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

Sponsor

Krasnoyarsk Regional Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02298244

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Hypertension, Pulmonary Heart Diseases Arrhythmias, Cardiac Pathologic Processes Cardiovascular Diseases Lung Diseases	Procedure: PV isolation + GP Ablation Procedure: PV isolation + GP ablation + Pulmonary GP ablation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

Jan 1, 2015

Anticipated Primary Completion Date :

Nov 1, 2015

Anticipated Study Completion Date :

Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: PV isolation + GP Ablation	Procedure: PV isolation + GP Ablation 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
Active Comparator: PV isolation + GP ablation + Pulmonary GP ablation	Procedure: PV isolation + GP ablation + Pulmonary GP ablation 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.

Arm

Intervention/Treatment

Active Comparator: PV isolation + GP Ablation

Procedure: PV isolation + GP Ablation

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

Active Comparator: PV isolation + GP ablation + Pulmonary GP ablation

Procedure: PV isolation + GP ablation + Pulmonary GP ablation

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.

Outcome Measures

Primary Outcome Measures

death [6 months]
all-cause death at 1, 3, 6 months after procedure
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

Secondary Outcome Measures

Mean Pulmonary Artery Pressure [6 months]
Measured by cardiac echo at 1,3,6 months
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.