Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2026-02-27 @ 10:34 AM
Study NCT ID:
NCT03148392
Status:
UNKNOWN
Last Update Posted:
2019-08-28
First Post:
2017-04-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assess Differences in Pain Following Cryo and Radiofrequency Atrial Fibrillation Ablation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-01-28', 'releaseDate': '2021-11-22'}, {'resetDate': '2022-05-27', 'releaseDate': '2022-03-07'}, {'resetDate': '2023-12-13', 'releaseDate': '2023-03-16'}, {'resetDate': '2024-05-30', 'releaseDate': '2023-12-18'}], 'estimatedResultsFirstSubmitDate': '2021-11-22'}}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-22', 'studyFirstSubmitDate': '2017-04-27', 'studyFirstSubmitQcDate': '2017-05-08', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity Measurement', 'timeFrame': '7 Days', 'description': 'Self report pain intensity measured at baseline and then once a day beginning at least four hours after the ablation. Three individual pain scales will be used. Universal Pain Assessment Tool is scored 0 to 10 with 0 = no pain and 10 = severe.'}], 'secondaryOutcomes': [{'measure': 'Health Status and Activity Measurement', 'timeFrame': '7 Days', 'description': 'Self report health status and activity measured at baseline and then once a day beginning at least four hours after the ablation using SF-36 Health and Well-Being Questionnaire.'}, {'measure': 'Pain Medication Assessment', 'timeFrame': '30 Days', 'description': 'Assess amount and duration of pain medication required post ablation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The primary objective is to assess any differences in patient quality of life between Cryo Balloon ablation and Radiofrequency ablation in the treatment of atrial fibrillation. The study will also assess any differences in the amount and duration of pain medication required after the ablation.', 'detailedDescription': 'Currently there are several different accepted techniques for performing ablation of atrial fibrillation. The two primary techniques currently in use in our center for atrial fibrillation are Cryo Balloon and Radiofrequency ablation.\n\nBased on personal observation, it is felt that patients undergoing Radiofrequency ablation have a higher incidence of chest discomfort and subsequently a greater requirement for pain medications post procedure as compared to those patients undergoing Cryo ablation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cardiology', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Paroxysmal atrial fibrillation who are advised either Cryoablation or Radiofrequency ablation for treatment.\n\nExclusion Criteria:\n\n* Persistent atrial fibrillation\n* Pregnant\n* Taking pain medications for acute or chronic conditions at the time of the procedure.\n* Undergo a combination of Cryoablation and Radiofrequency ablation\n* Radiofrequency group who undergo ablation beyond pulmonary vein isolation'}, 'identificationModule': {'nctId': 'NCT03148392', 'briefTitle': 'Assess Differences in Pain Following Cryo and Radiofrequency Atrial Fibrillation Ablation', 'organization': {'class': 'OTHER', 'fullName': 'Langhorne Cardiology Consultants, Inc.'}, 'officialTitle': 'A Prospective Comparison of Quality of Life Following Atrial Fibrillation Ablation Using the Arctic Front Advance Cryo Balloon Compared to Contact Force Sensing Radiofrequency Catheter Ablation', 'orgStudyIdInfo': {'id': 'Cryo RF Ablation QOL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cryo Balloon Ablation', 'description': 'Arctic Front Advance Cryo Balloon: Mode of ablation determined based on patient and physician preference'}, {'label': 'Radiofrequency Ablation', 'description': 'Contact Force Sensing Radiofrequency Catheter Ablation: Mode of ablation determined based on patient and physician preference'}]}, 'contactsLocationsModule': {'locations': [{'zip': '32501', 'city': 'Pensacola', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Research Manager', 'role': 'CONTACT', 'phone': '850-484-6690'}], 'facility': 'Cardiology Consultants', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}], 'centralContacts': [{'name': 'Research Manager', 'role': 'CONTACT', 'email': 'Jennifer.Lehmann@bhcpns.org', 'phone': '850-484-6690'}], 'overallOfficials': [{'name': 'Sumit Verma, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiology Consultants'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sumit Verma, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sumit Verma, MD', 'investigatorAffiliation': 'Langhorne Cardiology Consultants, Inc.'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-11-22', 'type': 'RELEASE'}, {'date': '2022-01-28', 'type': 'RESET'}, {'date': '2022-03-07', 'type': 'RELEASE'}, {'date': '2022-05-27', 'type': 'RESET'}, {'date': '2023-03-16', 'type': 'RELEASE'}, {'date': '2023-12-13', 'type': 'RESET'}, {'date': '2023-12-18', 'type': 'RELEASE'}, {'date': '2024-05-30', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Sumit Verma, MD, Principal Investigator, Langhorne Cardiology Consultants, Inc.'}}}}