Back to resultsSafety Procedure Pulmonary Artery Denervation in Addition to Pulmonary Vein Isolation Combined With Ganglionated Plexi Ablation in Patients With Persistent Atrial Fibrillation and Pulmonary Hypertension
Primary Purpose
Atrial Fibrillation, Hypertension, Pulmonary, Heart Diseases
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PV isolation + GP Ablation
PV isolation + GP ablation + Pulmonary GP ablation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Pulmonary Hypertension, Atrial Fibrillation, Pulmonary Arterial Denervation, Safety, Pulmonary Arterial GP Ablation
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
PV isolation + GP Ablation
PV isolation + GP ablation + Pulmonary GP ablation
Arm Description
Outcomes
Primary Outcome Measures
death
all-cause death at 1, 3, 6 months after procedure
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
Secondary Outcome Measures
Mean Pulmonary Artery Pressure
Measured by cardiac echo at 1,3,6 months
recurrence of AF / AFL / AT
Measured by 48-hours ECG at 1,3,6 months
Quality of life
Measured by SF-36 at 1, 6 months
6-minute walk distance
Measured at 1,3,6 months
Pulmonary vascular resistance
Measured by right heart catheterization; The PVR =(mPAP-PCWP)/ carbon monoxide
Assessment of respiratory function
Respiratory function tests at 1, 6 months
Full Information
NCT ID
NCT02298244
First Posted
November 16, 2014
Last Updated
November 19, 2014
Sponsor
Krasnoyarsk Regional Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02298244
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
November 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Krasnoyarsk Regional Hospital
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Hypertension, Pulmonary, Heart Diseases, Arrhythmias, Cardiac, Pathologic Processes, Cardiovascular Diseases, Lung Diseases
Keywords
Pulmonary Hypertension, Atrial Fibrillation, Pulmonary Arterial Denervation, Safety, Pulmonary Arterial GP Ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PV isolation + GP Ablation
Arm Type
Active Comparator
Arm Title
PV isolation + GP ablation + Pulmonary GP ablation
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
PV isolation + GP Ablation
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
PV isolation + GP ablation + Pulmonary GP ablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
death
Description
all-cause death at 1, 3, 6 months after procedure
Time Frame
6 months
Title
Perioperative Complications
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Mean Pulmonary Artery Pressure
Description
Measured by cardiac echo at 1,3,6 months
Time Frame
6 months
Title
recurrence of AF / AFL / AT
Description
Measured by 48-hours ECG at 1,3,6 months
Time Frame
6 months
Title
Quality of life
Description
Measured by SF-36 at 1, 6 months
Time Frame
6 months
Title
6-minute walk distance
Description
Measured at 1,3,6 months
Time Frame
6 months
Title
Pulmonary vascular resistance
Description
Measured by right heart catheterization; The PVR =(mPAP-PCWP)/ carbon monoxide
Time Frame
1 month
Title
Assessment of respiratory function
Description
Respiratory function tests at 1, 6 months
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nikita Shilnikov, MD
Phone
+79135579203
Email
nikita.shilnikoff@gmail.com
12. IPD Sharing Statement
Learn more about this trial
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
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