Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2025-12-25 @ 7:33 PM
Study NCT ID:
NCT05063032
Status:
RECRUITING
Last Update Posted:
2024-01-10
First Post:
2021-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Left Atrial FLUTter: a Comparison of Ablation Guided by High-density MApping and Empirical LINEar Ablation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1 parallell, randomized, controlled, open-label, single center clinical trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-08', 'studyFirstSubmitDate': '2021-09-07', 'studyFirstSubmitQcDate': '2021-09-22', 'lastUpdatePostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients without sustained (≥30 s) atrial arrhythmia episodes over 1-year follow-up in each group.', 'timeFrame': '1 year follow-up', 'description': 'Daily 1-lead 30 seconds ECG samples.'}], 'secondaryOutcomes': [{'measure': 'Acute success.', 'timeFrame': 'Acute intraprocedural.', 'description': 'Termination of all organized atrial arrhythmias (spontaneous or induced, organized and stable atrial arrhythmias with duration ≥3 min).'}, {'measure': 'Non-inducibility.', 'timeFrame': 'Acute intraprocedural.', 'description': 'Non-inducibility of all organized atrial arrhythmias at the end of the ablation procedure.'}, {'measure': 'Procedure duration.', 'timeFrame': 'Acute intraprocedural.', 'description': 'From vein puncture up to seaths withdrawal.'}, {'measure': 'Left atrial dwell time.', 'timeFrame': 'Acute intraprocedural.', 'description': 'From transeptal puncture up to catheters withdrawal from the left atrium.'}, {'measure': 'Safety.', 'timeFrame': 'Acute a 1 month after ablation (procedure-related complications).', 'description': 'Incidence of compications: 1)vascular lesions, 2)cardiac tamponade, 3)embolism.'}, {'measure': 'Hospitalization.', 'timeFrame': '1 year.', 'description': 'Number of hospitalizations due to atrial arrhythmia episodes at 1-year follow-up.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Left atrial flutter', 'Linear ablation', 'High-density mapping'], 'conditions': ['Arrhythmias, Cardiac']}, 'descriptionModule': {'briefSummary': 'Unicenter, 1:1 randomized, open-labelled clinical trial comparing left atrial flutter ablation using high density mapping or strict lineal ablation. Main outcome: arrhythmia recurrences over 1 year follow-up with daily 1-lead 30 seconds ECG samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Left atrial flutter1 inducible during electrophysiological evaluation.\n* Clinical indication for ablation: a) symptoms (palpitations, dizziness, syncope, breathlessness, derangement, heart failure), tachymiopathy, b) poor heart rate control, or c) recurrence after electrical cardioversion or failure of one antiarrhythmic drug.\n* Informed consent.\n\n 1. Patients will be enrolled if LAFL is clinically suspected but finally randomized if this mechanism is established by electrophysiologic evaluation according to the criteria stated above.\n\nExclusion criteria\n\n* Previous ablation of LAFL.\n* Previous linear ablation in the LA except for pulmonary vein isolation.\n* Absolute contraindication for oral anticoagulation.\n* Stroke or acute coronary syndrome less than 3 months before ablation.\n* Complex congenital heart disease.'}, 'identificationModule': {'nctId': 'NCT05063032', 'acronym': 'FLUTMALINE', 'briefTitle': 'Left Atrial FLUTter: a Comparison of Ablation Guided by High-density MApping and Empirical LINEar Ablation.', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario La Paz'}, 'officialTitle': 'Left Atrial FLUTter: a Comparison of Ablation Guided by High-density MApping and Empirical LINEar Ablation - the FLUTMALINE Trial', 'orgStudyIdInfo': {'id': '5825 v 3.0, 3030th March 2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-density mapping guided ablation', 'description': 'High-density map and return-cycles map in order to localize the protected isthmus with precision for focal/minimal ablation.', 'interventionNames': ['Other: Radiofrecuency ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Empirical linear ablation', 'description': 'Empirical predefined set of linear ablation.', 'interventionNames': ['Other: Radiofrecuency ablation']}], 'interventions': [{'name': 'Radiofrecuency ablation', 'type': 'OTHER', 'description': 'Radiofrequency ablation to treat left atrial flutter, guided by high-density mapping versus linear ablation.', 'armGroupLabels': ['Empirical linear ablation', 'High-density mapping guided ablation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'José Luis Merino, MD', 'role': 'CONTACT', 'email': 'lapaz@arritmias.net', 'phone': '+34 912071301'}], 'facility': 'La Paz University Hospital, Department of Cardiology', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Sergio C Castrejón, PhD', 'role': 'CONTACT', 'email': 'lapaz@arritmias.net', 'phone': '+34 659048245'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario La Paz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Electrophysiologist, Principal investigator (togheter with Dr. José Luis Merino)', 'investigatorFullName': 'Dr. Sergio Castrejón-Castrejón', 'investigatorAffiliation': 'Hospital Universitario La Paz'}}}}