Atrial Fibrillation, Pulmonary Hypertension
Conditions
Keywords
Atrial fibrillation, Pulmonary Hypertension, Remote magnetic navigation, Catheter ablation
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
Interventions
PROCEDUREPulmonary vein isolation
Circumferential pulmonary vein isolation procedure using 3D navigation systems with entrance and exit block verification
PROCEDURESham 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
PROCEDUREPulmonary 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)
Sponsors
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
2 parellel groups
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| Pulmonary vascular resistance | 12 months | Changes in the pulmonary vascular resistance between groups |
Countries
Russia
Contacts
Primary ContactAlexander Romanov, MD
Backup ContactVitaly Shabanov, MD
Outcome results
None listed