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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary vein isolation+sham pulmonary artery denervation (group 1) | Sham Comparator | 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+pulmonary artery denervation (group 2) | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary vein isolation | Procedure | Circumferential pulmonary vein isolation procedure using 3D navigation systems with entrance and exit block verification |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia | Freedom from Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia 3 months after blanking period without antiarrhythmic drugs | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative complications | Perioperative complications, including Death, Stroke, TIA, myocardial infarction, cardiac tamponade, pulmonary vein stenosis, pulmonary vein stenosis, vascular complications | 30 days |
| Clinical adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander Romanov, MD | Contact | +73833327655 | abromanov@mail.ru | |
| Vitaly Shabanov, MD | Contact | +73833327655 | v.v.shabanov@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Alexander B Romanov, MD | E. Meshalkin National Medical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| E. Meshalkin National Medical Research Center | Recruiting | Novosibirsk | 630055 | Russia |
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2 parellel groups
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| Sham pulmonary artery denervation | Procedure | 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 | Procedure | 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) |
|
Death, Stroke, TIA, myocardial infarction, cardiac arrest, bleedings
| 12 months |
| Number of hospitalizations | Hospitalizations due to atrial fibrillation of heart failure | 12 months |
| Mean pulmonary artery pressure | Changes in mean pulmonary artery pressure between groups | 12 months |
| Pulmonary vascular resistance | Changes in the pulmonary vascular resistance between groups | 12 months |
| Pulmonary wedge pressure | Changes in the pulmonary wedge pressure between groups | 12 months |
| Systolic pulmonary artery pressure | Changes in the systolic pulmonary artery pressure between groups | 12 months |
| 6-minutes walking distance | Changes in the 6-minutes walking distance between groups | 12 months |
| Atrial fibrillation burden | Changes in the atrial fibrillation burden between groups | 12 months |
| Brain natriuretic peptide | Changes in the brain natriuretic peptide between groups | 12 months |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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