PADN+AF: Pulmonary Artery Denervation in Patients With Atrial Fibrillation and Group 2 of Pulmonary Hypertension
Study Details
Study Description
Brief Summary
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
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Sham Comparator: 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 |
Procedure: Pulmonary vein isolation
Circumferential pulmonary vein isolation procedure using 3D navigation systems with entrance and exit block verification
Procedure: 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
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Active Comparator: 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 |
Procedure: Pulmonary vein isolation
Circumferential pulmonary vein isolation procedure using 3D navigation systems with entrance and exit block verification
Procedure: 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)
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Outcome Measures
Primary Outcome Measures
- Freedom from Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia [12 months]
Freedom from Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia 3 months after blanking period without antiarrhythmic drugs
Secondary Outcome Measures
- Perioperative complications [30 days]
Perioperative complications, including Death, Stroke, TIA, myocardial infarction, cardiac tamponade, pulmonary vein stenosis, pulmonary vein stenosis, vascular complications
- Clinical adverse events [12 months]
Death, Stroke, TIA, myocardial infarction, cardiac arrest, bleedings
- Number of hospitalizations [12 months]
Hospitalizations due to atrial fibrillation of heart failure
- Mean pulmonary artery pressure [12 months]
Changes in mean pulmonary artery pressure between groups
- Pulmonary vascular resistance [12 months]
Changes in the pulmonary vascular resistance between groups
- Pulmonary wedge pressure [12 months]
Changes in the pulmonary wedge pressure between groups
- Systolic pulmonary artery pressure [12 months]
Changes in the systolic pulmonary artery pressure between groups
- 6-minutes walking distance [12 months]
Changes in the 6-minutes walking distance between groups
- Atrial fibrillation burden [12 months]
Changes in the atrial fibrillation burden between groups
- Brain natriuretic peptide [12 months]
Changes in the brain natriuretic peptide between groups
Eligibility Criteria
Criteria
Inclusion Criteria:
Mean pulmonary artery pressure > 25 mm Hg and pulmonary artery wedge pressure > 15 mm Hg by right heart catheterization 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:
Group 1,3,4 of the pulmonary hypertension 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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | E. Meshalkin National Medical Research Center | Novosibirsk | Russian Federation | 630055 |
Sponsors and Collaborators
- Meshalkin Research Institute of Pathology of Circulation
Investigators
- Principal Investigator: Alexander B Romanov, MD, E. Meshalkin National Medical Research Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MEN_02052023