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

Not Applicable

• Conditions: Lung Diseases; Hypertension, Pulmonary; Atrial Fibrillation; Heart Diseases; Arrhythmias, Cardiac; Pathologic Processes; Cardiovascular Diseases
• Interventions: Procedure: PV isolation + GP Ablation; Procedure: PV isolation + GP ablation + Pulmonary GP ablation

• Registration Number: NCT02298244
• Lead Sponsor: Krasnoyarsk Regional Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-11
• Study First Submitted: 2014-11-16
• Study First Submitted QC: 2014-11-19
• Last Update Submitted: 2014-11-19
• Study First Posted: 2014-11-21
• Last Update Posted: 2014-11-21
• Study Start: 2015-01
• Primary Completion: 2015-11
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PV isolation + GP Ablation	PV isolation + GP Ablation	-
PV isolation + GP ablation + Pulmonary GP ablation	PV isolation + GP ablation + Pulmonary GP ablation	-

Primary Outcome Measures

Name	Time	Method
Perioperative Complications	6 months	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
death	6 months	all-cause death at 1, 3, 6 months after procedure

Secondary Outcome Measures

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