Safety Procedure Pulmonary Artery Denervation in Addition to Pulmonary Vein Isolation Combined With Ganglionated Plexi Ablation in Patients With Persistent Atrial Fibrillation and Pulmonary Hypertension

Study Overview
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Brief Summary
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Some patients with a long history of AF develops PH reactive type with an increase in pulmonary vascular resistance due to vasoconstriction or structural changes of the vascular wall. RFA PVI + RFA GP is the gold standard in the treatment of patients with persistent AF, do not respond to optimal therapy. The rear area of the pulmonary artery bifurcation is adjacent to the roof and part of the front of the left atrium. In the projection of this area are ganglionic plexus of the left atrium, the sympathetic nerve fibers of the pulmonary artery and baroreceptors main pulmonary artery.Recent studies have shown that radiofrequency denervation of the pulmonary artery improves the quality of life in patients with PH.

Conditions
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Atrial Fibrillation, Hypertension, Pulmonary, Heart Diseases, Arrhythmias, Cardiac, Pathologic Processes, Cardiovascular Diseases, Lung Diseases

Intervention / Treatment
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* Procedure: PV isolation + GP Ablation
* Procedure: PV isolation + GP ablation + Pulmonary GP ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with symptomatic, drug - refractory AF ( inefficiency 1C or III Class antiarrhythmic drugs), history of AF 6 months or more without the restoration of sinus rhythm. MPAP ≥25 mmHg PCWP≥15 mmHg Pulmonary vascular resistance (PVR). The PVR =(mPAP-PCWP)/ carbon monoxide] > 2.5 woods unit Exclusion Criteria: Left ventricular ejection fraction <35% Diameter LA> 60 mm on transthoracic echocardiography in the M -Mode or volume of LA more than 140 ml Significant regurgitation at the mitral valve Uncorrected congenital heart disease RFA PVI, RFA GP, PADN in history Foregoing heart surgery Life expectancy less than 12 months WHO group I, III, IV, V pulmonary artery hypertension Tricuspid valve stenosis, pulmonary supravalve stenosis. Cancer Pregnancy Thromboembolism LA history Hyperthyroidism.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PV isolation + GP Ablation<br> | Procedure: PV isolation + GP Ablation<br>* In real time builds the 3D card LA using nonfluoroscopic navigation system.Left and right PVs encircle in 1 lesion line by circumferential PV isolation.Radiofrequency energy delivered at 43◦C,35 W,0.5 cm away from the PV ostia at the anterior wall,and reduced to 43◦C,30 W,1 cm away from the PV ostia at the posterior wall,with a saline irrigation speed of 17 ml/min.Each lesion of ablation continuously until the local potential amplitude decreased by >80% or RF energy deliveries exceeded 40 seconds.The endpoint of circumferential PV isolation is PV isolation;this confirm when Lasso mapping show the disappearance of all PV potentials or the dissociation of PV potentials from left atrial activity.To accomplish ganglionated plexi ablation,LA target sites were identified as the anatomic locations where vagal reflexes were evoked by transcatheter HFS.Rectangular electrical stimuli were delivered at a frequency of 50 Hz,output amplitude 15V and pulse duration of 10 ms,for 5 sec<br>|
| Active Comparator: PV isolation + GP ablation + Pulmonary GP ablation<br> | Procedure: PV isolation + GP ablation + Pulmonary GP ablation<br>* The procedure of AF ablation is the same like in the circumferential PV isolation + GP Ablation. 8-Fr sheath is carried through the right heart into the pulmonary artery trunk. Using ablation electrode constructed 3D map of the pulmonary artery trunk and the right and left main branches. Further HFS performed with the tip ablation electrode at the bifurcation of the pulmonary artery and in the ostium of the left and right pulmonary arteries (less than 2 mm distal to the bifurcation) 20 Hz, duration of each stimulus 10 ms. A positive response would be considered an increase in the RR interval of more than 50% of baseline within 10 seconds. In areas with a positive response to HFS, will be performed RFA Efficiency criterion: no previously described responses to HFS in the ablation area. Parameters RFA: 8-10 watts for 60 seconds duration at one point, the irrigation speed of 5 ml / min.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death | all-cause death at 1, 3, 6 months after procedure | 6 months | 
| Perioperative Complications | perforation / dissection at any level, an acute thrombosis in the pulmonary artery, re - hospitalization due to Pulmonary Hypertension, Atrial Fibrillation) immediately after and at 1, 3, 6 months after procedure | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Pulmonary Artery Pressure | Measured by cardiac echo at 1,3,6 months | 6 months | 
| recurrence of AF / AFL / AT | Measured by 48-hours ECG at 1,3,6 months | 6 months | 
| Quality of life | Measured by SF-36 at 1, 6 months | 6 months | 
| 6-minute walk distance | Measured at 1,3,6 months | 6 months | 
| Pulmonary vascular resistance | Measured by right heart catheterization; The PVR =(mPAP-PCWP)/ carbon monoxide | 1 month | 
| Assessment of respiratory function | Respiratory function tests at 1, 6 months | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Hypertension, Atrial Fibrillation, Pulmonary Arterial Denervation, Safety, Pulmonary Arterial GP Ablation