar P, Sadoul N, Marijon E, Leclercq C; DAI-PP Investigators. Implantable cardioverter-defibrillator therapy among patients with non-ischaemic vs. ischaemic cardiomyopathy for primary prevention of sudden cardiac death. Europace. 2018 Jan 1;20(1):65-72. doi: 10.1093/europace/euw379.'}, {'pmid': '27989789', 'type': 'DERIVED', 'citation': 'Clementy N, Challal F, Marijon E, Boveda S, Defaye P, Leclercq C, Deharo JC, Sadoul N, Klug D, Piot O, Gras D, Bordachar P, Algalarrondo V, Fauchier L, Babuty D; DAI-PP Investigators. Very high rate programming in primary prevention patients with reduced ejection fraction implanted with a defibrillator: Results from a large multicenter controlled study. Heart Rhythm. 2017 Feb;14(2):211-217. doi: 10.1016/j.hrthm.2016.10.024. Epub 2016 Oct 28.'}, {'pmid': '27609689', 'type': 'DERIVED', 'citation': 'Escande W, Marijon E, Defaye P, Piot O, Leclercq C, Sadoul N, Deharo JC, Empana JP, Boveda S, Klug D. Electrical Storms in Patients With Implantable Cardioverter-Defibrillators for Primary Prevention. J Am Coll Cardiol. 2016 Sep 13;68(11):1248-1250. doi: 10.1016/j.jacc.2016.06.039. No abstract available.'}, {'pmid': '26873687', 'type': 'DERIVED', 'citation': 'Providencia R, Marijon E, Lambiase PD, Bouzeman A, Defaye P, Klug D, Amet D, Perier MC, Gras D, Algalarrondo V, Deharo JC, Leclercq C, Fauchier L, Babuty D, Bordachar P, Sadoul N, Piot O, Boveda S. Primary Prevention Implantable Cardioverter Defibrillator (ICD) Therapy in Women-Data From a Multicenter French Registry. J Am Heart Assoc. 2016 Feb 12;5(2):e002756. doi: 10.1161/JAHA.115.002756.'}]}, 'descriptionModule': {'briefSummary': 'The indication of implantable cardioverter defibrillator (ICD) therapy for primary prevention of sudden cardiac death has been introduced later in France than in other parts of the World. Overall, we aimed to assess the risk-benefit ratio of this strategy over a 10 year period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients from 12 medical centers implanted with an implantable cardioverter defibrillator (ICD) in the setting of primary prevention since Jan. 1, 1997, in France', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Coronary artery disease or dilated cardiomyopathy with low ejection fraction implanted with an ICD in the setting of primary prevention (criteria at the discretion of the physician)\n\nExclusion Criteria:\n\n* Setting of secondary prevention\n* Other cardiopathies such as congenital, channelopathies, valvulopathies'}, 'identificationModule': {'nctId': 'NCT01992458', 'acronym': 'DAI-PP', 'briefTitle': 'Primary Prevention ICD French Registry', 'organization': {'class': 'OTHER', 'fullName': 'Clinique Pasteur'}, 'officialTitle': 'Observatoire Multicentrique Français Des Porteurs de Défibrillateur Automatique Implantable en Prévention Primaire (Cardiopathie Ischémique ou Cardiomyopathie Dilatée)', 'orgStudyIdInfo': {'id': '913203'}}, 'contactsLocationsModule': {'locations': [{'city': 'Toulouse', 'country': 'France', 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Serge Boveda, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique Pasteur'}, {'name': 'Eloi Marijon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital européen Georges Pompidou'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinique Pasteur', 'class': 'OTHER'}, 'collaborators': [{'name': 'Clinique Pasteur Toulouse', 'class': 'OTHER'}, {'name': 'European Georges Pompidou Hospital', 'class': 'OTHER'}, {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, {'name': 'University Hospital, Lille', 'class': 'OTHER'}, {'name': 'University Hospital, Marseille', 'class': 'OTHER'}, {'name': 'Centre Cardiologique du Nord, St Denis', 'class': 'UNKNOWN'}, {'name': 'Nouvelles Cliniques Nantaises, Nantes', 'class': 'UNKNOWN'}, {'name': 'Hopital Antoine Beclere, Clamart', 'class': 'UNKNOWN'}, {'name': 'Rennes University Hospital', 'class': 'OTHER'}, {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, {'name': 'University Hospital, Tours', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Serge Boveda', 'investigatorAffiliation': 'Clinique Pasteur'}}}}