Atrial FibrillationNCT02968147
High Frequency Jet Ventilation in AF Ablation
A study testing High frequency jet ventilation and Conventional ventilation in people with Atrial Fibrillation, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Atrial fibrillation (AF) is a cardiac condition that results in patients experiencing an irregular heart beat resulting in symptoms including palpitations and breathlessness. It is known that in most cases, AF is caused by abnormal electrical activity from the top of the left side of the heart (left atrium) which… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- High frequency jet ventilation and Conventional ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Apr 2017to 31 May 2019
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Indication for left atrial catheter ablation for persistent atrial fibrillation
- Patients may be enrolled in other atrial fibrillation trials at Oxford University Hospitals Foundation Trust (unless directly related to ventilation or ablation strategy)
Who cannot join
- Age<18 and >85
- Left ventricular ejection fraction <35%
- Severe lung disease - chronic obstructive pulmonary disease or asthma requiring home oxygen therapy or >3 admissions in preceding 12 months
- Previously failed high frequency jet ventilation due to hypercapnia
- Previous catheter ablation for atrial fibrillation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
About this study
Atrial fibrillation (AF) is a cardiac condition that results in patients experiencing an irregular heart beat resulting in symptoms including palpitations and breathlessness. It is known that in most cases, AF is caused by abnormal electrical activity from the top of the left side of the heart (left atrium) which overrides the heart natural pacemaker in the right atrium. Treatment options include tablets which suppress this abnormal electrical activity, but in some patients these are not sufficient and a procedure is carried out where the areas of abnormal electrical activity are disconnected or 'ablated' to prevent AF from occurring. This treatment is well established and performed worldwide, often under general anaesthetic (GA). The heart and lungs sit close together in the chest, and when the lungs are inflated and deflated during the procedure, the heart also moves. This movement is then transmitted to the special wires or 'catheters' that are placed inside the heart to deliver the ablation treatment. Instability during the treatment can result in ineffective areas of ablation which may later contribute to reduced success of the procedure. Previous research has shown that by reducing the movement of the heart under anaesthesia using alternative techniques can improve catheter stability and improve procedural results. Once such technique is called high frequency jet ventilation (HFJV) which allows the lungs to filled with air using fast and shallow breaths resulting in normal blood oxygen levels with little movement in the heart. This technique has been shown to be safe and effective for this procedure but a direct comparison with conventional ventilation has not been done. The investigators wish to test this and determine if using HFJV improves outcomes during the procedure (i.e. can investigators do the treatment faster and more effectively) and if this translates to better outcomes long term.
Read the detailed description
Catheter ablation for the treatment of the symptoms of fibrillation is now a well-established technique. The technique is complex and commonly undertaken under general anaesthesia. Catheters are introduced into the circulation from the veins at the top of the leg and advanced to the right side of the heart. Using x-ray and ultrasound guidance, the catheters are passed to the left atrium by puncturing the muscle that divides left and right atria (septum). A model of the left atrium is created and this used to guide the movement of an ablation catheter across the tissue and create ablation lesions that lead to electrical isolation of target sites.
Under general anaesthesia, the lungs are inflated and deflated via the ventilator circuit. The expansion of the lungs results in movement of the heart with each respiratory cycle. This leads to catheter instability as the tissue is moved towards and away from a catheter positioned in the left atrium. This movement is particularly marked at the back of the left atrium. This instability can lead to real time variation in the delivery of energy which can result in ineffective lesions. These will then translate acutely to incomplete isolation and the need for further ablation (thereby increasing procedure time) and later into reconnection of tissue which can result in repeated procedures being needed to achieve an effective outcome. Each procedure carries risk of minor and major complications therefore measures to improve first time success are critical.
