Ignite Creation Date:
2025-12-24 @ 12:11 PM
Ignite Modification Date:
2026-01-09 @ 2:39 AM
Study NCT ID:
NCT00323661
Status:
COMPLETED
Last Update Posted:
2012-02-13
First Post:
2006-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Closed Loop Stimulation, Cognitive Performance, and Quality of Life in Pacemaker Patients
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': 405}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-10', 'studyFirstSubmitDate': '2006-05-08', 'studyFirstSubmitQcDate': '2006-05-08', 'lastUpdatePostDateStruct': {'date': '2012-02-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive performance assessed by the Number Connection Test', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Quality of life assessed by the SF-08', 'timeFrame': '12 months and 24 months'}, {'measure': 'occurrence of atrial fibrillation', 'timeFrame': '12 months and 24 months'}, {'measure': 'occurrence of serious adverse events', 'timeFrame': '12 months and 24 months'}, {'measure': 'self-assessment of general well-being, mental and physical performance assessed by Visual Analogue Scales', 'timeFrame': '12 months and 24 months'}, {'measure': 'Home Monitoring data', 'timeFrame': '24 months'}]}, 'conditionsModule': {'keywords': ['Pacing', 'Rate-adaptive', 'Quality of life', 'Cognitive performance', 'Atrial fibrillation', 'Pacemaker sensor'], 'conditions': ['Cardiac Pacing, Artificial']}, 'referencesModule': {'references': [{'pmid': '18507543', 'type': 'BACKGROUND', 'citation': 'Wiegand U, Nuernberg M, Maier SK, Weiss C, Sancho-Tello MJ, Hartmann A, Schuchert A, Maier P, Chan NY. The COGNITION study rationale and design: influence of closed loop stimulation on cognitive performance in pacemaker patients. Pacing Clin Electrophysiol. 2008 Jun;31(6):709-13. doi: 10.1111/j.1540-8159.2008.01075.x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the influence of accelerometer-based rate adaptation and Closed Loop Stimulation on cognitive performance and quality of life in pacemaker patients.', 'detailedDescription': 'Within the scope of a usual follow-up schedule the influence of the mode of rate-adaptation on cognitive performance of pacemaker patients will be analysed. Accelerometer sensor will be compared with Closed Loop Stimulation over 2 years. The cognitive performance will be measured by means of a standardized psychometric test. The occurrence of atrial fibrillation and serious adverse events, patient self-assessment and quality of life will be evaluated. An analysis of the telemonitored (Home Monitoring) data will be performed in order to identify predictors of changes or differences in cognitive performance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with a CYLOS pacemaker (implantation within the last 3 to 6 weeks)\n* Closed Loop Stimulation mode activated since pre-hospital discharge\n* Patients with chronotropic incompetence according to physician's judgment\n* Maximum sinus rate \\< 100 beats per minute (bpm) OR percentage of atrial pacing ≥ 25%\n* Patients suitable for rate-adaptive pacing for at least 2 years\n* Patient informed consent\n\nExclusion Criteria:\n\n* Age under 55\n* Pregnant and breast-feeding women\n* Patients who are already enrolled in another study"}, 'identificationModule': {'nctId': 'NCT00323661', 'acronym': 'COGNITION', 'briefTitle': 'Closed Loop Stimulation, Cognitive Performance, and Quality of Life in Pacemaker Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotronik SE & Co. KG'}, 'officialTitle': 'COGNITION - Cognitive Performance & Closed Loop Stimulation', 'orgStudyIdInfo': {'id': 'BA079'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Rate-adaptation by Closed Loop Stimulation', 'interventionNames': ['Device: Rate-adaptive pacemaker: Closed Loop Stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Accelerometer based pacing rate adaptation', 'interventionNames': ['Device: Rate-adaptive pacemaker: accelerometer']}], 'interventions': [{'name': 'Rate-adaptive pacemaker: accelerometer', 'type': 'DEVICE', 'description': 'Accelerometer based pacing rate adaptation', 'armGroupLabels': ['2']}, {'name': 'Rate-adaptive pacemaker: Closed Loop Stimulation', 'type': 'DEVICE', 'description': 'Closed Loop Stimulation (CLS) is a unique concept in rate-adaptive pacing that uses the natural cardiovascular control loop to determine the appropriate pacing rate. Closed Loop Stimulation is the only rate-adaptive system responding to mental stress and thereby assuring optimal cerebral perfusion in everyday activity.