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

Study Overview
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Brief Summary
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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

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

Conditions
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Atrial Fibrillation, Pulmonary Hypertension

Intervention / Treatment
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* Procedure: Pulmonary vein isolation
* Procedure: Sham pulmonary artery denervation
* Procedure: Pulmonary artery denervation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 parellel groups
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Pulmonary vein isolation+sham pulmonary artery denervation (group 1)<br>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<br>* Circumferential pulmonary vein isolation procedure using 3D navigation systems with entrance and exit block verification<br>Procedure: Sham pulmonary artery denervation<br>* 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<br>|
| Active Comparator: Pulmonary vein isolation+pulmonary artery denervation (group 2)<br>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<br>* Circumferential pulmonary vein isolation procedure using 3D navigation systems with entrance and exit block verification<br>Procedure: Pulmonary artery denervation<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia | Freedom from Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia 3 months after blanking period without antiarrhythmic drugs | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative complications | Perioperative complications, including Death, Stroke, TIA, myocardial infarction, cardiac tamponade, pulmonary vein stenosis, pulmonary vein stenosis, vascular complications | 30 days | 
| Clinical adverse events | Death, Stroke, TIA, myocardial infarction, cardiac arrest, bleedings | 12 months | 
| Number of hospitalizations | Hospitalizations due to atrial fibrillation of heart failure | 12 months | 
| Mean pulmonary artery pressure | Changes in mean pulmonary artery pressure between groups | 12 months | 
| Pulmonary vascular resistance | Changes in the pulmonary vascular resistance between groups | 12 months | 
| Pulmonary wedge pressure | Changes in the pulmonary wedge pressure between groups | 12 months | 
| Systolic pulmonary artery pressure | Changes in the systolic pulmonary artery pressure between groups | 12 months | 
| 6-minutes walking distance | Changes in the 6-minutes walking distance between groups | 12 months | 
| Atrial fibrillation burden | Changes in the atrial fibrillation burden between groups | 12 months | 
| Brain natriuretic peptide | Changes in the brain natriuretic peptide between groups | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Pulmonary Hypertension, Remote magnetic navigation, Catheter ablation