Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-30 @ 6:04 PM
Study NCT ID:
NCT05856461
Status:
UNKNOWN
Last Update Posted:
2023-05-25
First Post:
2023-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulmonary Artery Denervation in Patients With Atrial Fibrillation and Group 2 of Pulmonary Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], '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'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 parellel groups'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 116}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2025-02-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-24', 'studyFirstSubmitDate': '2023-05-03', 'studyFirstSubmitQcDate': '2023-05-03', 'lastUpdatePostDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom from Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia', 'timeFrame': '12 months', 'description': 'Freedom from Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia 3 months after blanking period without antiarrhythmic drugs'}], 'secondaryOutcomes': [{'measure': 'Perioperative complications', 'timeFrame': '30 days', 'description': 'Perioperative complications, including Death, Stroke, TIA, myocardial infarction, cardiac tamponade, pulmonary vein stenosis, pulmonary vein stenosis, vascular complications'}, {'measure': 'Clinical adverse events', 'timeFrame': '12 months', 'description': 'Death, Stroke, TIA, myocardial infarction, cardiac arrest, bleedings'}, {'measure': 'Number of hospitalizations', 'timeFrame': '12 months', 'description': 'Hospitalizations due to atrial fibrillation of heart failure'}, {'measure': 'Mean pulmonary artery pressure', 'timeFrame': '12 months', 'description': 'Changes in mean pulmonary artery pressure between groups'}, {'measure': 'Pulmonary vascular resistance', 'timeFrame': '12 months', 'description': 'Changes in the pulmonary vascular resistance between groups'}, {'measure': 'Pulmonary wedge pressure', 'timeFrame': '12 months', 'description': 'Changes in the pulmonary wedge pressure between groups'}, {'measure': 'Systolic pulmonary artery pressure', 'timeFrame': '12 months', 'description': 'Changes in the systolic pulmonary artery pressure between groups'}, {'measure': '6-minutes walking distance', 'timeFrame': '12 months', 'description': 'Changes in the 6-minutes walking distance between groups'}, {'measure': 'Atrial fibrillation burden', 'timeFrame': '12 months', 'description': 'Changes in the atrial fibrillation burden between groups'}, {'measure': 'Brain natriuretic peptide', 'timeFrame': '12 months', 'description': 'Changes in the brain natriuretic peptide between groups'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atrial fibrillation', 'Pulmonary Hypertension', 'Remote magnetic navigation', 'Catheter ablation'], 'conditions': ['Atrial Fibrillation', 'Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'The goal of the study is to compare efficacy and safety of the pulmonary artery denervation procedure combined with atrial fibrillation ablation versus atrial fibrillation ablation alone in patients with paroxysmal and persistent atrial fibrillation and group 2 of the pulmonary hypertension'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mean pulmonary artery pressure \\> 25 mm Hg and pulmonary artery wedge pressure \\> 15 mm Hg by right heart catheterization\n* Paroxysmal or persistent atrial fibrillation\n* NYHA II-III\n* BNP \\> 105 pg/ml\n* Indications for catheter ablation of atrial fibrillation according guidelines\n* LVEF \\> 50%\n\nExclusion Criteria:\n\n* Group 1,3,4 of the pulmonary hypertension\n* Left atrium diameter \\> 6 cm\n* Planned open heart surgery procedure\n* Previous heart valve surgery\n* Severe aortic, pulmonary, tricuspid or mitral, valves regurgitation\n* Thrombus in the left heart chambers'}, 'identificationModule': {'nctId': 'NCT05856461', 'acronym': 'PADN+AF', 'briefTitle': 'Pulmonary Artery Denervation in Patients With Atrial Fibrillation and Group 2 of Pulmonary Hypertension', 'organization': {'class': 'NETWORK', 'fullName': 'Meshalkin Research Institute of Pathology of Circulation'}, 'officialTitle': 'Pulmonary Artery Denervation+ Atrial Fibrillation Ablation vs Atrial Fibrillation Ablation Only in Patients With Atrial Fibrillation and Group 2 of Pulmonary Hypertension', 'orgStudyIdInfo': {'id': 'MEN_02052023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Pulmonary vein isolation+sham pulmonary artery denervation (group 1)', 'description': 'In group 1, standard pulmonary vein isolation will be performed (with manual or remote robotic 3D navigation using radiofrequency energy) with sham pulmonary artery denervation procedure including 3D reconstruction of the pulmonary artery tree and creation of the false ablation point', 'interventionNames': ['Procedure: Pulmonary vein isolation', 'Procedure: Sham pulmonary artery denervation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pulmonary vein isolation+pulmonary artery denervation (group 2)', 'description': 'In group 2, standard pulmonary vein isolation will be performed (with manual or remote robotic 3D navigation using radiofrequency energy) combined with pulmonary artery denervation procedure', 'interventionNames': ['Procedure: Pulmonary vein isolation', 'Procedure: Pulmonary artery denervation']}], 'interventions': [{'name': 'Pulmonary vein isolation', 'type': 'PROCEDURE', 'description': 'Circumferential pulmonary vein isolation procedure using 3D navigation systems with entrance and exit block verification', 'armGroupLabels': ['Pulmonary vein isolation+pulmonary artery denervation (group 2)', 'Pulmonary vein isolation+sham pulmonary artery denervation (group 1)']}, {'name': 'Sham pulmonary artery denervation', 'type': 'PROCEDURE', 'description': 'Sham pulmonary artery denervation procedure includes 3D reconstruction of the right ventricular outflow tract, main, left and right pulmonary arteries with creation of the false ablation points. No true ablation lesions will be performed in the pulmonary artery', 'armGroupLabels': ['Pulmonary vein isolation+sham pulmonary artery denervation (group 1)']}, {'name': 'Pulmonary artery denervation', 'type': 'PROCEDURE', 'description': 'Pulmonary artery denervation procedure includes 3D reconstruction of the right ventricular outflow tract, main, left and right pulmonary arteries and 3 circles of ablation lesions (bifurcation of the main pulmonary artery, left and right pulmonary arteries)', 'armGroupLabels': ['Pulmonary vein isolation+pulmonary artery denervation (group 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '630055', 'city': 'Novosibirsk', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Alexander B Romanov, MD', 'role': 'CONTACT', 'email': 'abromanov@mail.ru', 'phone': '+73833327655'}, {'name': 'Vitaly Shabanov, MD', 'role': 'CONTACT', 'email': 'v.v.shabanov@hotmail.com', 'phone': '+73833327655'}], 'facility': 'E. Meshalkin National Medical Research Center', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}], 'centralContacts': [{'name': 'Alexander Romanov, MD', 'role': 'CONTACT', 'email': 'abromanov@mail.ru', 'phone': '+73833327655'}, {'name': 'Vitaly Shabanov, MD', 'role': 'CONTACT', 'email': 'v.v.shabanov@hotmail.com', 'phone': '+73833327655'}], 'overallOfficials': [{'name': 'Alexander B Romanov, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'E. Meshalkin National Medical Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meshalkin Research Institute of Pathology of Circulation', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}