Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2026-03-01 @ 5:01 PM
Study NCT ID:
NCT02832206
Status:
COMPLETED
Last Update Posted:
2021-08-09
First Post:
2016-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hybrid Ablation of Persistent and Long-standing Persistent Stand-alone Atrial Fibrillation
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-02', 'studyFirstSubmitDate': '2016-06-29', 'studyFirstSubmitQcDate': '2016-07-11', 'lastUpdatePostDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'QoL measurement', 'timeFrame': '1 year', 'description': 'changes in quality of life, measured by questionnaires AFEQT'}], 'primaryOutcomes': [{'measure': 'sinus rhythm (The Reveal LINQ Insertable Cardiac Monitoring System)', 'timeFrame': '1 year', 'description': 'Number of patients with sinus rhythm, without detections of atrial arrhythmias (episodes longer than 30 seconds)'}], 'secondaryOutcomes': [{'measure': 'neurological safety (cerebral magnetic resonance (MR), neuropsychological changes - multiple questionnaires, Transcranial Doppler)', 'timeFrame': '180 days', 'description': 'new ischaemic brain lesions on MR performed at the discharge from surgery and at the 180 days visit), neuropsychological changes measured by special questionnaires, that will be filled at 30 and 180 days visit, periprocedural Doppler - hits rates on periprocedural transcranial Doppler measurement during both surgery and catheter ablation'}, {'measure': 'periprocedural complications - surgery', 'timeFrame': '30 days', 'description': 'conversion to sternotomy, bleeding, thromboembolic events, tamponade, haemothorax, pneumothorax, pleural effusion, pneumonia'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Atrial fibrillation', 'Hybrid ablation'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '29360987', 'type': 'DERIVED', 'citation': 'Osmancik P, Budera P, Zdarska J, Herman D, Petr R, Fojt R, Straka Z. Residual echocardiographic and computed tomography findings after thoracoscopic occlusion of the left atrial appendage using the AtriClip PRO device. Interact Cardiovasc Thorac Surg. 2018 Jun 1;26(6):919-925. doi: 10.1093/icvts/ivx427.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates in detail efficacy and safety (including neurological safety) of hybrid ablation of stand-alone, persistent and long-standing persistent atrial fibrillation (AF). An implantable ECG monitor will be implanted to all patients for rhythm monitoring. Neurological safety will be assessed by cerebral magnetic resonance, neuropsychological examination and periprocedural transcranial Doppler measurement.', 'detailedDescription': 'Hybrid ablation (i.e. surgical thoracoscopic ablation, followed by catheter endocardial ablation) represent a new treatment option for patients with atrial fibrillation.\n\n60 patients will undergo a two-stage, hybrid ablation, all of them will have an ECG monitoring device implanted and will be followed for up to three years. Neurological safety of both surgical and catheter procedures will be assessed by three examinations. Magnetic resonance will be performed before surgery, 5 days after surgery and at the 180 days visit to search for (subclinical) cerebral ischemia. Complex neuropsychological examination will be performed before surgery, afer 1 month after surgery and at 180 days visit to search for changes in cognitive functions, behavioral functions etc. Transcranial Doppler will be performed during surgical and catheter ablation to detect microembolic signals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with symptomatic, drug-resistant, stand-alone, persistent or long-standing persistent atrial fibrillation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients age \\> 18 years\n* Patients with persistent/long-standing persistent AF according to the standard EHRA definition.\n* Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication.\n* Absence of significant structural heart disease (dilated cardiomyopathy, hypertrophic cardiomyopathy, valvular heart disease, untreated coronary artery disease)\n* Ability to sign an informed consent\n\nExclusion Criteria:\n\n* Paroxysmal AF\n* AF secondary to a reversible cause (i.e., thyreopathy, etc.)\n* Indication for open-heart surgery (coronary artery bypass grafting, valve surgery, etc.)\n* Severe left ventricle dysfunction that is clearly caused by some other cardiac disease (dilated cardiomyopathy, ischaemic heart disease, etc.) where the AF is clearly of secondary etiology\n* Known severe pericardial and pleural adhesions (e.g., history of cardiac surgery)'}, 'identificationModule': {'nctId': 'NCT02832206', 'briefTitle': 'Hybrid Ablation of Persistent and Long-standing Persistent Stand-alone Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'EndoMaze HYBRID project-a Detailed Assessment of Efficacy and Safety of Hybrid Ablation of Persistent and Long-standing Persistent Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'PRAGUE-21'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'hybrid ablation', 'description': '60 patients with stand-alone, persistent or long-standing persistent atrial fibrillation', 'interventionNames': ['Procedure: hybrid ablation']}], 'interventions': [{'name': 'hybrid ablation', 'type': 'PROCEDURE', 'description': 'Surgical thoracoscopic epicardial ablation (box-lesion) and left atrial appendage occlusion , followed (after 2-3months) by electrophysiological examination, and catheter ablation (completion of the box-lesion, cavotricuspid isthmus ablation and other ablation if indicated)', 'armGroupLabels': ['hybrid ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10000', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Charles University, Third Faculty of Medicine', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'Zbynek Straka, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Kralovske Vinohrady'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles University, Czech Republic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., Ph.D.', 'investigatorFullName': 'Petr Budera', 'investigatorAffiliation': 'Charles University, Czech Republic'}}}}