Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-01 @ 7:04 AM
Study NCT ID:
NCT00286858
Status:
COMPLETED
Last Update Posted:
2021-01-28
First Post:
2006-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Beluga - Clinical Observations of Automatic Algorithms for Cardiac Pacing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001919', 'term': 'Bradycardia'}, {'id': 'D012804', 'term': 'Sick Sinus Syndrome'}, {'id': 'D006327', 'term': 'Heart Block'}], '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'}, {'id': 'D001146', 'term': 'Arrhythmia, Sinus'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 903}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-27', 'studyFirstSubmitDate': '2006-02-02', 'studyFirstSubmitQcDate': '2006-02-02', 'lastUpdatePostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of Atrio-ventricular hysteresis algorithm on percentage of Ventricular pacing', 'timeFrame': 'At 12 Months', 'description': '% Vp is compared between patients with atrio-ventricular hysteresis algorithm ON and OFF in patients with sino-atrial disease or paroxysmal AV block.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bradycardia', 'Sick Sinus Syndrome', 'Heart Block']}, 'descriptionModule': {'briefSummary': 'This study shall evaluate in daily medical practice the clinical results of the AV delay hysteresis search algorithm in patients with a INSIGNIA ULTRA or AVT pacemaker implanted for one of the three following indications: sinus node dysfunction, atrial disease (or bradycardia/tachycardia) and atrio-ventricular paroxysmal block. In addition use and outcome of automatic functions will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients with indication for a dual chamber pacemaker and not having a complete AV-block are invited to participate.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dual chamber pacemaker (INSIGNIA ULTRA or AVT pacemaker), implant not older than 60 days, estimated life expectancy more than one year in case of associated illness, Age ≥ 18 years, signed patient information.\n\nExclusion Criteria:\n\n* Indication for conventional treatment with ventricular resynchronisation or by implantable defibrillator during inclusion, implanted for severe permanent AVB (AVB 2/1 and complete), PR \\> 250 ms, implant of the device older than 60 days before the inclusion date, Heart transplant foreseen within six months, unexplained syncope.'}, 'identificationModule': {'nctId': 'NCT00286858', 'briefTitle': 'Beluga - Clinical Observations of Automatic Algorithms for Cardiac Pacing', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Clinical Observations of Automatic Algorithms for Cardiac Pacing', 'orgStudyIdInfo': {'id': 'Beluga'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Insignia Ultra and Insignia AVT', 'type': 'DEVICE', 'description': 'Regular AV-Delay increase to allow for intrinsic AV conduction, if present.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'CHRU- Hôpital Nord', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '64320', 'city': 'Aressy', 'country': 'France', 'facility': 'Clinique Cardiologique Aressy', 'geoPoint': {'lat': 43.2765, 'lon': -0.32425}}, {'zip': '74370', 'city': 'Argonay', 'country': 'France', 'facility': "Clinique du Lac et d'Argonay", 'geoPoint': {'lat': 45.94482, 'lon': 6.14436}}, {'zip': '13200', 'city': 'Arles', 'country': 'France', 'facility': "CH d'Arles", 'geoPoint': {'lat': 43.67681, 'lon': 4.63031}}, {'zip': '64100', 'city': 'Bayonne', 'country': 'France', 'facility': 'Clinique Paulmy', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'zip': '60021', 'city': 'Beauvais', 'country': 'France', 'facility': 'CH Beauvais', 'geoPoint': {'lat': 49.43333, 'lon': 2.08333}}, {'zip': '33200', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Polyclinique Bordeaux-Cauderan', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '19316', 'city': 'Brive-la-Gaillarde', 'country': 'France', 'facility': 'Clinique des Cèdres', 'geoPoint': {'lat': 45.1589, 'lon': 1.53326}}, {'zip': '14050', 'city': 'Caen', 'country': 'France', 'facility': 'CH privé St. Martin', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '81100', 'city': 