Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2025-12-31 @ 7:20 PM
Study NCT ID:
NCT03854006
Status:
UNKNOWN
Last Update Posted:
2019-11-14
First Post:
2019-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cryoballoon Pulmonary Vein Isolation: Time-to-Isolation Dependent Freeze Protocols Comparison
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The investigators will examine long-term efficacy of Cryo-AF using the two proposed dosing algorithms in a nonrandomized fashion.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-13', 'studyFirstSubmitDate': '2019-02-16', 'studyFirstSubmitQcDate': '2019-02-23', 'lastUpdatePostDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Atrial Fibrillation Recurrence', 'timeFrame': '3 months after the procedure'}, {'measure': 'Atrial Fibrillation Recurrence', 'timeFrame': '12 months after the procedure'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atrial Fibrillation'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop and prospectively test two Cryo-AF (atrial fibrillation) dosing protocols guided exclusively by time-to-isolation (TT-I) in patients undergoing a first-time Cryo-AF.\n\nBoth protocols guided by TT-I are associated with shorter cryoapplications as compared to conventional approach.\n\nIn the first group freeze duration is TTI +120 s. In the second group freeze duration is 240s if TTI is \\< 75 s. In case of TTI\\>75s a 240s bonus freeze is applied.\n\nThe investigators examine long-term efficacy of Cryo-AF using the two proposed dosing algorithms in a nonrandomized fashion.\n\nThe study cohort consists of consecutive patients undergoing a first-time Cryo-AF for symptomatic paroxysmal or persistent AF (atrial fibrillation) at Interventional Cadiology and Cardiac Arrhythmias Clinic of Medical University in Łódź. During 12 months investigators are planning to enroll 40 patients Patients are randomly assigned to the groups. All of them will be followed up 3 and 12 months after the procedure. In addition, ambulatory electrocardiographic monitoring will also be performed at 3 and 12 months.\n\nThe study is requested for an approval of the university ethics committee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDiagnosis of Paroxysmal or Persistent Atrial Fibrillation on Electrocardiogram\n\nExclusion Criteria:\n\nDiagnosis of Sinus Rhythm on Electrocardiogram'}, 'identificationModule': {'nctId': 'NCT03854006', 'briefTitle': 'Cryoballoon Pulmonary Vein Isolation: Time-to-Isolation Dependent Freeze Protocols Comparison', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Lodz'}, 'officialTitle': 'Cryoballoon Pulmonary Vein Isolation: Time-to-Isolation Dependent Freeze Protocols Comparison', 'orgStudyIdInfo': {'id': '22012019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Freeze cycle: 240 s - TTI <75 s or 2x240 s - >75 s', 'description': 'In the first group freeze duration is 240s if TTI (time-to-isolation) is \\< 75 s. In case of TTI\\>75s a 240s bonus freeze is applied.\n\nIf no TTI could be documented, a single 240 s freeze cycle is applied in this group in case of balloon temperature -40°C (degrees Celsius) after 60 s.', 'interventionNames': ['Procedure: Cryoballoon pulmonary vein isolation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Freeze cycle: TTI+120 s', 'description': 'In the second group freeze duration is TTI (time-to-isolation) +120 s. If no TTI could be documented, a single 180 s freeze cycle is applied in this group in case of balloon temperature -40 °C after 60 s.', 'interventionNames': ['Procedure: Cryoballoon pulmonary vein isolation']}], 'interventions': [{'name': 'Cryoballoon pulmonary vein isolation', 'type': 'PROCEDURE', 'description': 'During cryoballoon pulmonary vein isolation, under local anaesthesia, diagnostic catheters are placed in the coronary sinus. The cryoballoon is advanced to the left atrium via a steerable sheath after single transseptal puncture and inflated at the PV(pulmonary vein) ostia. A spiral mapping catheter is advanced through the balloon inner lumen and positioned in the PV at the closest achievable proximity to the cryoballoon in order to record real-time PV potentials during PV isolation. During PV isolation the potentials from the PV are recorded. The TTI is defined as the time of the last recording of a PV potential before sustained isolation. Isolation of all PVs is reassessed at the end of the procedure by documentation of entrance- and exit-block.', 'armGroupLabels': ['Freeze cycle: 240 s - TTI <75 s or 2x240 s - >75 s', 'Freeze cycle: TTI+120 s']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90-549', 'city': 'Lodz', 'state': 'Łódź Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Izabela Warchoł', 'role': 'CONTACT', 'email': 'izabelaritawarchol@gmail.com', 'phone': '794982391', 'phoneExt': '+48'}], 'facility': 'Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej - Centralny Szpital Weteranów', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}], 'centralContacts': [{'name': 'Izabela Warchoł', 'role': 'CONTACT', 'email': 'izabelaritawarchol@gmail.com', 'phone': '794982391', 'phoneExt': '+48'}, {'name': 'Tomasz Kucejko', 'role': 'CONTACT', 'email': 'tomaszkucejko@gmail.com'}], 'overallOfficials': [{'name': 'Andrzej Lubinski, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical University of Lodz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Lodz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Izabela Warchol', 'investigatorAffiliation': 'Medical University of Lodz'}}}}