Ignite Creation Date:
2025-12-24 @ 1:56 PM
Ignite Modification Date:
2025-12-25 @ 3:44 PM
Study NCT ID:
NCT05709795
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2022-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CTI Ablation Guided by Omnipolar Wave Speed and Voltage Maps to Diminish RF and Fluoroscopy Times
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': ['PARTICIPANT'], 'maskingDescription': 'Patient won´t know what strategy has been followed to achieve CTI block'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective randomized multicentric'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-02', 'studyFirstSubmitDate': '2022-11-04', 'studyFirstSubmitQcDate': '2023-01-24', 'lastUpdatePostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiofrequency time', 'timeFrame': '24 hours', 'description': 'Amount of Radiofrequency needed to achieve complete CTI block (acute success)'}, {'measure': 'Fluoroscopy time', 'timeFrame': '24 hours', 'description': 'Amount of Fluroscopy time needed to achieve complete CTI block (acute success)'}, {'measure': 'Radiation dose', 'timeFrame': '24 hours', 'description': 'Amount of Radiation dose needed to achieve complete CTI block (acute success)'}, {'measure': 'Zero Fluoroscopy', 'timeFrame': '24 hours', 'description': 'Percentage of patients performed without the use of fluoroscopy'}, {'measure': 'Acute efficay', 'timeFrame': '24 hours', 'description': 'Percentage of acute succeess (complete block of the CTI)'}, {'measure': 'Complications', 'timeFrame': '2 months', 'description': 'Percentage of procedural complications'}], 'secondaryOutcomes': [{'measure': 'Flutter recurrences', 'timeFrame': '6 months', 'description': 'Percentage of recurrences of typical flutter at 6 months follow up'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Flutter']}, 'descriptionModule': {'briefSummary': 'Prospective randomized study involving patients with typical flutter (TF) undergoing cavo-tricuspid isthmus (CTI) radiofrequency ablation. The aim is to compare the results of 3 different new ablation strategies using Omnipolar technology to classic linear ablation.\n\nThe investigators´ aim is to compare the effectiveness, safety and procedure times of CTI ablation with 3 different strategies using the Ensite X navigator in magnetic mode with Omnipolar technology and HDGrid catheter to optimize radiofrequency (RF) and fluoroscopy times with classical linear ablation.\n\nThe number of patients needed to prove the investigators´ hypothesis is of at least 50 per group (total of 200 prospective patients', 'detailedDescription': 'Background Ablation procedures for CTI-dependent TF have classically been guided by fluoroscopy and intracavitary electrograms from diagnostic catheters placed in the right atrium (RA), the coronary sinus (CS) and the CTI (ablation catheter). Over the last few years, the use of navigators has increased considerably not only for complex procedures, but also for simple procedures, with the aim of reducing and even completely eliminating irradiation to both the patient and the operator (1). The investigators´ group is looking to characterize the high voltage and the low velocity regions in the CTI to minimize the procedure times. This has been addressed in a recent observational study with very good results.\n\nRationale There is increasing evidence of the benefits using 3D-systems not only to diminish fluoroscopy, but also to guide ablation targeting high voltage areas in the CTI (2-5). It is well known also the existence of low speed areas in the CTI, facilitating the presence of reentrant circuits (6,7). Currently, the investigators´ center performs all CTI ablation procedures using a 3D-navigator system, mostly with zero or minimal fluoroscopy. The investigators´ group has carried out a preliminary study with 13 patients to assess the effectiveness of CTI ablation with the use of the Ensite X navigator in magnetic mode with Omnipolar technology and HDGrid catheter. In this observational study the investigators were able to characterize the high voltage and the low velocity regions in the CTI to minimize the RF lesions and procedure times. Acute bidirectional block was achieved in 100% of patients with an average fluoroscopy time of 1 ± 2 min (77% patients with zero fluoroscopy) and an average RF time of 5,7 ± 3,2 min (38% below 3 min). This results were significantly lower than results obtained with classical linear ablation: median fluoroscopy time 19.3 min, IQR 12.9 to 36.4 min, median fluoroscopy dose 3520.7 cGycm(2), IQR 1700.0 to 6709.0 cGycm(2).\n\nFrom the investigators´ point of view this observational study, together with previous evidence justify a randomized study in order to confirm our hypothesis:\n\nHypothesis Omnipolar technology is able to guide the ablation procedure minimizing both the RF time and the fluoroscopy time (compared to linear ablation) by targeting only the critical regions on the CTI. Therefore Omnipolar technology will diminish RF time and fluoroscopy time/exposition compared to classical CTI ablation, and by means of this the investigators expect an inferior complications rate. Importantly acute success rate and 6 months follow-up recurrences rate will remain similar.