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NSW 2076', 'city': 'Sydney', 'country': 'Australia', 'facility': 'Sydney Adventist Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '4020', 'city': 'Linz', 'country': 'Austria', 'facility': 'A.ö. Krankenhaus der Stadt Linz', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '4910', 'city': 'Ried', 'country': 'Austria', 'facility': 'Krankenhaus der Barmherzigen Schwestern Ried', 'geoPoint': {'lat': 47.99722, 'lon': 12.96639}}, {'zip': '4400', 'city': 'Steyr', 'country': 'Austria', 'facility': 'A. ö. Landeskrankenhaus Steyr', 'geoPoint': {'lat': 48.04274, 'lon': 14.42127}}, {'zip': '1160', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Wilhelminenspital der Stadt Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '71525-255', 'city': 'Brasilia - DF', 'country': 'Brazil', 'facility': 'Hospital Anchieta, Instituto do Coracao de Taguatinga'}, {'zip': '90510-000', 'city': 'Porto Alegre', 'country': 'Brazil', 'facility': 'Hospital Sao Francisco', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '01323-001', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Real e Benemerita Sociedade Portuguesa de Beneficencia', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': 'V5H 2E3', 'city': 'Burnaby, B.C.', 'country': 'Canada', 'facility': 'Practice Dr. Bloomberg', 'geoPoint': {'lat': 49.26636, 'lon': -122.95263}}, {'zip': 'V1Y 1E4', 'city': 'Kelowna BC', 'country': 'Canada', 'facility': 'Kelowna Cardiology Research'}, {'zip': 'H4J 1C5', 'city': 'Montreal', 'country': 'Canada', 'facility': 'Hopital Sacre-Coeur', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'V3V 1N1', 'city': 'Surrey BC', 'country': 'Canada', 'facility': 'Dr. Dante Manyauri'}, {'zip': 'M1P 2T7', 'city': 'Toronto, Ontario', 'country': 'Canada', 'facility': 'Scarborough Cardiology Research', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '65691', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Fakultni Nemocnice u Svety Anny', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'Universitätsklinik der RWTH Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '33604', 'city': 'Bielefeld', 'country': 'Germany', 'facility': 'Städtische Kliniken Bielefeld, Klinikum Mitte', 'geoPoint': {'lat': 52.03333, 'lon': 8.53333}}, {'zip': '46397', 'city': 'Bocholt', 'country': 'Germany', 'facility': 'St. Agnes Hospital GmbH, 1. Medizinische Klinik-Kardiologie', 'geoPoint': {'lat': 51.83879, 'lon': 6.61531}}, {'zip': '96450', 'city': 'Coburg', 'country': 'Germany', 'facility': 'Klinikum Coburg', 'geoPoint': {'lat': 50.25937, 'lon': 10.96384}}, {'zip': '32756', 'city': 'Detmold', 'country': 'Germany', 'facility': 'Klinikum Lippe-Detmold', 'geoPoint': {'lat': 51.93855, 'lon': 8.87318}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Med. Klinik/Kardiologie, Herzzentrum, Universitätsklinik an der Technischen Universität Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '85560', 'city': 'Ebersberg', 'country': 'Germany', 'facility': 'Kreisklinik Ebersberg GmbH', 'geoPoint': {'lat': 48.0771, 'lon': 11.97063}}, {'zip': '50374', 'city': 'Erftstadt-Frauenthal', 'country': 'Germany', 'facility': 'Marien-Hospital Erftstadt-Frauenthal'}, {'zip': '08349', 'city': 'Erlabrunn', 'country': 'Germany', 'facility': 'Klinken Erlabrunn GmbH', 'geoPoint': {'lat': 49.85972, 'lon': 9.84417}}, {'zip': '45122', 'city': 'Essen', 'country': 'Germany', 'facility': 'Westdeutsches Herzzentrum Essen; Klinik für Kardiologie und Thorax-Kardiovaskuläre Chirurgie des Universitätsklinikums Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '60316', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Kardiologisches Zentrum am Zoo', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '33276', 'city': 'Gütersloh', 'country': 'Germany', 