NCT05856461

Pulmonary Artery Denervation in Patients With Atrial Fibrillation and Group 2 of Pulmonary Hypertension

Pulmonary Artery Denervation+ Atrial Fibrillation Ablation vs Atrial Fibrillation Ablation Only in Patients With Atrial Fibrillation and Group 2 of Pulmonary Hypertension

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Meshalkin Research Institute of Pathology of Circulation · Network
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Atrial Fibrillation
• Pulmonary Hypertension

Interventions

Type	Name	Description
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
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)

Timeline

• Start date: 2023-05-22
• Primary completion: 2024-12-29
• Completion: 2025-02-22
• First posted: 2023-05-12
• Last updated: 2023-05-25

Locations

1 site across 1 country: Russia