Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-29 @ 12:43 PM
Study NCT ID:
NCT02571868
Status:
COMPLETED
Last Update Posted:
2015-10-08
First Post:
2015-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute and Cronic Evaluation of AV/PV and VV Delay IEGM Based Optimisation Algorithm-QuickSept Study
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-07', 'studyFirstSubmitDate': '2015-10-05', 'studyFirstSubmitQcDate': '2015-10-07', 'lastUpdatePostDateStruct': {'date': '2015-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between QuickOptTM and standard ECHO optimization', 'timeFrame': '12-month', 'description': 'The primary endpoint was assessed by means the linear correlation analysis by the Pearson product-moment correlation coefficient to assess the agreement between the ECHO-based and the IEGM-based aVTIs for each of the AV/PV, and VV delay determinations'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'AtrioVentricular (AV) and InterVentricular (VV) delay optimization can improve ventricular function in Cardiac Resynchronization Therapy (CRT) and is usually performed by means of echocardiography. St Jude Medical has developed an automated algorhythm which calculates the optimal AV and VV delays (QuickOptTM) based on Intracardiac ElectroGrams, (IEGM), within 2 minutes. So far, the efficacy of the algorhythm has been tested acutely with standard lead position at right ventricular (RV) apex. Aim of this project is to evaluate the algorhythm performance in the mid- and long-term with RV lead located in mid-septum.', 'detailedDescription': 'Primary end-point was to evaluate the relationship between the series of aortic flow Velocity Time Integral (aVTI) values calculated by the two methods at the PV, AV, and VV interval settings recommended by both the QuickOptTM and the standard ECHO optimization in CRT-D patients, at three index times: pre-discharge, at 6-month and at 12-month follow-ups.\n\nSecondary end-point was to define the correlation between the optimal AV, PV and VV intervals defined by ECHO, using aVTI measurements and by the QuickOptTM algorithm, IEGM-based.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with CRT-D', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with CRT-D\n* stable and safe placement of an active-fixation RV lead on mid-interventricular septum;\n* achievement of an efficacious LV intravenous pacing from a Coronary Sinus (CS) branch.\n\nExclusion Criteria:\n\n* AF\n* Patients without spontaneous rhythm'}, 'identificationModule': {'nctId': 'NCT02571868', 'acronym': 'QuickSept', 'briefTitle': 'Acute and Cronic Evaluation of AV/PV and VV Delay IEGM Based Optimisation Algorithm-QuickSept Study', 'organization': {'class': 'OTHER', 'fullName': 'Maria Vittoria Hospital'}, 'officialTitle': 'Acute and Cronic Evaluation of AV/PV and VV Delay IEGM Based Optimisation Algorithm (QuickOpt™) Compared With Echocardiographic Method for Cardiac Resincronization Therapy in CRT Implants With Right Interventricular Basal-Mid Septum Placement of Leads (QuickSept Study)', 'orgStudyIdInfo': {'id': '002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Optimization CRT-D', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Torino', 'state': 'Italy', 'country': 'Italy', 'facility': 'Ospedale Maria Vittoria', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maria Vittoria Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Dr.Massimo Giammaria', 'investigatorAffiliation': 'Maria Vittoria Hospital'}}}}