Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-05 @ 6:08 PM
Study NCT ID:
NCT00703157
Status:
TERMINATED
Last Update Posted:
2017-05-16
First Post:
2008-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Surgical or Catheter Ablation of Lone Atrial Fibrillation (AF) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ber.kleijnen@medtronic.com', 'phone': '+31 (0) 43 356 6566', 'title': 'Ber Kleijnen', 'organization': 'Medtronic Bakken Research Center, Coronary and Structural Heart Disease Management'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study stopped early, prior to meeting the target number of subjects per group. The reported results and conclusions are based on these limited data.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group', 'eventGroups': [{'id': 'EG000', 'title': 'Catheter', 'description': 'Catheter Ablation', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 3, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Surgery', 'description': 'Surgical Ablation', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 8, 'seriousNumAtRisk': 26, 'deathsNumAffected': 1, 'seriousNumAffected': 15}, {'id': 'EG002', 'title': 'All Randomized Subjects', 'description': 'All Randomized Subjects, regardless of randomization group', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 11, 'seriousNumAtRisk': 52, 'deathsNumAffected': 1, 'seriousNumAffected': 25}], 'otherEvents': [{'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'seriousEvents': [{'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cerebralvascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Postoperative fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Arteriospasm coronary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cardiac procedure complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'External Cephalic Version', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Parapalegia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cardiac ablation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Blindness transient', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': "Dressler's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Prinzmetal angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Sternotomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Subcutaneous emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in AF Burden After Ablation Therapy Measured With REVEAL-XT Implantable Device.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Catheter', 'description': 'Catheter Ablation'}, {'id': 'OG001', 'title': 'Surgery', 'description': 'Surgical Ablation'}, {'id': 'OG002', 'title': 'All Subjects', 'description': 'All Subjects, regardless of randomization group'}], 'classes': [{'title': 'Pre-ablation', 'categories': [{'measurements': [{'value': '7.6', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '8.7', 'groupId': 'OG001'}, {'value': '7.8', 'spread': '8.0', 'groupId': 'OG002'}]}]}, {'title': 'Blanking Period', 'categories': [{'measurements': [{'value': '1.6', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '6.1', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '5.3', 'groupId': 'OG002'}]}]}, {'title': 'Absolute Change Pre to Blanking', 'categories': [{'measurements': [{'value': '-6.0', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '7.2', 'groupId': 'OG001'}, {'value': '-5.1', 'spread': '6.7', 'groupId': 'OG002'}]}]}, {'title': 'Post-Ablation', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '5.5', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '4.1', 'groupId': 'OG002'}]}]}, {'title': 'Absolute Change Blanking to Post', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '5.5', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '4.5', 'groupId': 'OG002'}]}]}, {'title': 'Percent Change Pre to Post', 'categories': [{'measurements': [{'value': '-77.8', 'spread': '68.4', 'groupId': 'OG000'}, {'value': '-70.8', 'spread': '65.1', 'groupId': 'OG001'}, {'value': '-74.2', 'spread': '66.1', 'groupId': 'OG002'}]}]}, {'title': 'Absolute Change Pre to Post', 'categories': [{'measurements': [{'value': '-7.1', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '-5.8', 'spread': '9.1', 'groupId': 'OG001'}, {'value': '-6.5', 'spread': '8.