Atrial FibrillationNCT02298244
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
A study testing PV isolation + GP Ablation and PV isolation + GP ablation + Pulmonary GP ablation in people with Atrial Fibrillation and Hypertension, Pulmonary, run by Krasnoyarsk Regional Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Hypertension, Pulmonary, Heart Diseases
- What is being tested?
- PV isolation + GP Ablation and PV isolation + GP ablation + Pulmonary GP ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Atrial Fibrillation, Hypertension, Pulmonary, Heart Diseases, Arrhythmias, Cardiac, Pathologic Processes, Cardiovascular Diseases
- Being tested
- PV isolation + GP Ablation, PV isolation + GP ablation + Pulmonary GP ablation
- Keywords
- Pulmonary Hypertension, Atrial Fibrillation, Pulmonary Arterial Denervation, Safety, Pulmonary Arterial GP Ablation
- Medical subject headings
- Atrial Fibrillation, Hypertension, Pulmonary, Heart Diseases, Arrhythmias, Cardiac, Pathologic Processes, Cardiovascular Diseases, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PV isolation + GP AblationProcedure or surgery
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 ablationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| PV isolation + GP Ablation | Active comparator | Not described Receives: Procedure: PV isolation + GP Ablation |
| PV isolation + GP ablation + Pulmonary GP ablation | Active comparator | Not described Receives: Procedure: PV isolation + GP ablation + Pulmonary GP ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
death
all-cause death at 1, 3, 6 months after procedure
Measured: 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
Measured: 6 months
Secondary outcomes (6)
Mean Pulmonary Artery Pressure
Measured by cardiac echo at 1,3,6 months
Measured: 6 months
recurrence of AF / AFL / AT
Measured by 48-hours ECG at 1,3,6 months
Measured: 6 months
Quality of life
Measured by SF-36 at 1, 6 months
Measured: 6 months
6-minute walk distance
Measured at 1,3,6 months
Measured: 6 months
Pulmonary vascular resistance
Measured by right heart catheterization; The PVR =(mPAP-PCWP)/ carbon monoxide
Measured: 1 month
Assessment of respiratory function
Respiratory function tests at 1, 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startJan 2015
- Primary completionNov 2015 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Krasnoyarsk Regional Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298244
- Sponsor's protocol ID
- PDPVI16112014
- Status last verified
- Nov 2014
- First submitted
- 16 Nov 2014
- Last updated
- 21 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02298244
- Acronym / sponsor ID
- PDPVI16112014
- Conditions
- Atrial Fibrillation, Hypertension, Pulmonary, Heart Diseases, Arrhythmias, Cardiac, Pathologic Processes, Cardiovascular Diseases
- Keywords
- Pulmonary Hypertension, Atrial Fibrillation, Pulmonary Arterial Denervation, Safety, Pulmonary Arterial GP Ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Krasnoyarsk Regional HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 21 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PV isolation + GP Ablation | Active comparator | Procedure: PV isolation + GP Ablation |
| PV isolation + GP ablation + Pulmonary GP ablation | Active comparator | Procedure: PV isolation + GP ablation + Pulmonary GP ablation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PV isolation + GP AblationIn 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 | Procedure or surgery | PV isolation + GP Ablation |
| PV isolation + GP ablation + Pulmonary GP ablationThe 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. | Procedure or surgery | PV isolation + GP ablation + Pulmonary GP ablation |
Primary outcome
death
Time frame: 6 months
all-cause death at 1, 3, 6 months after procedure
Perioperative Complications
Time frame: 6 months
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 secondary outcomes
Mean Pulmonary Artery Pressure
Time frame: 6 months
recurrence of AF / AFL / AT
Time frame: 6 months
Quality of life
Time frame: 6 months
6-minute walk distance
Time frame: 6 months
Pulmonary vascular resistance
Time frame: 1 month
Assessment of respiratory function
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing PV isolation + GP Ablation and PV isolation + GP ablation + Pulmonary GP ablation in people with Atrial Fibrillation and Hypertension, Pulmonary, run by Krasnoyarsk Regional Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nikita Shilnikov, MD (+79135579203, nikita.shilnikoff@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2014.