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

Meshalkin Research Institute of Pathology of Circulation

Status: Enrolling

Conditions: Atrial Fibrillation; Pulmonary Hypertension

Treatments: Procedure: Sham pulmonary artery denervation; Procedure: Pulmonary vein isolation; Procedure: Pulmonary artery denervation

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT05856461

MEN_02052023

Details and patient eligibility

About

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

Enrollment: 116 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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116 participants in 2 patient groups

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

Sham Comparator group

Description:

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

Treatment:

Procedure: Sham pulmonary artery denervation

Procedure: Pulmonary vein isolation

Pulmonary vein isolation+pulmonary artery denervation (group 2)

Active Comparator group

Description:

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

Treatment:

Procedure: Pulmonary artery denervation

Procedure: Pulmonary vein isolation