Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-03-09 @ 7:21 AM
Study NCT ID:
NCT00547794
Status:
TERMINATED
Last Update Posted:
2019-02-04
First Post:
2007-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AVJ Ablation Followed by Resynchronization Therapy in Patients With CHF and AF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D006333', 'term': 'Heart Failure'}], '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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'whyStopped': 'Difficulty in patient enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-01', 'studyFirstSubmitDate': '2007-10-19', 'studyFirstSubmitQcDate': '2007-10-22', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exercise duration', 'timeFrame': '12 month post implant'}], 'secondaryOutcomes': [{'measure': 'Quality of Life (QOL) via Minnesota Living With Heart Failure (MLWH) questionnaire', 'timeFrame': '12 month post implant'}, {'measure': 'NYHA Class Progression', 'timeFrame': '12 month post implant'}, {'measure': 'LVEF', 'timeFrame': '12 month post implant'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Atrial Fibrillation', 'Congestive Heart Failure']}, 'referencesModule': {'references': [{'pmid': '17038140', 'type': 'BACKGROUND', 'citation': 'Hamdan MH, Freedman RA, Gilbert EM, Dimarco JP, Ellenbogen KA, Page RL. Atrioventricular junction ablation followed by resynchronization therapy in patients with congestive heart failure and atrial fibrillation (AVERT-AF) study design. Pacing Clin Electrophysiol. 2006 Oct;29(10):1081-8. doi: 10.1111/j.1540-8159.2006.00502.x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine if the combination of AVJ ablation followed by BiV pacing significantly improves functional status and exercise capacity compared to pharmacologic rate control in patients with chronic AF and depressed ejection fraction, regardless of rate or QRS duration.', 'detailedDescription': '* This is a prospective, randomized, double blinded, multicenter study\n* Patients meeting all the enrollment criteria are screened at enrollment and randomized to Group 1 (Pharmacological therapy + Single Chamber ICD) or Group 2 (AVJ Ablation + CRT-D)\n* Screened patients are implanted with a FDA approved SJM ICD/CRT-D with compatible lead system\n* Patients are followed at 1, 3, 6 and 12 months post implant\n* Total # of centers - 20 centers\n* Sample size - 180 patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with history of permanent AF and CHF', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic permanent AF\n* Class I or II indication for ICD\n* LVEF ≤ 35% within 6 months\n* NYHA class II or III with a history of CHF\n* Maximal tolerated drug therapy for CHF and rate control with a stable regimen for ≥ 30 days\n* Ability to independently comprehend and complete a QoL questionnaire\n* Ability to give informed consent for study participation and willingness and ability to comply with prescribed follow-up tests and scheduled evaluations\n\nExclusion Criteria:\n\n* Paroxysmal or persistent AF\n* Class I indication for pacing (including AVJ ablation for poor rate control)\n* Ability to walk ≥ 450 meters in 6 minutes\n* Musculoskeletal disorders that prohibit the completion of a 450 meters walk\n* NYHA class I or IV at the time of enrollment\n* A contraindication to taking Coumadin therapy\n* History of myocardial infarction, percutanous coronary intervention, or CABG in the past 30 days\n* History of mitral valve surgery\n* Prior attempts for cardiac resynchronization therapy\n* The presence of an existing coronary sinus lead or epicardial lead\n* Life expectancy \\< 1year\n* Age \\< 18 yrs\n* Current participation in other clinical studies except registry trials\n* Use of calcium channel blockers\n* Pregnancy\n* Inability to give informed consent'}, 'identificationModule': {'nctId': 'NCT00547794', 'acronym': 'AVERT-AF', 'briefTitle': 'AVJ Ablation Followed by Resynchronization Therapy in Patients With CHF and AF', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'AVERT-AF: Atrio-VEntricular Junction Ablation Followed by Resynchronization Therapy in Patients With Congestive Heart Failure and Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'CRD 310'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CRT-D + AVJ Ablation'}, {'label': 'Single-Chamber ICD + Pharmacological Therapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Mohamed Hamdan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}