PADN+AF: Pulmonary Artery Denervation in Patients With Atrial Fibrillation and Group 2 of Pulmonary Hypertension

Sponsor

Meshalkin Research Institute of Pathology of Circulation (Other)

Overall Status

Recruiting

CT.gov ID

NCT05856461

Collaborator

(none)

116

Enrollment

Location

Arms

21.7

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Pulmonary Hypertension	Procedure: Pulmonary vein isolation Procedure: Sham pulmonary artery denervation Procedure: Pulmonary artery denervation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

116 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

2 parellel groups2 parellel groups

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 2, 2023

Anticipated Primary Completion Date :

Dec 29, 2024

Anticipated Study Completion Date :

Feb 22, 2025

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Pulmonary vein isolation+sham pulmonary artery denervation (group 1) 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 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
Active Comparator: Pulmonary vein isolation+pulmonary artery denervation (group 2) 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 Circumferential pulmonary vein isolation procedure using 3D navigation systems with entrance and exit block verification 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)

Arm

Intervention/Treatment

Sham Comparator: Pulmonary vein isolation+sham pulmonary artery denervation (group 1)

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

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

Active Comparator: Pulmonary vein isolation+pulmonary artery denervation (group 2)

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

Circumferential pulmonary vein isolation procedure using 3D navigation systems with entrance and exit block verification

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)

Outcome Measures

Primary Outcome Measures

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

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 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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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