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

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02298244
• Other study ID #: PDPVI16112014
• Status: Not yet recruiting
• Phase: N/A
• First received: November 16, 2014
• Last updated: November 19, 2014
• Start date: January 2015
• Est. completion date: November 2016

Study information

• Verified date: November 2014
• Source: Krasnoyarsk Regional Hospital
• Contact: Nikita Shilnikov, MD
• Phone: +79135579203
• Email: nikita.shilnikoff[@]gmail.com
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: November 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Krasnoyarsk Regional Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death	all-cause death at 1, 3, 6 months after procedure	6 months	Yes
Primary	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	Yes
Secondary	Mean Pulmonary Artery Pressure	Measured by cardiac echo at 1,3,6 months	6 months	No
Secondary	recurrence of AF / AFL / AT	Measured by 48-hours ECG at 1,3,6 months	6 months	No
Secondary	Quality of life	Measured by SF-36 at 1, 6 months	6 months	No
Secondary	6-minute walk distance	Measured at 1,3,6 months	6 months	No
Secondary	Pulmonary vascular resistance	Measured by right heart catheterization; The PVR =(mPAP-PCWP)/ carbon monoxide	1 month	No
Secondary	Assessment of respiratory function	Respiratory function tests at 1, 6 months	6 months	No