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
1 other identifier
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable atrial-fibrillation
Started Jan 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2014
CompletedFirst Posted
Study publicly available on registry
November 21, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedNovember 21, 2014
November 1, 2014
10 months
November 16, 2014
November 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
Mean Pulmonary Artery Pressure
6 months
recurrence of AF / AFL / AT
6 months
Quality of life
6 months
6-minute walk distance
6 months
Pulmonary vascular resistance
1 month
- +1 more secondary outcomes
Study Arms (2)
PV isolation + GP Ablation
ACTIVE COMPARATORPV isolation + GP ablation + Pulmonary GP ablation
ACTIVE COMPARATORInterventions
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
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2014
First Posted
November 21, 2014
Study Start
January 1, 2015
Primary Completion
November 1, 2015
Study Completion
November 1, 2016
Last Updated
November 21, 2014
Record last verified: 2014-11