Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-26 @ 7:22 PM
Study NCT ID:
NCT00839566
Status:
TERMINATED
Last Update Posted:
2025-07-03
First Post:
2009-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PAF-HEFT (Permanent Atrial Fibrillation in Heart Failure Trial)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006339', 'term': 'Heart Rate'}], 'ancestors': [{'id': 'D055986', 'term': 'Vital Signs'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006439', 'term': 'Hemodynamics'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Number of eligible patients too small.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2009-01-13', 'studyFirstSubmitQcDate': '2009-02-06', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'End systolic left ventricular diameter', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'NYHA-Class, Echo-parameters, ECG-parameters, VO2 max,6 minutes hallwalk-test', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'Heart Failure'], 'conditions': ['Atrial Fibrillation', 'Heart Failure']}, 'descriptionModule': {'briefSummary': 'Examination of CRT efficacy in patients with progressive heart failure and atrial fibrillation at the same time'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* LVEF \\<35%\n* QRS time ≥150ms LBB\n* NYHA classification ≥ NYHA III\n* permanent (\\> 6 months) Atrial Fibrillation\n* sinus rhythm (control group)\n* Condition after Implantation of a Medtronic CRT device\n* written informed consent\n\nExclusion Criteria:\n\n* exchange of the current CRT device\n* mitral incompetence (2. degree)\n* no compliance\n* participation in another study\n* pregnancy\n* patients with AV node\n* patients after heart transplant or those who are on the transplant list'}, 'identificationModule': {'nctId': 'NCT00839566', 'acronym': 'PAF-HEFT', 'briefTitle': 'PAF-HEFT (Permanent Atrial Fibrillation in Heart Failure Trial)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Rhythm and Heart Failure'}, 'officialTitle': 'Permanent Atrial Fibrillation in Heart Failure Trial', 'orgStudyIdInfo': {'id': 'CEN_G_CA_9'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AV ablation', 'interventionNames': ['Procedure: Ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rate control', 'description': 'Rate control by drugs', 'interventionNames': ['Other: Rate Control']}, {'type': 'NO_INTERVENTION', 'label': 'Sinus rhythm'}], 'interventions': [{'name': 'Ablation', 'type': 'PROCEDURE', 'description': 'AV-node ablation', 'armGroupLabels': ['AV ablation']}, {'name': 'Rate Control', 'type': 'OTHER', 'description': 'Rate control by drug', 'armGroupLabels': ['Rate control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44534', 'city': 'Lünen', 'country': 'Germany', 'facility': 'Professor Dr. med. Christian Perings', 'geoPoint': {'lat': 51.61634, 'lon': 7.52872}}], 'overallOfficials': [{'name': 'Christian Perings, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'marien Hospital Luenen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not applicable as NO is selected above for \'Plan to share IPD?"'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}