Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 6:52 PM
Study NCT ID:
NCT00268294
Status:
COMPLETED
Last Update Posted:
2008-12-18
First Post:
2005-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Restoring Sinus Rhythm With Cardiac Resynchronization in Patients With Atrial Fibrillation (ReSync AF)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058406', 'term': 'Cardiac Resynchronization Therapy'}], 'ancestors': [{'id': 'D002304', 'term': 'Cardiac Pacing, Artificial'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-16', 'studyFirstSubmitDate': '2005-12-21', 'studyFirstSubmitQcDate': '2005-12-21', 'lastUpdatePostDateStruct': {'date': '2008-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the AF burden, frequency and duration of episodes when atrial therapies are ON vs. OFF.'}]}, 'conditionsModule': {'keywords': ['cardiac resynchronization therapy, atrial arrhythmia'], 'conditions': ['Heart Failure, Atrial Arrhythmia']}, 'descriptionModule': {'briefSummary': 'Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy may be prescribed.\n\nPeople who have a dangerously fast heart beat, or whose heart is at risk of stopping beating, may be in need of an electronic device called an implantable cardioverter defibrillator (ICD).\n\nAtrial tachyarrhythmia (AT) is the name for rapid beats in the upper chambers of the heart. People with AT may experience symptoms such as heart palpitations (a racing or pounding feeling in the chest), shortness of breath, dizziness, fatigue or weakness.\n\nThe purpose of this study is to characterize the impact of cardiac resynchronization therapy versus cardiac resynchronization therapy with atrial therapies on the incidence, duration and termination of atrial tachyarrhythmias.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with atrial fibrillation\n* Subjects with a heart beat that is too fast and who have been determined by a doctor to require an implantable cardioverter defibrillator (ICD) i.\n\nExclusion Criteria:\n\n* Subjects with a natural heart rate less than 30bpm'}, 'identificationModule': {'nctId': 'NCT00268294', 'briefTitle': 'Restoring Sinus Rhythm With Cardiac Resynchronization in Patients With Atrial Fibrillation (ReSync AF)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Rhythm and Heart Failure'}, 'officialTitle': 'Restoring Sinus Rhythm With Cardiac Resynchronization in Patients With Atrial Fibrillation', 'orgStudyIdInfo': {'id': '221'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cardiac Resynchronization Therapy', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '99437', 'city': 'Bad Berka', 'country': 'Germany', 'facility': 'Zentralklinik Bad Berka GmbH', 'geoPoint': {'lat': 50.89982, 'lon': 11.28245}}], 'overallOfficials': [{'name': 'Burkhard Huegl, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zentralklinik Bad Berka GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}]}}}