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through 3-6 months post-ablation', 'description': 'AF Burden is defined as the percentage of time during the follow-up period that a subject is in AF, as measured by the REVEAL-XT implantable device.', 'unitOfMeasure': 'percentage of time in AF', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Treatment Failures Requiring Redo or Alternative Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Catheter', 'description': 'Catheter Ablation'}, {'id': 'OG001', 'title': 'Surgery', 'description': 'Surgical Ablation'}, {'id': 'OG002', 'title': 'All Subjects', 'description': 'All Subjects, regardless of randomization group'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Time from procedure until 6 months post-ablation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Adverse Events, Associated With the Ablation Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Catheter', 'description': 'Catheter Ablation'}, {'id': 'OG001', 'title': 'Surgery', 'description': 'Surgical Ablation'}, {'id': 'OG002', 'title': 'All Subjects', 'description': 'All Subjects, regardless of randomization group'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Time from procedure', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mortality and Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Catheter', 'description': 'Catheter Ablation'}, {'id': 'OG001', 'title': 'Surgery', 'description': 'Surgical Ablation'}, {'id': 'OG002', 'title': 'All Subjects', 'description': 'All Subjects, regardless of randomization group'}], 'classes': [{'title': 'Any Hospitalization', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}]}, {'title': 'Any Procedure-Related Hospitalization', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Time from procedure until 24 months post-ablation', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration, Burden and Costs of Treatment Procedures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Catheter', 'description': 'Catheter Ablation'}, {'id': 'OG001', 'title': 'Surgery', 'description': 'Surgical Ablation'}], 'timeFrame': 'Through 24 months post- ablation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected'}, {'type': 'SECONDARY', 'title': 'Reduced Number, Duration and Severity of AF Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Catheter', 'description': 'Catheter Ablation'}, {'id': 'OG001', 'title': 'Surgery', 'description': 'Surgical Ablation'}], 'timeFrame': 'Through 24 months post-ablation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected'}, {'type': 'SECONDARY', 'title': 'Symptoms Associated With Atrial Arrhythmias', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Catheter', 'description': 'Catheter Ablation'}, {'id': 'OG001', 'title': 'Surgery', 'description': 'Surgical Ablation'}], 'timeFrame': 'Through 24 months post-ablation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected'}, {'type': 'SECONDARY', 'title': 'Occurences of Treatment of Arrhythmic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Catheter', 'description': 'Catheter Ablation'}, {'id': 'OG001', 'title': 'Surgery', 'description': 'Surgical Ablation'}], 'timeFrame': 'Through 24 months post-ablation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected'}, {'type': 'SECONDARY', 'title': 'Assessment of AF Burden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Catheter', 'description': 'Catheter Ablation'}, {'id': 'OG001', 'title': 'Surgery', 'description': 'Surgical Ablation'}], 'timeFrame': 'Through 24 months post-ablation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected'}, {'type': 'SECONDARY', 'title': 'Reduced Anti-arrhythmic Drug Requirement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Catheter', 'description': 'Catheter Ablation'}, {'id': 'OG001', 'title': 'Surgery', 'description': 'Surgical Ablation'}], 'timeFrame': 'Through 24 months post-ablation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected'}, {'type': 'SECONDARY', 'title': 'Left Atrial Dimension and Contractility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Catheter', 'description': 'Catheter Ablation'}, {'id': 'OG001', 'title': 'Surgery', 'description': 'Surgical Ablation'}], 'timeFrame': 'Through 24 months post-ablation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Catheter', 'description': 'Catheter Ablation'}, {'id': 'FG001', 'title': 'Surgery', 'description': 'Surgical Ablation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': '6 Months FU', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': '24 Months FU', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'source data permanently lost/ other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Eighty (80) subjects were enrolled, of whom 52 were randomized. A Reveal XT Implantable device was implanted in all subjects after Informed Consent. The subjects were followed for a minimum of 1 week and a maximum of 6 months. If the subject demonstrated a minimum of 10% AF burden during this period and had complaints, the subject was randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Catheter', 'description': 'Catheter Ablation'}, {'id': 'BG001', 'title': 'Surgery', 'description': 'Surgical Ablation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61', 'spread': '7', 'groupId': 'BG000'}, {'value': '55', 'spread': '9', 'groupId': 'BG001'}, {'value': '58', 'spread': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'NYHA Class', 'classes': [{'title': 'I', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}, {'title': 'II', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The New York Heart Association (NYHA) Functional Classification places patients in one of four categories based on their limitations during physical activity.The limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina.