Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-01-09 @ 10:10 AM
Study NCT ID:
NCT05426759
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2022-06-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Atrial Deganglionation as a Therapy for Cardiac Surgery Patients With Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'barry.obrien@atrianmedical.com', 'phone': '+353872934292', 'title': "Barry O'Brien PhD", 'organization': 'AtriAN Medical Ltd'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Ganglionated Plexi Ablation', 'description': 'Single arm study with Ganglionated Plexi (GP) ablations performed during open-chest cardiothoracic surgery. Ablation is performed using pulsed electric fields, delivered via an epicardial catheter, to selectively ablate the GPs on the epicardial surface of the heart.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Atrial bleed', 'notes': 'During ablation at the ligament of Marshall, a left atrial effusion was noted by the surgeon. This was immediately sutured and no further issues were noted.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Number of Patients in Sinus Rhythm at 12 Months.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ganglionated Plexi Ablation', 'description': 'Single arm study with Ganglionated Plexi (GP) ablations performed during open-chest cardiothoracic surgery. Ablation is performed using pulsed electric fields, delivered via an epicardial catheter, to selectively ablate the GPs on the epicardial surface of the heart.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 month', 'description': 'Patients will be monitored with 24 hour Holter at 12 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Extension of AERP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ganglionated Plexi Ablation', 'description': 'Single arm study with Ganglionated Plexi (GP) ablations performed during open-chest cardiothoracic surgery. Ablation is performed using pulsed electric fields, delivered via an epicardial catheter, to selectively ablate the GPs on the epicardial surface of the heart.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'spread': '41', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0', 'description': 'The acute increase in atrial effective refractory period (AERP) i.e. by comparing AERP values from immediately before and immediately after ablation.', 'unitOfMeasure': 'ms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ganglionated Plexi Ablation', 'description': 'Single arm study with Ganglionated Plexi (GP) ablations performed during open-chest cardiothoracic surgery. Ablation is performed using pulsed electric fields, delivered via an epicardial catheter, to selectively ablate the GPs on the epicardial surface of the heart.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ganglionated Plexi Ablation', 'description': 'Single arm study with Ganglionated Plexi (GP) ablations performed during open-chest cardiothoracic surgery. Ablation is performed using pulsed electric fields, delivered via an epicardial catheter, to selectively ablate the GPs on the epicardial surface of the heart.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '63.6', 'spread': '5.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Left Atrial Diameter', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '0.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Left Ventricular Ejection Fraction', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '48.4', 'spread': '4.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '% (of total left ventricle volume)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hypertension', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Stroke or Transient Ischemic Attack', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Myocardial Infarction', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Paroxysmal Atrial Fibrillation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Valve Disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Beta Blockers', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Anti-Arrhythmic Drugs', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-20', 'size': 1005511, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-06-28T04:22', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-28', 'studyFirstSubmitDate': '2022-06-14', 'resultsFirstSubmitDate': '2024-01-05', 'studyFirstSubmitQcDate': '2022-06-16', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-28', 'studyFirstPostDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Number of Patients in Sinus Rhythm at 12 Months.', 'timeFrame': '12 month', 'description': 'Patients will be monitored with 24 hour Holter at 12 months'}], 'secondaryOutcomes': [{'measure': 'Extension of AERP', 'timeFrame': 'Day 0', 'description': 'The acute increase in atrial effective refractory period (AERP) i.e. by comparing AERP values from immediately before and immediately after ablation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'A prospective single-arm study of ganglionated plexi ablation in cardiothoracic surgery patients with a history of atrial fibrillation.', 'detailedDescription': 'This study assesses the use of electroporation/pulsed field ablation (PFA) to selectively ablate ganglionated plexi in cardiothoracic surgery patients with atrial fibrillation. The PFA treatment will be performed in up to 12 patients with a history of paroxysmal atrial fibrillation. The primary end point will be recurrence of atrial fibrillation out to 1 year follow-ups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age is between 18 and 70 years.\n* Scheduled for open-chest cardiothoracic surgery, for coronary artery bypass grafting and/or aortic valve repair/replacement\n* Have a documented medical history of paroxysmal or early-stage persistent atrial fibrillation within the previous 12 months.\n* Legally competent and willing to sign the informed consent.\n* Life expectancy of at least 2 years.\n\nExclusion Criteria:\n\n* Previous cardiac surgery\n* Prior pericardial interventions\n* Prior endocardial or epicardial pulmonary vein isolation (PVI), or any other invasive AF therapy\n* Previous or existing pericarditis\n* Use of amiodarone within the previous 12 months.\n* Long-standing persistent atrial fibrillation\n* Indication for mitral or tricuspid valve surgery\n* Indication for concomitant left atrial appendage (LAA) ligation or excision\n* History of previous radiation therapy on the thorax\n* History of previous thoracotomy.\n* Prior electrical or mechanical isolation of the Left Atrial Appendage (LAA)\n* The presence of LAA occlusion devices, coronary stents, prosthetic heart valves, pacemakers or implantable cardioverter defibrillators (ICDs)\n* Myocardial infarction within the previous 2 months\n* New York Heart Association (NYHA) Class IV heart failure symptoms\n* Left Ventricular Ejection Fraction (LVEF) \\< 40%, measured by transthoracic echocardiography (TTE)\n* Left atrial diameter \\> 5.0 cm, measured by transthoracic echocardiography (TTE)\n* The presence of left atrial thrombus when examined by transesophageal echocardiography (TEE)\n* The presence of atrial fibrillation (AF) attributable to non-cardiovascular causes such as thyroid disease, electrolyte imbalance/dehydration or other reversible causes\n* Active infection or sepsis as evidenced by increased white blood cell count, elevated C-reactive protein (CRP) or temperature \\> 38.5°C\n* Known or documented carotid stenosis \\> 80%\n* Stroke or transient ischemic attack within the previous 6 months\n* Known or documented epilepsy\n* Pregnancy or child-bearing potential without adequate contraception\n* Circumstances that prevent follow-ups\n* Drug abuse\n* Patients cannot be enrolled in another clinical study'}, 'identificationModule': {'nctId': 'NCT05426759', 'acronym': 'Neural-AF-2', 'briefTitle': 'Atrial Deganglionation as a Therapy for Cardiac Surgery Patients With Atrial Fibrillation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Atrian Medical Ltd.'}, 'officialTitle': 'Atrial Deganglionation as a Therapy for Cardiac Surgery Patients With Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'CIP-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GP Ablation', 'description': 'Single arm study with GP ablations performed during open-chest surgery', 'interventionNames': ['Device: Pulsed Field Ablation of epicardial Ganglionated Plexi.']}], 'interventions': [{'name': 'Pulsed Field Ablation of epicardial Ganglionated Plexi.', 'type': 'DEVICE', 'description': 'Using Pulsed Field Ablation (PFA), delivered via an epicardial catheter, to selectively ablate the ganglionated plexi (GP) on the epicardial surface of the heart.', 'armGroupLabels': ['GP Ablation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Tbilisi Heart & Vascular Clinic', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atrian Medical Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}