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

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation; Pulmonary Hypertension

• Registration Number: NCT05856461
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-03
• Study First Submitted QC: 2023-05-03
• Study First Posted: 2023-05-12
• Study Start: 2023-05-22
• Last Update Submitted: 2023-05-24
• Last Update Posted: 2023-05-25
• Primary Completion: 2024-12-29
• Study Completion: 2025-02-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Perioperative complications	30 days	Perioperative complications, including Death, Stroke, TIA, myocardial infarction, cardiac tamponade, pulmonary vein stenosis, pulmonary vein stenosis, vascular complications
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
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
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

Trial Locations

Locations (1)

E. Meshalkin National Medical Research Center; 🇷🇺 Novosibirsk, Russian Federation