\n\nClass I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).\n\nClass II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'whyStopped': 'Enrollments slowed down significantly, despite several attempts to re-launch.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-15', 'studyFirstSubmitDate': '2008-06-19', 'resultsFirstSubmitDate': '2017-03-22', 'studyFirstSubmitQcDate': '2008-06-20', 'lastUpdatePostDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-15', 'studyFirstPostDateStruct': {'date': '2008-06-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in AF Burden After Ablation Therapy Measured With REVEAL-XT Implantable Device.', 'timeFrame': 'Baseline through 3-6 months post-ablation', 'description': 'AF Burden is defined as the percentage of time during the follow-up period that a subject is in AF, as measured by the REVEAL-XT implantable device.'}], 'secondaryOutcomes': [{'measure': 'Treatment Failures Requiring Redo or Alternative Therapy', 'timeFrame': 'Time from procedure until 6 months post-ablation'}, {'measure': 'Number of Subjects With Adverse Events, Associated With the Ablation Procedure', 'timeFrame': 'Time from procedure'}, {'measure': 'Mortality and Hospitalization', 'timeFrame': 'Time from procedure until 24 months post-ablation'}, {'measure': 'Duration, Burden and Costs of Treatment Procedures', 'timeFrame': 'Through 24 months post- ablation'}, {'measure': 'Reduced Number, Duration and Severity of AF Symptoms', 'timeFrame': 'Through 24 months post-ablation'}, {'measure': 'Symptoms Associated With Atrial Arrhythmias', 'timeFrame': 'Through 24 months post-ablation'}, {'measure': 'Occurences of Treatment of Arrhythmic Episodes', 'timeFrame': 'Through 24 months post-ablation'}, {'measure': 'Assessment of AF Burden', 'timeFrame': 'Through 24 months post-ablation'}, {'measure': 'Reduced Anti-arrhythmic Drug Requirement', 'timeFrame': 'Through 24 months post-ablation'}, {'measure': 'Left Atrial Dimension and Contractility', 'timeFrame': 'Through 24 months post-ablation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '31236689', 'type': 'DERIVED', 'citation': 'Buist TJ, Adiyaman A, Beukema RJ, Smit JJJ, Delnoy PPHM, Hemels MEW, Sie HT, Ramdat Misier AR, Elvan A. Quality of life after catheter and minimally invasive surgical ablation of paroxysmal and early persistent atrial fibrillation: results from the SCALAF trial. Clin Res Cardiol. 2020 Feb;109(2):215-224. doi: 10.1007/s00392-019-01504-z. Epub 2019 Jun 24.'}, {'pmid': '30354411', 'type': 'DERIVED', 'citation': 'Adiyaman A, Buist TJ, Beukema RJ, Smit JJJ, Delnoy PPHM, Hemels MEW, Sie HT, Ramdat Misier AR, Elvan A. Randomized Controlled Trial of Surgical Versus Catheter Ablation for Paroxysmal and Early Persistent Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2018 Oct;11(10):e006182. doi: 10.1161/CIRCEP.118.006182.'}]}, 'descriptionModule': {'briefSummary': 'Prospective randomized interventional trial comparing the efficacy of circumferential pulmonary vein ostia ablation using surgical versus catheter techniques in the treatment of paroxysmal atrial fibrillation. Success rate determined by REVEAL-XT (AF implantable monitoring device).', 'detailedDescription': 'Title: Surgical or Catheter Ablation in patients with Lone Atrial Fibrillation: determination of acute and long term SUCCESS (SCALAF-success trial).\n\nBackground: Anti-arrhythmic drugs are used in daily practice to treat patients with paroxysmal idiopatic AF. Often the origin of the AF can be found in the muscle sleeves running up the pulmonary veins. Drug treatment is not always successful and prone to evoke negative side effects. The surgical MAZE procedure was applied in the past, but this is a time consuming, cumbersome technique, often associated with significant complications. Cardiac radio-frequency ablation offers an alternative, easy and less time consuming treatment: lesions prevent normal electrical wave front propagation and might stop the continuation of atrial fibrillation wave fronts. Ablation can be implemented by use of special catheters inserted via the groin or using the Medtronic Cardioblate® Surgical Ablation System applied via minimal invasive surgical techniques.\n\nPurpose: Compare the effectiveness of pulmonary vein isolation achieved via catheter or via surgical ablation techniques to treat patients with paroxysmal lone AF.\n\nStudy design: A prospective, randomized multi-center interventional study.