Pulmonary Artery Denervation in Patients With Atrial Fibrillation and Group 2 of Pulmonary Hypertension
NCT ID: NCT05856461
Last Updated: 2023-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
116 participants
INTERVENTIONAL
2023-05-22
2025-02-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Pulmonary vein isolation+sham pulmonary artery denervation (group 1)
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
Pulmonary vein isolation
Circumferential pulmonary vein isolation procedure using 3D navigation systems with entrance and exit block verification
Sham pulmonary artery denervation
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
Pulmonary vein isolation+pulmonary artery denervation (group 2)
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
Pulmonary vein isolation
Circumferential pulmonary vein isolation procedure using 3D navigation systems with entrance and exit block verification
Pulmonary artery denervation
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)
Interventions
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Pulmonary vein isolation
Circumferential pulmonary vein isolation procedure using 3D navigation systems with entrance and exit block verification
Sham pulmonary artery denervation
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
Pulmonary artery denervation
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)
Eligibility Criteria
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Inclusion Criteria
* Paroxysmal or persistent atrial fibrillation
* NYHA II-III
* BNP \> 105 pg/ml
* Indications for catheter ablation of atrial fibrillation according guidelines
* LVEF \> 50%
Exclusion Criteria
* Left atrium diameter \> 6 cm
* Planned open heart surgery procedure
* Previous heart valve surgery
* Severe aortic, pulmonary, tricuspid or mitral, valves regurgitation
* Thrombus in the left heart chambers
18 Years
80 Years
ALL
No
Sponsors
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Meshalkin Research Institute of Pathology of Circulation
NETWORK
Responsible Party
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Principal Investigators
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Alexander B Romanov, MD
Role: PRINCIPAL_INVESTIGATOR
E. Meshalkin National Medical Research Center
Locations
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E. Meshalkin National Medical Research Center
Novosibirsk, , Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MEN_02052023
Identifier Type: -
Identifier Source: org_study_id
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