Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2025-12-30 @ 12:48 AM
Study NCT ID:
NCT06877156
Status:
COMPLETED
Last Update Posted:
2025-12-05
First Post:
2025-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Local Potential Measurement In PFA: A Pilot Study
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-28', 'studyFirstSubmitDate': '2025-03-06', 'studyFirstSubmitQcDate': '2025-03-10', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFAnalyzer output', 'timeFrame': 'From enrollment to hospital discharge typically 1 day', 'description': 'The automated peak-to-peak voltage of the local signal potential output from the PFAnalyzer will be compared to manual measurement of both unipolar and bipolar signals.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation (AF)']}, 'descriptionModule': {'briefSummary': 'This is a pilot study to collect unipolar signal data during a pulsed field ablation study for the treatment of atrial fibrillation and to test the performance of an algorithm designed to measure the local potential of the unipolar signal in real time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Paroxysmal and persistent atrial fibrillation patients referred for a cardiac ablation using pulsed field ablation.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects with paroxysmal or persistent atrial fibrillation (AF) undergoing first time PFA procedure indicated by investigator for the treatment of atrial fibrillation.\n\nMale or non-pregnant female aged ≥18 years.\n\nAble and willing to provide written informed consent prior to any clinical investigation related procedure\n\nExclusion Criteria:\n\n* Pregnant or nursing subjects.\n* Current participation in another investigational drug or device study that interferes with this study.\n* Subjects who, in the opinion of the investigator, are not candidates for this study.\n* Patients who have had a prior ablation procedure\n* Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.\n* Life expectancy is less than 12 months, in the opinion of the investigator\n* Subjects who, in the opinion of the investigator, are considered part of any vulnerable population."}, 'identificationModule': {'nctId': 'NCT06877156', 'briefTitle': 'Local Potential Measurement In PFA: A Pilot Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'CathVision ApS'}, 'officialTitle': 'Unipolar Signal Local Potential Measurement in Pulsed Field Ablation: A Pilot Study', 'orgStudyIdInfo': {'id': 'CVPFA-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'De Novo PFA ablation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Split', 'country': 'Croatia', 'facility': 'KBC Split', 'geoPoint': {'lat': 43.50891, 'lon': 16.43915}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CathVision ApS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}