An interventional study of Pulmonary vein isolation and Sham pulmonary artery denervation in Atrial Fibrillation and Pulmonary Hypertension, sponsored by Meshalkin Research Institute of Pathology of Circulation. Recruiting at 1 site in Russian Federation. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-05-25.
Sponsored by Meshalkin Research Institute of Pathology of Circulation · Not applicable, Interventional, and Treatment
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
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 116 is below the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Meshalkin Research Institute of Pathology of Circulation is the lead sponsor of 119 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Procedure: Sham pulmonary artery denervation
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 · Procedure: Pulmonary artery denervation
Circumferential pulmonary vein isolation procedure using 3D navigation systems with entrance and exit block verification
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 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)
Freedom from Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia
Freedom from Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia 3 months after blanking period without antiarrhythmic drugs
Time frame: 12 months
Perioperative complications
Perioperative complications, including Death, Stroke, TIA, myocardial infarction, cardiac tamponade, pulmonary vein stenosis, pulmonary vein stenosis, vascular complications
Time frame: 30 days
Clinical adverse events
Death, Stroke, TIA, myocardial infarction, cardiac arrest, bleedings
Time frame: 12 months
Number of hospitalizations
Hospitalizations due to atrial fibrillation of heart failure
Time frame: 12 months
Mean pulmonary artery pressure
Changes in mean pulmonary artery pressure between groups
Time frame: 12 months
Pulmonary vascular resistance
Changes in the pulmonary vascular resistance between groups
Time frame: 12 months
Pulmonary wedge pressure
Changes in the pulmonary wedge pressure between groups
Time frame: 12 months
Systolic pulmonary artery pressure
Changes in the systolic pulmonary artery pressure between groups
Time frame: 12 months
6-minutes walking distance
Changes in the 6-minutes walking distance between groups
Time frame: 12 months
Atrial fibrillation burden
Changes in the atrial fibrillation burden between groups
Time frame: 12 months
Brain natriuretic peptide
Changes in the brain natriuretic peptide between groups
Time frame: 12 months
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Meshalkin Research Institute of Pathology of Circulation →