Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-02-28 @ 10:22 PM
Study NCT ID:
NCT01030705
Status:
COMPLETED
Last Update Posted:
2011-09-29
First Post:
2009-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Common Sensing and Right Ventricular Automatic Capture (COGNATE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001919', 'term': 'Bradycardia'}], '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-28', 'studyFirstSubmitDate': '2009-12-09', 'studyFirstSubmitQcDate': '2009-12-10', 'lastUpdatePostDateStruct': {'date': '2011-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bradycardia', 'pacemaker'], 'conditions': ['Bradycardia', 'Chronotropic Incompetence']}, 'descriptionModule': {'briefSummary': 'This study will collect data on features for future pacemakers via an external non-implantable system.', 'detailedDescription': 'COGNATE is an acute, confirmatory prospective, multi-center study designed to gather data on Brady and CRT-P indicated patients, with no restrictions on the type/brand of leads. This study will enroll up to 80 patients in up to 12 centers. Total duration of the study is expected to be 9 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are scheduled to receive either Pacemaker (dual chamber) or CRT-P devices based on physician discretion\n* Patients who are willing and capable of participating in all testing associated with this Clinical Investigation\n* Patients who are age 18 or above, or of legal age to give informed consent specific to state and national law\n\nExclusion Criteria:\n\n* Patient enrolled in any concurrent study, without Boston Scientific CRM written approval, that may confound the results of this study\n* Patients with a prosthetic mechanical tricuspid heart valve\n* Women who are pregnant'}, 'identificationModule': {'nctId': 'NCT01030705', 'acronym': 'COGNATE', 'briefTitle': 'Common Sensing and Right Ventricular Automatic Capture (COGNATE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Common Sensing and Right Ventricular Automatic Capture', 'orgStudyIdInfo': {'id': 'COGNATE'}}, 'contactsLocationsModule': {'locations': [{'zip': '52043', 'city': 'Cedar Rapids', 'state': 'Iowa', 'country': 'United States', 'facility': "St. Luke's Hospital", 'geoPoint': {'lat': 42.00833, 'lon': -91.64407}}, {'zip': '68526', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Nebraska Heart Institute', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center, Cardiac Electrophysiology', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '84107', 'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'facility': 'Intermountain Medical Center', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University Health System, Medical College of Virginia, MCV Physicians and Hospitals', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Samir Saba, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Health Care Conusltant'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Pittsburgh', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}