Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-01-05 @ 5:20 PM
Study NCT ID:
NCT00448656
Status:
COMPLETED
Last Update Posted:
2012-06-19
First Post:
2007-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Atrial Fibrillation by Minimal Invasive Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], '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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-18', 'studyFirstSubmitDate': '2007-03-15', 'studyFirstSubmitQcDate': '2007-03-15', 'lastUpdatePostDateStruct': {'date': '2012-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sinus rhythm at end of follow-up (6 months)', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'absence of permanent atrial fibrillation at end of follow-up', 'timeFrame': '6 months'}, {'measure': 'absence of any symptomatic atrial fibrillation', 'timeFrame': '6 months'}, {'measure': 'atrial volume and contraction at end of follow-up', 'timeFrame': '6 months'}, {'measure': 'left ventricular diameters and function at end of follow-up', 'timeFrame': '6 months'}, {'measure': 'thromboembolism', 'timeFrame': '6 months'}, {'measure': 'pulmonary vein stenosis', 'timeFrame': '6 months'}, {'measure': 'immediate postoperative complications (and related sequelae)', 'timeFrame': 'directly post-operative'}, {'measure': 'surgical procedure time and total epicardial ablation time', 'timeFrame': 'directly post-operative'}, {'measure': 'any pacemaker implantation', 'timeFrame': '6 months'}, {'measure': 'mortality', 'timeFrame': '6 months'}, {'measure': 'bleeding', 'timeFrame': '6 months'}, {'measure': 'hospitalization for heart failure', 'timeFrame': '6 months'}, {'measure': 'antiarrhythmic drugs during follow-up', 'timeFrame': '6 months'}, {'measure': 'electrical cardioversions during follow-up', 'timeFrame': '6 months'}, {'measure': 're-ablations', 'timeFrame': '6 months'}, {'measure': 'syncope', 'timeFrame': '6 months'}, {'measure': 'quality of life and specific arrhythmia symptoms', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'epicardial ablation pulmonary veins', 'video assisted thoracic surgery'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '19812047', 'type': 'DERIVED', 'citation': 'Klinkenberg TJ, Ahmed S, Ten Hagen A, Wiesfeld AC, Tan ES, Zijlstra F, Van Gelder IC. Feasibility and outcome of epicardial pulmonary vein isolation for lone atrial fibrillation using minimal invasive surgery and high intensity focused ultrasound. Europace. 2009 Dec;11(12):1624-31. doi: 10.1093/europace/eup299. Epub 2009 Oct 6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the feasability of a new epicardial and minimal invasive ablation technique of the left atrium isolating the pulmonary veins for prevention of atrial fibrillation recurrences in patients with antiarrhythmic drug refractory lone atrial fibrillation.', 'detailedDescription': 'Atrial fibrillation is a major health problem.Despite adequate treatment of underlying heart disease, rhythm control is unsuccessful in almost half of patients, also in patients with lone atrial fibrillation.If patients remain highly symptomatic, a non-pharmacological approach may be considered including pulmonary vein isolation and Cox maze III surgery. Maze III surgery has high succes rates, however it includes major cardiac surgery with substantial risk of complications. New surgical strategies for symptomatic lone atrial fibrillation focus on minimal invasive off-pump procedures omitting cardiopulmonary bypass (and thus lowering the complication rate), while taking advantage of an easier approach to the ablation site and a shorter procedure time. Epicardial surgical ablation isolating pulmonary veins by high intensity focused ultrasound performed off-pump by Video Assisted Thoracic Surgery (VATS)may be a promising treatment option. In this pilot study, we aim to study the feasibility of this new surgical ablation approach in patients with lone atrial fibrillation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '76 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Documented symptomatic lone paroxysmal or persistent atrial fibrillation, which either convert spontaneously or can be terminated with antiarrhythmic drugs or by an electrical cardioversion.\n2. The patient had a least one episode of persistent atrial fibrillation or three episodes of paroxysmal atrial fibrillation during the last three months.\n3. Duration present episode persistent atrial fibrillation less then one year.\n4. The patient has been treated with at least two different antiarrhythmic drugs (class I-IV) of which at least one belongs to class I or III.\n5. The patient will sign and date the written informed consent prior to study participation.\n\nExclusion Criteria:\n\n1. Age \\<18 and \\>76 years.\n2. Contraindications for oral anticoagulation.\n3. Signs of sick sinus syndrome or AV conduction disturbances (i.e. symptomatic bradycardia or asystole \\> 3 seconds or escape rate \\< 40 beats per minute in awake symptom-free patients).\n4. Permanent atrial fibrillation defined as atrial fibrillation continuously present and not convertible to sinus rhythm by an electrical cardioversion or antiarrhythmic drugs.\n5. Previous transvenous pulmonary vein isolation, Maze surgery, or other cardiac surgery.\n6. Heart failure defined as NYHA class III-IV heart failure.\n7. Previously implanted intracardiac device or has current or foreseen pacemaker, internal cardioverter defibrillator (ICD) and/ or cardiac resynchronization therapy.\n8. Clinically relevant valvular heart disease.\n9. Coronary artery disease or an old myocardial infarction\n10. Acute or chronic infection.\n11. Untreated clinical hypo- or hyperthyroidism or \\< 3 months euthyroidism.\n12. Uncontrolled hypertension, defined as a systolic blood pressure \\> 160 mm Hg and/or a diastolic blood pressure \\> 95 mm Hg (anti-hypertensive treatment is allowed).\n13. The patient has a concurrent medical condition (i.e. alcohol or drug abuse or a severe progressive extracardiac disease) or is unlikely to comply with the protocol.'}, 'identificationModule': {'nctId': 'NCT00448656', 'acronym': 'ABOLISH-AF', 'briefTitle': 'Treatment of Atrial Fibrillation by Minimal Invasive Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Treatment of Atrial Fibrillation by Minimal Invasive Epicardial Pulmonary Vein Isolation: The ABOLISH-AF Study', 'orgStudyIdInfo': {'id': 'p06.0550l'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ablation of pulmonary veins by video assisted thoracic surgery', 'type': 'PROCEDURE', 'otherNames': ['Epicor'], 'description': 'epicardial ablation using HIFU'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9700 RB', 'city': 'Groningen', 'state': 'Provincie Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Isabelle C. Vam Gelder, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.dr.', 'investigatorFullName': 'I.C. Van Gelder', 'investigatorAffiliation': 'University Medical Center Groningen'}}}}