'Castres', 'country': 'France', 'facility': 'CHI de Castres', 'geoPoint': {'lat': 43.60527, 'lon': 2.24088}}, {'zip': '35510', 'city': 'Cesson-Sévigné', 'country': 'France', 'facility': 'Polyclinique Sévigné', 'geoPoint': {'lat': 48.1212, 'lon': -1.603}}, {'zip': '28000', 'city': 'Chartres', 'country': 'France', 'facility': 'Hôpital Fontenoy', 'geoPoint': {'lat': 48.44685, 'lon': 1.48925}}, {'zip': '50000', 'city': 'Cherbourg', 'country': 'France', 'facility': 'CH Cherbourg', 'geoPoint': {'lat': 49.63984, 'lon': -1.61636}}, {'zip': '40100', 'city': 'Dax', 'country': 'France', 'facility': 'CH DAX', 'geoPoint': {'lat': 43.71032, 'lon': -1.05366}}, {'zip': '22100', 'city': 'Dinan', 'country': 'France', 'facility': 'CHG de Dinan', 'geoPoint': {'lat': 48.45553, 'lon': -2.05049}}, {'zip': '83300', 'city': 'Draguignan', 'country': 'France', 'facility': 'Clinique Notre Dame', 'geoPoint': {'lat': 43.53692, 'lon': 6.46458}}, {'zip': '54271', 'city': 'Essey-lès-Nancy', 'country': 'France', 'facility': 'Polyclinique Louis Pasteur', 'geoPoint': {'lat': 48.705, 'lon': 6.22691}}, {'zip': '27023', 'city': 'Évreux', 'country': 'France', 'facility': 'CHG Saint Louis - SIH Eure Seine', 'geoPoint': {'lat': 49.02414, 'lon': 1.15082}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU Albert Michalon', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '13600', 'city': 'La Ciotat', 'country': 'France', 'facility': 'Casamance', 'geoPoint': {'lat': 43.17476, 'lon': 5.60449}}, {'zip': '85025', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'CH de La Roche sur Yon', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '53024', 'city': 'Laval', 'country': 'France', 'facility': 'CH de Laval', 'geoPoint': {'lat': 48.07247, 'lon': -0.77019}}, {'zip': '59003', 'city': 'Lille', 'country': 'France', 'facility': 'Polyclinique du Bois', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '13915', 'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '68070', 'city': 'Mulhouse', 'country': 'France', 'facility': 'CH Emile Muller', 'geoPoint': {'lat': 47.75205, 'lon': 7.32866}}, {'zip': '44110', 'city': 'Nantes', 'country': 'France', 'facility': 'Nouvelles Cliniques Nantaises', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '92200', 'city': 'Neuilly-sur-Seine', 'country': 'France', 'facility': 'Clinique Ambroise Paré', 'geoPoint': {'lat': 48.8846, 'lon': 2.26965}}, {'zip': '58033', 'city': 'Nevers', 'country': 'France', 'facility': 'CH Nevers', 'geoPoint': {'lat': 46.98956, 'lon': 3.159}}, {'zip': '30006', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '94130', 'city': 'Nogent-sur-Marne', 'country': 'France', 'facility': 'Clinique A. Brillard', 'geoPoint': {'lat': 48.83669, 'lon': 2.48255}}, {'zip': '45067', 'city': 'Orléans', 'country': 'France', 'facility': 'CHR la Source', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '64046', 'city': 'Pau', 'country': 'France', 'facility': 'CHG de Pau', 'geoPoint': {'lat': 43.31117, 'lon': -0.35583}}, {'zip': '66046', 'city': 'Perpignan', 'country': 'France', 'facility': 'CH Maréchal Joffre', 'geoPoint': {'lat': 42.69764, 'lon': 2.89541}}, {'zip': '76000', 'city': 'Rouen', 'country': 'France', 'facility': 'Clinique St Hilaire', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '42000', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHP de la Loire', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '38400', 'city': "Saint-Martin-d'Hères", 'country': 'France', 'facility': 'Clinique Belledone', 'geoPoint': {'lat': 45.1787, 'lon': 5.76281}}, {'zip': '65000', 'city': 'Tarbes', 'country': 'France', 'facility': "Clinique de L'Ormeau", 'geoPoint': {'lat': 43.23407, 'lon': 0.07139}}, {'zip': '31076', 'city': 'Toulouse', 'country': 'France', 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Hôpital de Brabois', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'zip': '97159', 'city': 'Pointe-à-Pitre', 'country': 'Guadeloupe', 'facility': 'CHU de Point à pitre', 'geoPoint': {'lat': 16.23638, 'lon': -61.53459}}], 'overallOfficials': [{'name': 'Olivier THOMAS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique Ambroise Paré'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}