Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-27 @ 6:17 PM
Study NCT ID:
NCT00296166
Status:
TERMINATED
Last Update Posted:
2010-09-02
First Post:
2006-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Catheter Ablation Versus Thoracoscopic Ablation to Patients With Permanent Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'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': 'D017115', 'term': 'Catheter Ablation'}], 'ancestors': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}, {'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'whyStopped': 'Patients with permanent AF are seldomly symptomatic enough to justify intervention. We decided to stop inclusion due to low recruitment rate.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-07', 'completionDateStruct': {'date': '2010-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-09-01', 'studyFirstSubmitDate': '2006-02-23', 'studyFirstSubmitQcDate': '2006-02-23', 'lastUpdatePostDateStruct': {'date': '2010-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of sinus rhythm', 'timeFrame': 'after 6 months from treatment'}], 'secondaryOutcomes': [{'measure': 'complications', 'timeFrame': 'during 12 months from treatment'}, {'measure': 'cost-effectiveness', 'timeFrame': 'during 12 months from treatment'}, {'measure': 'structural changes (evaluated by echocardiography)', 'timeFrame': 'during 12 months from treatment'}, {'measure': 'p-BNP', 'timeFrame': 'during 12 months from treatment'}, {'measure': 'inflammatory markers', 'timeFrame': 'during 12 months from treatment'}, {'measure': 'atrial fibrillation burden evaluated by Holter monitoring', 'timeFrame': 'at 6 months from treatment'}, {'measure': 'exercise performance', 'timeFrame': 'at 3 months from treatment'}, {'measure': 'Quality of life', 'timeFrame': 'at 3 months from treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Atrial fibrillation', 'Permanent Atrial fibrillation', 'catheter ablation', 'thoracoscopy', 'Arrhythmia', 'Heart'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Patents with atrial fibrillation can be treated with the purpose of curing the arrhythmia.This may be achieved by catheter ablation and Maze surgery where the latter includes open heart surgery.\n\nBy catheter ablation the arrhythmia can be cured in about 70 % of patients who have episodes of atrial fibrillation. In patients with permanent atrial fibrillation the results are not as good.\n\nWe will compare a conventional ablation approach where lesions are created on the inside of the heart with a thoracoscopic approach where the lesions are created from the outside of the heart.', 'detailedDescription': 'Patients with permanent atrial fibrillation will be considered for randomisation Patients will be randomised to either conventional endocardial catheter ablation or epicardial thoracoscopic ablation.\n\nObjectives of study:\n\nPrimary endpoint:presence of sinus rhythm after 6 months Secondary endpoints: complications, cost-effectiveness, structural changes (evaluated by echocardiography), p-BNP and inflammatory markers, atrial fibrillation burden evaluated by Holter monitoring'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Permanent atrial fibrillation documented on at least 2 ecg´s with more than 1 month between ecg´s. The diagnosis is verified on Holter.\n* All patients have symptoms or do not tolerate rate control treatment.\n\nExclusion Criteria:\n\n* Psychiatric disease or suspicion of incapability to give informed concent\n* Females with birth giving potential\n* Previous heart surgery\n* Previous ablation for atrial fibrillation\n* Life expectance less than 1 year\n* Congenital heart disease\n* Expected need for heart surgery\n* Heart failure (NYHA class IV)\n* Inability to be treated with anticoagulation\n* In case of previous deep venous thromboembolism og stroke the investigators will individually consider if the patient is suitable for inclusion.'}, 'identificationModule': {'nctId': 'NCT00296166', 'briefTitle': 'Catheter Ablation Versus Thoracoscopic Ablation to Patients With Permanent Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'A Randomized Study That Will Show the Effects of Catheter Ablation Compared to the Effects of Thoracoscopic Ablation to Patients With Permanent Atrial Fibrillation.', 'orgStudyIdInfo': {'id': 'KAT-SKOPI study'}, 'secondaryIdInfos': [{'id': 'KF - 01-284215'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Catheter ablation', 'type': 'PROCEDURE'}, {'name': 'Thoracoscopic epicardial ablation', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Risghospitalet,', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Jesper H Svendsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}}}}