Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-02-09 @ 3:58 PM
Study NCT ID:
NCT02914860
Status:
UNKNOWN
Last Update Posted:
2016-09-26
First Post:
2016-09-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Ganglionated Plexi Activity in Patients With Different Forms of Atrial Fibrillation Guided by SUMO Technology
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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-23', 'studyFirstSubmitDate': '2016-09-08', 'studyFirstSubmitQcDate': '2016-09-23', 'lastUpdatePostDateStruct': {'date': '2016-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'location of discrete uptake accumulations', 'timeFrame': '1 week'}], 'secondaryOutcomes': [{'measure': 'adverse events', 'timeFrame': '1 week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare DUA (discrete uptake accumulations) of mIBG activity in patients with different forms of atrial fibrillation and within a sub-group of healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female patients, age ≥ 18 and ≤ 80 years.\n2. Male or female, age ≥ 50 years in the healthy volunteers group\n3. No heart pathology (for volunteers)\n4. PAF, Pers AF and L-s Pers AF (ECG documented).\n5. LVEF ≥ 50%\n6. Able to provide written informed consent\n7. Able to comply with the requirements of the study\n\nExclusion Criteria:\n\n1. Previous AF ablation therapy\n2. Clinical evidence of active coronary ischemia, significant valvular heart disease, or hemodynamically significant congenital cardiac abnormality\n3. Recent (3 months) myocardial infarction (MI), stroke or transient ischemic attack (except if the patient had a DES implanted stent post-MI it would be one year)\n4. Contra-indication to Iodine-123 Meta-iodobenzylguanidine (123I-mIBG), iodine, isoproterenol\n5. Use of medication for non-cardiac medical conditions that is known to interfere with 123I-mIBG uptake and cannot be safely withheld for at least 24 hours prior to the D-SPECT study procedures'}, 'identificationModule': {'nctId': 'NCT02914860', 'briefTitle': 'Comparison of the Ganglionated Plexi Activity in Patients With Different Forms of Atrial Fibrillation Guided by SUMO Technology', 'organization': {'class': 'NETWORK', 'fullName': 'Meshalkin Research Institute of Pathology of Circulation'}, 'orgStudyIdInfo': {'id': 'Volunteers+AF patients'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Volunteers', 'description': 'Healthy volunteers', 'interventionNames': ['Device: Cardiac CT', 'Device: D-SPECT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PAF', 'description': 'Patients with paroxysmal atrial fibrillation', 'interventionNames': ['Device: Cardiac CT', 'Procedure: Ablation Procedure', 'Device: D-SPECT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pers AF', 'description': 'Patients with persistent atrial fibrillation', 'interventionNames': ['Device: Cardiac CT', 'Procedure: Ablation Procedure', 'Device: D-SPECT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'L-s Pers AF', 'description': 'Patients with long-standing persistent atrial fibrillation', 'interventionNames': ['Device: Cardiac CT', 'Procedure: Ablation Procedure', 'Device: D-SPECT']}], 'interventions': [{'name': 'Cardiac CT', 'type': 'DEVICE', 'description': '* Cardiac CT - contract enhanced cardiac CT according to standard protocol\n* D-SPECT SUMO study - standard SUMO protocol (suggested reduction in mIBG dose and increase in scan time to minimize overall radiation burden)\n* Merge CT and D-SPECT image data to generate SUMO map.', 'armGroupLabels': ['L-s Pers AF', 'PAF', 'Pers AF', 'Volunteers']}, {'name': 'Ablation Procedure', 'type': 'PROCEDURE', 'description': '1. CARTO-reconstruction LA, preferably during same rhythm as SUMO map (generally sinus rhythm) for use during registration of SUMO map in CARTO.\n2. High frequency stimulation (HFS; 20-Hz frequency, 5-ms pulse duration, and 15-mA output) to access positive vagal response (the heart rate decreasing by 50% at baseline).\n3. RF ablation only at points where there is an HFS positive response to SUMO DUA (in sinus rhythm if AF converts)\n4. Target a region of 1.0 - 1.5 cm diameter around the SUMO mIBG DUA\n5. Control HFS\n6. At operator discretion, conventional PVI by circumferential antral ablation according to standard procedures.\n7. Exit and entrance block confirmation\n8. Attempt to induce sustained atrial tachycardia; optional mapping and ablation of post-ablation atrial tachycardia.', 'armGroupLabels': ['L-s Pers AF', 'PAF', 'Pers AF']}, {'name': 'D-SPECT', 'type': 'DEVICE', 'armGroupLabels': ['L-s Pers AF', 'PAF', 'Pers AF', 'Volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '630055', 'city': 'Novosibirsk', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Evgeny Pokushalov, MD, PhD', 'role': 'CONTACT', 'email': 'E.Pokushalov@gmail.com', 'phone': '+79139254858'}, {'name': 'Evgeny Pokushalov, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Alexander Romanov, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Denis Losik', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}], 'centralContacts': [{'name': 'Alexander Romanov', 'role': 'CONTACT', 'email': 'abromanov@mail.ru'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meshalkin Research Institute of Pathology of Circulation', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Spectrum Dynamics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}