Ignite Creation Date:
2025-12-26 @ 10:33 AM
Ignite Modification Date:
2026-03-04 @ 11:46 AM
Study NCT ID:
NCT00627328
Status:
COMPLETED
Last Update Posted:
2008-03-03
First Post:
2007-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Atrial High Rate Episodes in Pacemaker Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D054537', 'term': 'Atrioventricular Block'}, {'id': 'D001919', 'term': 'Bradycardia'}, {'id': 'D012804', 'term': 'Sick Sinus Syndrome'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006327', 'term': 'Heart Block'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D001146', 'term': 'Arrhythmia, Sinus'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 427}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'completionDateStruct': {'date': '2004-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-02-22', 'studyFirstSubmitDate': '2007-12-26', 'studyFirstSubmitQcDate': '2008-02-22', 'lastUpdatePostDateStruct': {'date': '2008-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-03', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Physiologic Pacing', 'Dual Chamber Pacing', 'Atrioventricular Block', 'Bradycardia', 'Sick Sinus Syndrome'], 'conditions': ['Arrhythmia', 'Atrial Fibrillation', 'Atrioventricular Block', 'Bradycardia', 'Sick Sinus Syndrome']}, 'referencesModule': {'references': [{'pmid': '17584266', 'type': 'BACKGROUND', 'citation': 'Ghali JK, Orlov MV, Araghi-Niknam M, Sherfesee L, Hettrick DA. The influence of symptoms and device detected atrial tachyarrhythmias on medical management: insights from A-HIRATE. Pacing Clin Electrophysiol. 2007 Jul;30(7):850-7. doi: 10.1111/j.1540-8159.2007.00772.x.'}, {'pmid': '17367361', 'type': 'RESULT', 'citation': 'Orlov MV, Ghali JK, Araghi-Niknam M, Sherfesee L, Sahr D, Hettrick DA; Atrial High Rate Trial Investigators. Asymptomatic atrial fibrillation in pacemaker recipients: incidence, progression, and determinants based on the atrial high rate trial. Pacing Clin Electrophysiol. 2007 Mar;30(3):404-11. doi: 10.1111/j.1540-8159.2007.00682.x.'}]}, 'descriptionModule': {'briefSummary': 'Prospective study assessing the incidence of atrial high rate episodes (AHRE) in pacemaker patients with and without previously diagnosed AT.', 'detailedDescription': "The purpose of this study is to assess the incidence of fast heart rates that originate in the upper chamber of the heart (atrial tachyarrhythmias) in pacemaker patients that have not been previously diagnosed with this condition. The study will also look at how the diagnostic feature in the pacemaker that detects atrial tachyarrhythmias helps physicians with the medical management of patients' heart rhythm."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Prospective study with patients undergoing a Medtronic Kappa DR 700 or Medtronic Kappa 900 DR implant, for approved indications.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing a Medtronic Kappa DR 700 or Medtronic Kappa 900 DR implant, for approved indications\n* No previous history of pacemaker implantation\n* Patients 50 years of age or older\n\nExclusion Criteria:\n\n* Patients with a history of atrial tachyarrhythmias (primary arm of study)\n* Patients with medical conditions that would limit study participation\n* Patients inaccessible for follow-up at the study center\n* Patients incapable of providing Informed Consent\n* Patients with NYHA classification of IV\n* Patients with a history of neurocardiogenic syncope, long QT syndrome, or Hypertrophic Obstructive Cardiomyopathy (HOCM)\n* Patients taking Sotalol or Amiodorone\n* Patients with a history of a prior ICD or pacemaker implantation.'}, 'identificationModule': {'nctId': 'NCT00627328', 'briefTitle': 'The Atrial High Rate Episodes in Pacemaker Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Rhythm and Heart Failure'}, 'officialTitle': 'The Atrial High Rate Episodes (A-HIRATE) in Pacemaker Patients', 'orgStudyIdInfo': {'id': '163'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'pacemaker patients with previously diagnosed AT.'}, {'label': '2', 'description': 'pacemaker patients without previously diagnosed AT.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'Fresno', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'city': 'Glendale', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Hammond', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 41.58337, 'lon': -87.50004}}, {'city': 'Hobart', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 41.53226, 'lon': -87.25504}}, {'city': 'Munster', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 41.56448, 'lon': -87.51254}}, {'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'city': 'Marrero', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 29.89937, 'lon': -90.10035}}, {'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'city': 'Salisbury', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 38.36067, 'lon': -75.59937}}, {'city': 'West Roxbury', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.27926, 'lon': -71.1495}}, {'city': 'Saint Cloud', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 45.5608, 'lon': -94.16249}}, {'city': 'Livingston', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.79593, 'lon': -74.31487}}, {'city': 'Patterson', 'state': 'New Jersey', 'country': 'United States'}, {'city': 'Flushing', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.76538, 'lon': -73.81736}}, {'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'city': 'Gastonia', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.26208, 'lon': -81.1873}}, {'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'city': 'Willimington', 'state': 'North Carolina', 'country': 'United States'}, {'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'city': 'Bethlehem', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}, {'city': 'Mechanicsburg', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.21426, 'lon': -77.00859}}, {'city': 'Scranton', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 41.40916, 'lon': -75.6649}}, {'city': 'Wynnewood', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.00289, 'lon': -75.27074}}, {'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}, {'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'city': 'Ashford', 'country': 'Australia', 'geoPoint': {'lat': -34.94859, 'lon': 138.57457}}, {'city': 'Ballarat', 'country': 'Australia', 'geoPoint': {'lat': -37.56622, 'lon': 143.84957}}, {'city': 'Bedford Park', 'country': 'Australia', 'geoPoint': {'lat': -35.02204, 'lon': 138.56815}}, {'city': 'Lille', 'country': 'France', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Rouen', 'country': 'France', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'overallOfficials': [{'name': 'M. V. Orlov, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts University School of Medicine'}, {'name': 'J.K. Ghali, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Louisiana State University Health Sciences Center in New Orleans'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Diane Sahr', 'oldOrganization': 'CRDM Clincial Research'}}}}