Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-26 @ 4:31 AM
Study NCT ID:
NCT01015859
Status:
COMPLETED
Last Update Posted:
2013-10-30
First Post:
2009-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spontaneous Atrioventricular Conduction Preservation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 370}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-29', 'studyFirstSubmitDate': '2009-11-16', 'studyFirstSubmitQcDate': '2009-11-17', 'lastUpdatePostDateStruct': {'date': '2013-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to evaluate the effectiveness of SafeR', 'timeFrame': '1 and 3 years'}, {'measure': 'preserve natural AV conduction compared to DDD Long AVD', 'timeFrame': '1 and 3 years'}, {'measure': 'demonstrate the effectiveness of SafeR to reduce AF incidence on a LT basis', 'timeFrame': '1 and 3 years'}, {'measure': 'compare the effects of SafeR vs DDD Long AVD on LV function', 'timeFrame': '1 and 3 years'}], 'secondaryOutcomes': [{'measure': 'total mortality', 'timeFrame': '1 and 3 years'}, {'measure': 'CHF-related mortality & hospitalisations', 'timeFrame': '1 and 3 years'}, {'measure': 'evolution of systemic BP', 'timeFrame': '1 and 3 years'}, {'measure': 'AF-related AEs', 'timeFrame': '1 and 3 years'}, {'measure': 'evolution of cardiac asynchrony [interventricular (RV-LV) & intraventricular (4 segments)', 'timeFrame': '1 and 3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['AV conduction', 'Atrial fibrillation'], 'conditions': ['Patients With Pacemaker With Conduction Problems']}, 'descriptionModule': {'briefSummary': 'The aims of this study are to assess the clinical benefits resulting from SafeR by comparison with standard dual chamber programming (DDD) with a long atrioventricular (AV) delay.\n\nThe benefits will be assessed by comparing the percentage of ventricular pacing, the incidence of atrial arrhythmias, and the evolution of the hemodynamic status as observed through echo parameter and atrial natriuretic peptide/brain natriuretic peptide (ANP/BNP) measurements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient who fulfils one or more of the official guidelines to be implanted with a dual-chamber pacemaker (primo-implantation3) may be included in the study.\n\nExclusion Criteria:\n\nThe patients presenting with one or more of the following characteristics cannot be included:\n\nPermanent complete AV block\n\n* Permanent atrial and/or ventricular arrhythmias\n* already implanted with a cardioverter-defibrillator (ICD)\n* Likely to have a cardiac surgery in the next six months, mainly for:\n* severe coronary artery disease\n* severe valvular disease\n* AV node ablation\n* Refuses to sign an consent form after having received the appropriate information\n* Refuses to co-operate\n* Not able to understand the study objectives and protocol\n* Not available for scheduled follow-up\n* With a life expectancy less than one year\n* Already included into another clinical study competing with the objectives of the CAN-SAVE R study\n* \\<18 years old'}, 'identificationModule': {'nctId': 'NCT01015859', 'acronym': 'CAN-SAVER', 'briefTitle': 'Spontaneous Atrioventricular Conduction Preservation', 'organization': {'class': 'OTHER', 'fullName': 'Montreal Heart Institute'}, 'officialTitle': 'A Prospective Canadian Multi-center Randomized Study of the Benefits of Spontaneous Atrioventricular Conduction (Can Save R)', 'orgStudyIdInfo': {'id': 'Protocol IGxD04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'DDD long AV delay', 'description': 'Pacemaker is programmed in DDD mode with long AV delay (250 msec)'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AAI SafeR', 'description': 'Pacemaker is programmed in AAI SafeR mode', 'interventionNames': ['Device: Pacing mode']}], 'interventions': [{'name': 'Pacing mode', 'type': 'DEVICE', 'description': 'To determine which mode (DDD vs AAI SafeR)minimizes ventricular pacing', 'armGroupLabels': ['AAI SafeR']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T5H 3V9', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Royal Alexandra Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'T6L 5X8', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Grey Nuns Hospital, Edmonton', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'K7L 2V7', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Kingston Hospital, Queens University', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'L3Y 2P9', 'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Southlake Regional Hospital', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'G1V 4G5', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institut Universitaire de Cardiologie et de Pneumologie', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'J7Z 5T3', 'city': 'Saint Jérome', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hôtel-Dieu de St Jérome'}, {'zip': 'G8Z 3R9', 'city': 'Trois-Rivières', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre hospitalier régional de Trois-Rivières', 'geoPoint': {'lat': 46.34515, 'lon': -72.5477}}, {'zip': 'S7N 0W8', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Royal University Hospital, Saskatoon', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Bernard Thibault, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montreal Heart Institute, Research Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montreal Heart Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sorin Group Canada', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiologist', 'investigatorFullName': 'Bernard Thibault', 'investigatorAffiliation': 'Montreal Heart Institute'}}}}