Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-26 @ 4:03 PM
Study NCT ID:
NCT06291506
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2024-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SUbstrate Ablation in Persistent Atrial Fibrillation for Elimination of Recurrences (SUPAFER).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1 randomization'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 176}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2024-01-08', 'studyFirstSubmitQcDate': '2024-02-26', 'lastUpdatePostDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrences of sustained >30 secons atrial arrhythmias measured by daily ECG samples (Kardia Alivecor) and 30 days continuous Holter.', 'timeFrame': 'through study completion, 1 year follow-up', 'description': 'Atrial fibrillation, atrial tachycardia (atrial flutter).'}], 'secondaryOutcomes': [{'measure': 'Acute intraprocedure efficacy.', 'timeFrame': 'during the ablation procedure and up to 2 months blanking perior', 'description': 'Rate of: AF termination to sinus rhythm, organization to atrial tachycardia and non inducibility of AF or atrial tachycardia.'}, {'measure': 'Complications.', 'timeFrame': 'through study completion, 1year follow-up', 'description': 'Complications associated to the ablation procedure.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Persistent and Long Lasting or Chronic Atrial Fibrillation', 'Atrial Fibrillation Ablation', 'Linear Left Atrial Ablation', 'Daily Transtelephonic Electrocardiogram']}, 'descriptionModule': {'briefSummary': 'Antecedents: electrical isolation of pulmonary veins is the standard treatment for patients with atrial fibrillation. However, its efficacy is lower in persistent and chronic forms of this arrhythmia compared to paroxysmal atrial fibrillation. Many complementary techniques have been proposed, that added to pulmonary veins isolation, may reduce the recurrence rate of atrial fibrillation. However, none of them has obtained consistent results. Linear ablation aims to parcellate and modify the left atrial substrate responsible for atrial fibrillation maintenance. Previous studies have offered contradictory results using linear ablation.\n\nMethods: SUPAFER is a multicenter, 1:1 randomized clinical trial that compares the efficacy of pulmonary veins isolation alone vs pulmonary vein isolation plus an specific protocol of left atrial linear ablation. Contrary to previous studies, the specific SUPAFER linear ablation is systematic, homogeneous and target atrial areas that have not been systematically ablated in previous trials. The trial aims at demonstrating the superiority of the combined ablative approach during 1-year follow-up. Daily transtelephonic ECG samples a 30 days continuous ECG monitoring are used to maximize de detection of recurrences, even asymptomatic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persistent atrial fibrillation documented with electrocardiogram and defined as: persistent (continuous AF duration \\>1 week) or long-lasting persistent (continuous AF duración \\>1 year).\n* One of the following additional criteria: 1)symptomatic AF, 2)recurrence despite antiarrhythmic drugs or after electrical cardioversion, 3)tachymiopathy, 4)heart failure, 5)antiarrhythmic drugs either not tolerated or rejected or considered inadequate by the patient or an electrophysiology specialist, 6)preference for ablation explicitly manifested by the patient.\n* Age \\>=18 years and written informed consent.\n\nExclusion Criteria:\n\n* AF with a reversible cause.\n* Previous pulmonary veins isolation or left atrial linear ablation.\n* Cardiac surgery, acute coronary syndrome, percutaneous coronary intervention o ischaemic stroke \\<1 month before ablation.\n* Intracranial haemorrhage \\<3 months before ablation.\n* Ablation contraindicated due to 1)absolute contraindication for oral anticoagulants, 2)persistent atrial thrombus, 3)pregnancy, 4)extreme fragility and 5)life expectancy \\<1 year.'}, 'identificationModule': {'nctId': 'NCT06291506', 'acronym': 'SUPAFER', 'briefTitle': 'SUbstrate Ablation in Persistent Atrial Fibrillation for Elimination of Recurrences (SUPAFER).', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario La Paz'}, 'officialTitle': ': SUbstrate Ablation in Persistent Atrial Fibrillation for Elimination of Recurrences (SUPAFER): a Multicentre Randomized Clinical Trial to Assess Pulmonary Vein Isolation Alone or Combined With Linear Ablation.', 'orgStudyIdInfo': {'id': '6270'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pulmonary veins isolation plus linear left atrial ablation.', 'interventionNames': ['Other: Radiofrequency ablation of heart atrial tissue.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pumonary veins isolation only.', 'interventionNames': ['Other: Radiofrequency ablation of heart atrial tissue.']}], 'interventions': [{'name': 'Radiofrequency ablation of heart atrial tissue.', 'type': 'OTHER', 'description': 'Ablation with radiofrequency, advances techniques: contact force-guided, improved tissue temperature sensors, automark algorithms.', 'armGroupLabels': ['Pulmonary veins isolation plus linear left atrial ablation.', 'Pumonary veins isolation only.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'José Luis Merino, MD', 'role': 'CONTACT', 'email': 'lapaz@arritmias.net', 'phone': '+34 912071301'}, {'name': 'Sergio Castrejón Castrejón', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'La Paz University Hospital - IdiPaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'José Luis Merino Llorens, MD, PhD', 'role': 'CONTACT', 'email': 'lapaz@arritmias.net', 'phone': '+34 912071301', 'phoneExt': '441301'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario La Paz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant of Cardiology, main coinvestigator, coordinator.', 'investigatorFullName': 'Dr. Sergio Castrejón-Castrejón', 'investigatorAffiliation': 'Hospital Universitario La Paz'}}}}