Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-02-21 @ 9:25 PM
Study NCT ID:
NCT02433756
Status:
UNKNOWN
Last Update Posted:
2016-03-31
First Post:
2015-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RESponders and QUadripolar LV Lead in CRT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}, 'targetDuration': '18 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-29', 'studyFirstSubmitDate': '2015-04-22', 'studyFirstSubmitQcDate': '2015-04-29', 'lastUpdatePostDateStruct': {'date': '2016-03-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients presenting improving in Heart Failure Clinical Composite and reverse remodeling after 6 months', 'timeFrame': '6-Months'}, {'measure': 'Percentage of patients presenting improving in Heart Failure Clinical Composite and reverse remodeling after 12 months', 'timeFrame': '12-Months'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients presenting improving in Heart Failure Clinical Composite and reverse remodeling after 18 months', 'timeFrame': '18 months'}]}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to observe the evolution of the CRTD system with left quadripolar lead, in terms of electrical parameters in all pacing configurations and to evaluate the impact on the clinical outcome.', 'detailedDescription': 'Cardiac resynchronization therapy (CRT) is limited by a high proportion of non-responders.\n\nPacing activation from proximal area with a left quadripolar lead might improve the depolarization pattern.\n\nTo explore the effect of CRT pacing on cardiac activity, the investigators will enroll approximately 180 patients who already underwent CRT-D implantation with a quadripolar LV lead.\n\nAfter implant, as clinical practice, the device will be programmed with distal LV pacing configuration, after 6 months in patient non-responders to CRT therapy the pacing configuration will be changed (proximal configuration).\n\nAfter 12 months in patients non-responders will be changed the pacing configuration again, choosing, if it is possible, a multi point pacing (pacing activation from multiple separated left ventricular (LV) sites).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Heart Failure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be in NYHA II, III or IV functional class with approved standard indication by ESC/EHRA Guidelines\n* Successful quadripolar LV lead implant\n\nExclusion Criteria:\n\n* Less than 18 years of age\n* Epicardial Lead\n* Life expectancy \\< 12 months\n* Pregnant or are planning to become pregnant during the duration of the investigation'}, 'identificationModule': {'nctId': 'NCT02433756', 'acronym': 'ResQ CRT', 'briefTitle': 'RESponders and QUadripolar LV Lead in CRT', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale Santa Croce-Carle Cuneo'}, 'officialTitle': 'Responders and Quadripolar LV Lead in CRT', 'orgStudyIdInfo': {'id': '001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CRTD', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cirié', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gaetano Senatore', 'role': 'CONTACT', 'email': 'resqcrt@gmail.com'}], 'facility': 'Ciriè Hospital', 'geoPoint': {'lat': 45.23486, 'lon': 7.60125}}, {'city': 'Cuneo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonello Vado', 'role': 'CONTACT', 'email': 'resqcrt@gmail.com'}], 'facility': 'S.Croce e Carle Hospital', 'geoPoint': {'lat': 44.39071, 'lon': 7.54828}}, {'city': 'Torino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Massimo Giammaria', 'role': 'CONTACT', 'email': 'resqcrt@gmail.com'}], 'facility': 'Maria Vittoria Hospital', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale Santa Croce-Carle Cuneo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Antonello Vado', 'investigatorAffiliation': 'Ospedale Santa Croce-Carle Cuneo'}}}}