Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-05 @ 4:06 AM
Study NCT ID:
NCT05777850
Status:
UNKNOWN
Last Update Posted:
2023-03-21
First Post:
2023-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-Power Short-Duration Radiofrequency Ablation in Patients With Typical Atrial Flutter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-09', 'studyFirstSubmitDate': '2023-03-09', 'studyFirstSubmitQcDate': '2023-03-09', 'lastUpdatePostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety primary outcome: incidence of procedure-related complications.', 'timeFrame': 'One year', 'description': 'Number of procedure-related complications from the time of the ablation until the last follow-up visit.'}, {'measure': 'Efficacy primary outcome: typical atrial flutter recurrence.', 'timeFrame': 'One year', 'description': "Incidence of typical atrial flutter recurrence during a one-year follow-up period. To be considered clinically relevant the recurrence must be documented by a full EKG made because of patients' symptoms or any typical atrial flutter detected by an EKG, 24h Holter-EKG or events-monitoring device that will be performed at least at a 6 months and 12 months follow-up visits."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Typical Atrial Flutter Cavotricuspid Isthmus', 'Cavotricuspid Isthmus', 'High-Power Short-Duration'], 'conditions': ['Typical Atrial Flutter', 'Catheter Ablation']}, 'referencesModule': {'references': [{'pmid': '39708245', 'type': 'DERIVED', 'citation': 'Valverde Soria L, Toquero J, Brouzet T, Garcia Cano L, Garcia Barrios A, Segura Dominguez M, Hermon Ramirez GA, Ajo Ferrer R, Ajo Ferrer M, Andreu Concha CM, Arrarte Esteban V, Sanchez Barbie A, Martinez-Martinez JG, Ibanez Criado A, Ibanez Criado JL. Very high-power short-duration radiofrequency ablation in patients with typical atrial flutter: rationale and design of the FASD-HP randomized trial. J Interv Card Electrophysiol. 2025 Apr;68(3):497-503. doi: 10.1007/s10840-024-01969-7. Epub 2024 Dec 21.'}]}, 'descriptionModule': {'briefSummary': "The aim of cavotricuspid isthmus (CTI) dependent flutter ablation is the bidirectional conduction block of CTI. The probability of achieving a permanent bidirectional block at the CTI depends, mainly, on the ablation energy applied and the quality of the obtained lesion. Among the factors that determine the lesion's quality those which have the bigger impact are catheter stability, contact force, power and duration of energy application and the temperature reached at depth.This is a multicenter 1:1 randomized, blinded (open for the operator) study. Two CTI ablation strategies are compared: 1) conventional treatment branch which consists of individual 25-40 W applications of unlimited duration until achieving in each application the minimum value of one of the currently accepted and used lesion markers (Ablation Index \\>500 at the anterior half of the CTI and \\>400 at the posterior half with de CARTO 3 system; 2) experimental treatment branch consistent of CTI block using individual high power (90W) short duration (4 seconds) point-by-point applications. The main objective of this study is assessing the non-inferiority of the efficacy and safety of high-power short-duration ablation in patients undergoing typical atrial flutter ablation. Secondary objectives include the comparison of total radiofrequency time, number of applications, number of steam pops, percentage of reconnections, procedure duration, pain during the procedure and time to atrial flutter recurrence."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with cavotricuspid isthmus dependent flutter referred to ablation\n* Patients clinically and hemodynamically stable.\n* Patients who give informed consent.\n\nExclusion Criteria:\n\n* Refusal to participate in the register or inability to understand the informed consent.\n* Age under 18.\n* Patients who have already undergone previous flutter ablation procedures.'}, 'identificationModule': {'nctId': 'NCT05777850', 'acronym': 'FASD-HP', 'briefTitle': 'High-Power Short-Duration Radiofrequency Ablation in Patients With Typical Atrial Flutter', 'organization': {'class': 'OTHER', 'fullName': 'Hospital General Universitario de Alicante'}, 'officialTitle': 'High-Power Short-Duration Radiofrequency Ablation in Patients With Typical Atrial Flutter', 'orgStudyIdInfo': {'id': 'FASD-HP trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional ablation', 'description': 'CTI ablation with electroanatomic navigation system using individual 25-40 W applications of unlimited duration until achieving in each application the minimum value of one of the currently accepted and used lesion markers: Ablation Index \\>500 at the anterior half of the CTI and \\>400 at the posterior half with de CARTO 3 system. Minimum contact force required is 5 grams. Maximum distance between applications must be 6 mm.', 'interventionNames': ['Procedure: Conventional cavotricuspid isthmus ablation']}, {'type': 'EXPERIMENTAL', 'label': 'High-power short-duration ablation', 'description': "CTI ablation with electroanatomic navigation system using individual high power (90W) short duration (4 seconds) applications in a catheters' stable position with a minimum contact force of 15-30 g at the anterior half and 10-25 g at the posterior one. Maximum distance between applications is settled at 4 mm.", 'interventionNames': ['Procedure: High-power short-duration ablation']}], 'interventions': [{'name': 'Conventional cavotricuspid isthmus ablation', 'type': 'PROCEDURE', 'description': 'Point-by-point 25-40 W applications at the CTI of unlimited duration until achieving the pre-established Ablation Index.', 'armGroupLabels': ['Conventional ablation']}, {'name': 'High-power short-duration ablation', 'type': 'PROCEDURE', 'description': 'Point-by-point 90W applications at the CTI ablation during 4 seconds.', 'armGroupLabels': ['High-power short-duration ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03010', 'city': 'Alicante', 'state': 'A', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Laura Valverde Soria', 'role': 'CONTACT', 'email': 'lauravalverdesoria@gmail.com', 'phone': '+34687198597'}, {'role': 'CONTACT', 'email': 'lauravalverdesoria@gmail.com', 'phoneExt': 'Valverde Soria'}, {'name': 'Laura Valverde Soria, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alicia Ibáñez Criado, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Thomas Brouzet, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Amaya García Fernández, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Laura García Cano, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marta Herrero Brocal, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ana García Barrios, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jose Luis Ibáñez Criado, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Raquel Ajo Ferrer, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'María Ajo Ferrer', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ángela Carrillo Molina', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital General Doctor Balmis Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}], 'centralContacts': [{'name': 'Laura Valverde Soria', 'role': 'CONTACT', 'email': 'lauravalverdesoria@gmail.com', 'phone': '687198597'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jose Luis Ibañez Criado', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Jose Luis Ibañez Criado', 'investigatorAffiliation': 'Hospital General Universitario de Alicante'}}}}