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
NCT ID: NCT02298244
Last Updated: 2014-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2015-01-31
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PV isolation + GP Ablation
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* MPAP ≥25 mmHg
* PCWP≥15 mmHg
* Pulmonary vascular resistance (PVR). The PVR =(mPAP-PCWP)/ carbon monoxide\] \> 2.5 woods unit
Exclusion Criteria
* 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.
18 Years
70 Years
ALL
Yes
Sponsors
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Krasnoyarsk Regional Hospital
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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PDPVI16112014
Identifier Type: -
Identifier Source: org_study_id