Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2025-12-26 @ 1:28 PM
Study NCT ID:
NCT04337567
Status:
UNKNOWN
Last Update Posted:
2020-04-07
First Post:
2020-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiofrequency Ablation Versus Balloon Cryoablation in Elderly Patients With 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}], 'ancestors': [{'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-03', 'studyFirstSubmitDate': '2020-03-08', 'studyFirstSubmitQcDate': '2020-04-03', 'lastUpdatePostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'atrial arrhythmia recurrence', 'timeFrame': '1 year', 'description': 'Number of Participants with recurrence of any atrial arrhythmia with a duration of 30 sec or longer 12 months after the ablative treatment'}], 'secondaryOutcomes': [{'measure': 'procedural duration', 'timeFrame': 'periprocedural', 'description': 'Duration of the whole procedure \\[min\\] inclusive preparation (from entrance to the EP lab till exit from the EP lab)'}, {'measure': 'time to wake-up after propofol withdrawal', 'timeFrame': 'periprocedural', 'description': 'Time from withdrawal of propofole till patient awake and fully oriented (time, place, person)'}, {'measure': 'contrast medium dosis', 'timeFrame': 'periprocedural', 'description': 'Amount of contrast medium used'}, {'measure': 'Propofoldosis', 'timeFrame': 'periprocedural', 'description': 'Propofoldosis needed for sedation'}, {'measure': 'groin complications', 'timeFrame': 'up to 3 months after dismission from the hospital', 'description': 'Number of Participants in each randomisation arm with groin complications (hematoma, av fistel, Aneuryma spurium, infection).'}, {'measure': 'Neurological complications', 'timeFrame': '1 year', 'description': 'Number of Participants in each randomisation arm with transient ischemic attack, cerebral insult, cerebral haemorrhage'}, {'measure': 'vascular complications', 'timeFrame': '1 year', 'description': 'Number of Participants in each randomisation arm with deep vein thrombosis, peripheral embolism.'}, {'measure': 'duration of hospital staying [days]', 'timeFrame': '1 year', 'description': 'duration of hospital staying: from admission till discharge in days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ablative treatment of atrial fibrillation', 'ballon cryoablation', 'radiofrequency ablation', 'elderly patients'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This study compares the procedural characteristics and effectivity of radiofrequency ablation and cryoablation in patients with atrial fibrillation that are 75 years or older.', 'detailedDescription': 'Radiofrequency and cryoballon ablation have been shown to be comparable to each other in terms of safety and effectivity in patients with atrial fibrillation. However, elderly patients have been underrepresented in the previous studies. The number of older patients with atrial fibrillation is high and the number of who undergo an ablation procedure for atrial fibrillation increases steadily. This prospective randomized trial compares the effectivity (recurrency of atrial arrhythmias) and periprocedural characteristics of the two established ablation methods in patients who are 75 years or older.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with recurrent symptomatic paroxysmal or persistent atrial fibrillation\n* At the day of their inclusion in the study the patients have to have completed the 75th year of life\n\nExclusion Criteria:\n\n* Dementia\n* Presence of left atrial thrombus\n* Left atrial volume\\> 50 ml/m²\n* Renal failure (GFR≤ 30 ml/min)\n* Comorbidity with an expected survival of 12 months or less.'}, 'identificationModule': {'nctId': 'NCT04337567', 'briefTitle': 'Radiofrequency Ablation Versus Balloon Cryoablation in Elderly Patients With Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Vivantes Netzwerk für Gesundheit GmbH'}, 'officialTitle': 'A Prospective Randomized Trial for the Comparison of Procedural Characteristics and Long-term Effects of Radiofrequency Ablation and Balloon Cryoablation in Elderly Patients With Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'RS_RFCR_ELDPA_0120'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Patients over 75 years_RF ablation', 'description': 'Patients randomized to receive pulmonary vein isolation by means of radiofrequency ablation.', 'interventionNames': ['Procedure: radiofrequency ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patients over 75 years_ballon cryoablation', 'description': 'Patients randomized to receive pulmonary vein isolation by means of ballon cryoablation.', 'interventionNames': ['Procedure: ballon cryoablation']}], 'interventions': [{'name': 'radiofrequency ablation', 'type': 'PROCEDURE', 'description': 'ablative treatment as allocated to radiofrequency ablation', 'armGroupLabels': ['Patients over 75 years_RF ablation']}, {'name': 'ballon cryoablation', 'type': 'PROCEDURE', 'description': 'ablative treatment as allocated to ballon cryoablation', 'armGroupLabels': ['Patients over 75 years_ballon cryoablation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Charalampos Kriatselis, MD', 'role': 'CONTACT', 'email': 'charalampos.kriatselis@vivantes.de', 'phone': '0049 30 15140663741'}, {'name': 'Michael Distler, MD', 'role': 'CONTACT', 'email': 'michael.distler@vivantes.de', 'phone': '0049 30 130 142014'}], 'facility': 'Vivantes Klinikum Neukölln', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Charalampos Kriatselis, MD', 'role': 'CONTACT', 'email': 'charalampos.kriatselis@vivantes.de', 'phone': '0049 30 15140663741'}, {'name': 'Michael Distler, MD', 'role': 'CONTACT', 'email': 'michael.distler@vivantes.de', 'phone': '0049 30 130 142014'}], 'overallOfficials': [{'name': 'Charalampos Kriatselis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vivantes Clinic Neukölln'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vivantes Netzwerk für Gesundheit GmbH', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Charalampos Kriatselis', 'investigatorAffiliation': 'Vivantes Netzwerk für Gesundheit GmbH'}}}}