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

Krasnoyarsk Regional Hospital

Status: Unknown

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

Treatments: Procedure: PV isolation + GP Ablation; Procedure: PV isolation + GP ablation + Pulmonary GP ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT02298244

PDPVI16112014

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

PV isolation + GP Ablation

Active Comparator group

Treatment:

Procedure: PV isolation + GP Ablation

PV isolation + GP ablation + Pulmonary GP ablation

Active Comparator group

Treatment:

Procedure: PV isolation + GP ablation + Pulmonary GP ablation