'facility': 'St. Elisabeth-Hospital', 'geoPoint': {'lat': 51.90693, 'lon': 8.37853}}, {'zip': '06120', 'city': 'Halle', 'country': 'Germany', 'facility': 'Klinikum der Medizinischen Fakultät Halle-Wittenberg', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '22041', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Zentrum für Kardiologische und Angiologische Medizin Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '22763', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'AK Altona', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '63450', 'city': 'Hanau', 'country': 'Germany', 'facility': 'St. Vinzenz-Krankenhaus Hanau gGmbH', 'geoPoint': {'lat': 50.13423, 'lon': 8.91418}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Universitätsklinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '32049', 'city': 'Herford', 'country': 'Germany', 'facility': 'Klinikum Herford', 'geoPoint': {'lat': 52.11457, 'lon': 8.67343}}, {'zip': '37603', 'city': 'Holzminden', 'country': 'Germany', 'facility': 'Evangelisches Krankenhaus Holzminden', 'geoPoint': {'lat': 51.82798, 'lon': 9.4455}}, {'zip': '07743', 'city': 'Jena', 'country': 'Germany', 'facility': 'Klinikum der Universität Jena Klinik für Innere Medizin I', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '24116', 'city': 'Kiel', 'country': 'Germany', 'facility': 'Kardiologische Gemeinschaftspraxis', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '04129', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Städtisches Klinikum St. Georg', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '23538', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'Universitätsklinikum Lübeck', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '41063', 'city': 'Mönchengladbach', 'country': 'Germany', 'facility': 'Krankenhaus St. Franziskus, Medizinische Klinik II', 'geoPoint': {'lat': 51.18539, 'lon': 6.44172}}, {'zip': '33098', 'city': 'Paderborn', 'country': 'Germany', 'facility': 'St. Vincenz-Krankenhaus GmbH', 'geoPoint': {'lat': 51.71905, 'lon': 8.75439}}, {'zip': '26871', 'city': 'Papenburg', 'country': 'Germany', 'facility': 'Kardiologische Praxis', 'geoPoint': {'lat': 53.07769, 'lon': 7.41516}}, {'zip': '49610', 'city': 'Quakenbrück', 'country': 'Germany', 'facility': 'Christl. Krankenhaus Quakenbrück', 'geoPoint': {'lat': 52.67502, 'lon': 7.94983}}, {'zip': '45661', 'city': 'Recklinghausen', 'country': 'Germany', 'facility': 'Elisabeth Krankenhaus GmbH', 'geoPoint': {'lat': 51.61379, 'lon': 7.19738}}, {'zip': '21465', 'city': 'Reinbek', 'country': 'Germany', 'facility': 'St. Adolf-Stift', 'geoPoint': {'lat': 53.51703, 'lon': 10.2488}}, {'zip': '01587', 'city': 'Riesa', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis Dr. Stenzel/Dr. Ebert', 'geoPoint': {'lat': 51.30777, 'lon': 13.29168}}, {'zip': '54292', 'city': 'Trier', 'country': 'Germany', 'facility': 'Evangelisches Elisabeth Krankenhaus', 'geoPoint': {'lat': 49.75565, 'lon': 6.63935}}, {'zip': '41747', 'city': 'Viersen', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis Drs. Schley, Burkhard-Meier, Schemeitat', 'geoPoint': {'lat': 51.25435, 'lon': 6.39441}}, {'zip': '97080', 'city': 'Würzburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Würzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Yan Chai Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': '58100', 'city': 'Holon', 'country': 'Israel', 'facility': 'Wolfson Medical Center', 'geoPoint': {'lat': 32.01034, 'lon': 34.77918}}, {'zip': '83331', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Nemocnica Ministerstva Obrany', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '04011', 'city': 'Košice', 'country': 'Slovakia', 'facility': 'VUSCH East Slovak Cardiology Institute, Arytmology', 'geoPoint': {'lat': 48.71441, 'lon': 21.25802}}, {'zip': 'E-46009', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitario La Fé', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Uwe Wiegand, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sana-Klinikum Remscheid, 42859 Remscheid, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotronik SE & Co. KG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}