Ignite Creation Date:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2025-12-29 @ 6:00 AM
Study NCT ID:
NCT06053606
Status:
RECRUITING
Last Update Posted:
2025-07-24
First Post:
2023-09-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Expandable Cryoballoon on Autonomic Control of the Heart
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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-20', 'studyFirstSubmitDate': '2023-09-17', 'studyFirstSubmitQcDate': '2023-09-23', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'occurence of persistent phrenic nerve palsy', 'timeFrame': 'periprocedural', 'description': 'event rate (%)'}], 'primaryOutcomes': [{'measure': 'difference in the rate of persistent parasympathetic modulation', 'timeFrame': '3 months', 'description': 'defined as decrease in RR interval of \\>20%'}], 'secondaryOutcomes': [{'measure': 'difference in time to first AF episode', 'timeFrame': '12 months', 'description': 'days'}, {'measure': 'difference in left atrial dwell time', 'timeFrame': 'periprocedural', 'description': 'minutes'}, {'measure': 'difference in radiation dose', 'timeFrame': 'periprocedural', 'description': 'mGy'}, {'measure': 'difference in contrast volume', 'timeFrame': 'periprocedural', 'description': 'mililiters'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'ganglionated plexus', 'autonomic modulation', 'cryoablation', 'cryoballoon', 'expandable balloon'], 'conditions': ['Paroxysmal Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Approximately 40% of patients following cryoballoon ablation show signs of parasympathetic denervation. The presence of such effect is related to better outcomes in terms of clinical efficacy (freedom from atrial fibrillation). It could be hypothesized that larger sized balloon (POLARxFIT system) because of more antral position within the left atrium (and hence smaller distance from ganglionated plexi) might enhance this beneficial modulation of the autonomic system of the heart. This study intends to compare the effects of cryoablation employing expandable balloon (POLARxFIT) vs. standard balloon (POLARx) on autonomic system of the heart.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary PVI\n* paroxysmal atrial fibrillation\n* sinus rhythm at the admission\n* participant meets clinical criteria for PVI\n\nExclusion Criteria:\n\n* LA diameter \\<38 mm or \\>50 mm\n* LVEF \\<40%\n* intrinsic sinus node disease\n* advanced atrioventricular block (PR interval \\>300 ms, II or III degree AV block)\n* previous cardioneuroablation procedure\n* pregnancy\n* contraindications to anticoagulation treatment\n* any other clinical contraindications to PVI\n* known atropine intolerance'}, 'identificationModule': {'nctId': 'NCT06053606', 'briefTitle': 'The Impact of Expandable Cryoballoon on Autonomic Control of the Heart', 'organization': {'class': 'OTHER', 'fullName': 'Wroclaw Medical University'}, 'officialTitle': 'The Impact of Cryoablation Using Expandable (POLARxFIT) vs. Standard Size (POLARx) Balloon on Autonomic Control of the Heart', 'orgStudyIdInfo': {'id': 'POLARxFIT and GPs'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'expandable cryoballoon', 'description': 'POLARxFIT', 'interventionNames': ['Device: cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm)']}, {'type': 'EXPERIMENTAL', 'label': 'standard cryoballoon', 'description': 'POLARx', 'interventionNames': ['Device: cryoablation of atrial fibrillation using only 28 mm size balloon']}], 'interventions': [{'name': 'cryoablation of atrial fibrillation using only 28 mm size balloon', 'type': 'DEVICE', 'description': 'all applications in all PVs are done with 28 mm balloon', 'armGroupLabels': ['standard cryoballoon']}, {'name': 'cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm)', 'type': 'DEVICE', 'description': 'first applications in LSPV and RSPV are done with 31 mm balloon', 'armGroupLabels': ['expandable cryoballoon']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50-556', 'city': 'Wroclaw', 'state': 'Lower Silesian Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Piotr Niewinski, PhD', 'role': 'CONTACT', 'email': 'pnsky@wp.pl', 'phone': '790423298'}], 'facility': 'Institute of Heart Diseases, Wroclaw Medical University', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'centralContacts': [{'name': 'Piotr Niewinski, MD, PhD', 'role': 'CONTACT', 'email': 'piotr.niewinski@umw.edu.pl', 'phone': '+48 71 733 1112'}], 'overallOfficials': [{'name': 'Piotr Niewinski, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wroclaw Medical University'}]}, 'ipdSharingStatementModule': {'timeFrame': 'after study completion', 'ipdSharing': 'YES', 'description': 'IPD that underlie results in a publication', 'accessCriteria': 'upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wroclaw Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Piotr Niewinski, MD', 'investigatorAffiliation': 'Wroclaw Medical University'}}}}