\n\nOBJECTIVES\n\n* Primary objectives: to optimize procedure times of CTI ablation with 3 different strategies based in voltage and/or conduction velocity maps using the Ensite X navigator in magnetic mode with Omnipolar technology and HDGrid catheter compared to classical linear ablation.\n\n o Specific objectives: Fluoroscopy time, radiofrequency time, radiation dose, percentage of zero-fluoroscopy procedures, acute efficacy, complications rate.\n* Secondary objectives: to increase the effectiveness of CTI ablation with 3 different strategies based in voltage and/or conduction velocity maps using the Ensite X navigator in magnetic mode with Omnipolar technology and HDGrid catheter compared to classical linear ablation.\n\n * Specific objectives: Recurrences rate at 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients submitted to CTI ablation for TF\n* Age above 18 years\n\nExclusion Criteria:\n\n• Life expectancy of \\<1 year'}, 'identificationModule': {'nctId': 'NCT05709795', 'briefTitle': 'CTI Ablation Guided by Omnipolar Wave Speed and Voltage Maps to Diminish RF and Fluoroscopy Times', 'organization': {'class': 'OTHER', 'fullName': 'Parc de Salut Mar'}, 'officialTitle': 'CTI Ablation Guided by Omnipolar Wave Speed and Voltage Maps to Diminish RF and Fluoroscopy Times', 'orgStudyIdInfo': {'id': 'OMNIFLUTTER'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Confluent areas', 'description': 'Ablation first of confluent areas of low wave speed and high voltage in the CTI', 'interventionNames': ['Procedure: Confluent areas']}, {'type': 'EXPERIMENTAL', 'label': 'Wave Speed', 'description': 'Ablation first of areas of low wave speed in the CTI', 'interventionNames': ['Procedure: Wave Speed']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Voltage', 'description': 'Ablation first of areas of high voltage in the CTI', 'interventionNames': ['Procedure: Voltage']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CTI line', 'description': 'Direct CTI line performance (gold standard)', 'interventionNames': ['Procedure: CTI line']}], 'interventions': [{'name': 'Confluent areas', 'type': 'PROCEDURE', 'otherNames': ['Omnipolar', 'HD Grid catheter'], 'description': 'Use of omnipolar technology to guide CTI ablation in sites with both low wave speed and high voltage. If not successful then ablation of low wave speed sites. If not successful then ablation of high voltage sites. If not successful then CTI line (gold standard)', 'armGroupLabels': ['Confluent areas']}, {'name': 'Wave Speed', 'type': 'PROCEDURE', 'description': 'Use of omnipolar technology to guide CTI ablation in sites with low wave speed. If not successful then ablation of sites with both low wave speed and high voltage. If not successful then ablation of high voltage sites. If not successful then CTI line (gold standard)', 'armGroupLabels': ['Wave Speed']}, {'name': 'Voltage', 'type': 'PROCEDURE', 'description': 'Use of omnipolar technology to guide CTI ablation in sites with high voltage. If not successful then ablation of sites with both low wave speed and high voltage. If not successful then ablation of low wave speed sites. If not successful then CTI line (gold standard)', 'armGroupLabels': ['Voltage']}, {'name': 'CTI line', 'type': 'PROCEDURE', 'description': 'Do not use omnipolar information. CTI line performance', 'armGroupLabels': ['CTI line']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Victor Bazan', 'role': 'CONTACT'}], 'facility': 'Hospital Germans Tries', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08003', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ermengol Vallès, PhD.', 'role': 'CONTACT', 'email': 'evalles@psmar.cat', 'phone': '+34932483456', 'phoneExt': '3456'}, {'name': 'Carlos González, M.D.', 'role': 'CONTACT', 'email': 'cgonzalezmatos@psmar.cat', 'phone': '+34932483456', 'phoneExt': '3456'}, {'name': 'Ermengol Vallès, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Carlos González, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Ermengol Valles, PhD', 'role': 'CONTACT', 'email': 'evalles@psmar.cat', 'phone': '0034932483118'}], 'overallOfficials': [{'name': 'Ermengol Valles', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital del Mar'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Available by the study initiation, on March 2023, and until the publication', 'ipdSharing': 'YES', 'description': 'RedCap database and randomization tool'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Parc de Salut Mar', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Ermengol Vallès', 'investigatorAffiliation': 'Parc de Salut Mar'}}}}