\n\nPatients: Patients suffering from paroxysmal idiopatic AF (no associated or underlying structural heart disease) complying with following inclusion criteria:\n\n* minimally one documented AF-episode in the last 6 months;\n* refractory to at least 2 class I or III anti-arrhythmic drugs;\n* age \\> 18 year\n\nIntervention: Patients are randomized to either the surgical or the catheter ablation group and receive the indicated treatment. During the critical assessment period, the patients are weaned from anti-arrhythmic medication.\n\nPrimary endpoint: Reduction in AF occurrence measured by the AF-burden parameter in the critical period between 3 and 6 months post-ablation. AF burden is measured automatically by means of the Reveal XT, implanted at study enrolment to document the baseline characteristics.\n\nSecondary endpoints:\n\n* Failure of therapy requiring re-interventions;\n* Duration, burden and costs of ablation procedures:\n* Reduction in frequency, duration and level of severity of AF symptoms;\n* Occurences of treatments of arrythmic episodes;\n* Assessment of AF burden during follow-up period\n* Symptoms associated with AF;\n* Reduced necessity of anti-arrhythmic or anticoagulant medication;\n* Left atrial dimensions and contractility\n* Adverse events associated with the ablation therapy;\n* Occurrence of other clinical adverse events (TIA, CVA, bleeds, tamponade, MI) at 3, 6, 12 and 24 months of follow up\n* Mortality and hospitalisation\n\nRisk assessment: Possible side effects : irregular heart rhythm, pericardial fluid, stroke, heart infarct, disturbances of the conduction system in the heart, local pain at the site of incisions, heart failure or reduced pump function of the heart.\n\nPossible benefits: Regulation of the heart rhythm without applying MAZE procedure or opening of the thorax. Reduction or relief from symptoms associated with AF. Partial or complete reduction of anti-arrhythmic medication. Control of anti-coagulant medication. Improved quality of life for the patients.\n\nVisits are planned at study entrance and Reveal XT implant (assessment at baseline, application of the ablation therapy), discharge from hospital, and at 3, 6, 12 and 24 months post-ablation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has documented Paroxysmal AF as defined by the ACC/AHA/ESC guidelines\n* Minimal one documented AF episode in the last 6 months\n* Refractory to minimal two Class I or III anti-arrhythmic drug\n* Age \\> 18 years\n* Signed and dated the Patient Informed Consent.\n* Patient can tolerate anti-coagulation therapy (Warfarin/Coumadin)\n\nExclusion Criteria:\n\n* Patient has a structural heart disease\n* Ejection fraction \\< 40 %\n* Echocardiographic evidence for a left atrium \\> 45 mm (parasternal axis)\n* Patients on amiodarone, or patients known to be intolerant for amiodarone\n* Dextrocardia, current endocarditis, systemic infection, renal failure\n* Patient has known cerebrovascular disease, including a history of stroke, CVA or TIA\n* Pregnancy at enrolment; or planned pregnancy within the follow up period\n* Patient has a life expectancy less than 1 year\n* The subject is participating in another device or drug study\n* The patient is unable and/or unwilling to cooperate with study procedures or required follow up visits\n* Echocardiographic (TTE) evidence for presence of left atrial thrombus\n* Previous (cardio-) thoracic surgery\n* Previous left atrial ablation\n* Patients with permanent or persistent AF'}, 'identificationModule': {'nctId': 'NCT00703157', 'acronym': 'SCALAF', 'briefTitle': 'Surgical or Catheter Ablation of Lone Atrial Fibrillation (AF) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiovascular'}, 'officialTitle': 'Surgical or Catheter Ablations in Patients With Lone Atrial Fibrillation: Determination of Acute and Long Term Success Rate (SCALAF Success Trial)', 'orgStudyIdInfo': {'id': 'BRC-CS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Arm 1: Catheter Ablation', 'interventionNames': ['Procedure: Catheter Ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Arm 2: Surgical Ablation.', 'interventionNames': ['Procedure: Surgical Ablation']}], 'interventions': [{'name': 'Catheter Ablation', 'type': 'PROCEDURE', 'description': 'Patients undergoing left atrial circumferential pulmonary vein ostia ablation.', 'armGroupLabels': ['1']}, {'name': 'Surgical Ablation', 'type': 'PROCEDURE', 'description': 'patients undergoing left atrial circumferential pulmonary vein ostia ablation via minimal invasive surgery.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8011 JW', 'city': 'Zwolle', 'country': 'Netherlands', 'facility': 'Isala Klinieken', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}], 'overallOfficials': [{'name': 'Hauw Sie, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Isala'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan or intention to share individual participant data (IPD)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}