Current research supports the use of steerable catheter sheaths (tubes through which the catheters travel to the atria) and 3 dimensional mapping in improving ablation parameters. Data also exists demonstrating significant variation in catheter contact despite these measures. In order to improve catheter stability further, changes to the mode of ventilation has been studied. Small studies have shown that by stopping cardiac movement altogether by transiently stopping ventilation (apnoea) catheter stability is improved and ablation is more effective. However, intermittent apnoea is not an effective method of ventilation in long cases. An alternative is high frequency jet ventilation. This is where the lungs are ventilated with low volume, high speed and high pressure breaths. This technique is well established and has safety data in upper airway surgery and liver radiology procedures where movement of airways and diaphragm needs to be minimized. In view of this, this technique has been studied in AF ablation and has been shown to improve catheter stability and energy delivery with no increase in complications related to the mode of ventilation. However, existing studies have focused mainly in paroxysmal AF patients (where less ablation is needed) and conducted in a non randomized trial design.
The investigators wish to research the use of HFJV in patients undergoing ablation for persistent AF in a prospective and randomised trial to answer the primary and secondary questions shown below.
- Conditions
- Atrial Fibrillation
- Being tested
- High frequency jet ventilation, Conventional ventilation
- Keywords
- atrial fibrillation, catheter ablation, general anaesthesia
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High frequency jet ventilationDevice
General anaesthesia and ventilation with the Acutronic Monsoon III Jet ventilator system
Conventional ventilationDevice
General anaesthesia and ventilation with a conventional Phillips intermittent positive pressure ventilator system
| Study group | Role | What they receive |
|---|---|---|
| Conventional ventilation | Experimental | Catheter ablation for persistent atrial fibrillation with general anesthesia and conventional ventilation Receives: Device: Conventional ventilation |
| Jet ventilation | Experimental | Catheter ablation for persistent atrial fibrillation with general anesthesia and high frequency jet ventilation Receives: Device: High frequency jet ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with improved catheter contact force during AF ablation under high frequency jet ventilation
Data will be extracted from the St Jude Medical Velocity/Tacticath system to determine average force (grams/sec) for each applied lesion.
Measured: 12 months
Secondary outcomes (3)
Number of patients with improved lesion power delivery during AF ablation under high frequency jet ventilation
Data will be extracted from the St Jude Medical Velocity/Tacticath system to determine power delivery (force time integral) for each applied lesion.
Measured: 12 months
Number of patients with improved lesion creation during AF ablation under high frequency jet ventilation
Data will be extracted from the St Jude Medical Velocity/Tacticath system to determine power delivery (lesion size index) for each applied lesion.
Measured: 12 months
Number of patients with improved catheter stability during AF ablation under high frequency jet ventilation
Data will be extracted from the St Jude Medical Velocity/Tacticath system to determine catheter movement (mm movement during ablation) for each applied lesion.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study start7 Apr 2017
- Primary completion7 Nov 2017
- Study completion31 May 2019
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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yaver Bashir, MA,DM,FRCP, Study chair, Clinical Director, Consultant Electrophysiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968147
- Sponsor's protocol ID
- PID11559
- Status last verified
- Nov 2016
- First submitted
- 1 Feb 2016
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Frequency Jet Ventilation in AF Ablation
- ClinicalTrials.gov ID
- NCT02968147
- Acronym / sponsor ID
- PID11559
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, catheter ablation, general anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 7 Apr 2017 (actual)
- Primary completion
- 7 Nov 2017 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 18 Nov 2016 (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.
Atrial fibrillation (AF) is a cardiac condition that results in patients experiencing an irregular heart beat resulting in symptoms including palpitations and breathlessness. It is known that in most cases, AF is caused by abnormal electrical activity from the top of the left side of the heart (left atrium) which overrides the heart natural pacemaker in the right atrium. Treatment options include tablets which suppress this abnormal electrical activity, but in some patients these are not sufficient and a procedure is carried out where the areas of abnormal electrical activity are disconnected or 'ablated' to prevent AF from occurring. This treatment is well established and performed worldwide, often under general anaesthetic (GA). The heart and lungs sit close together in the chest, and when the lungs are inflated and deflated during the procedure, the heart also moves. This movement is then transmitted to the special wires or 'catheters' that are placed inside the heart to deliver the ablation treatment. Instability during the treatment can result in ineffective areas of ablation which may later contribute to reduced success of the procedure. Previous research has shown that by reducing the movement of the heart under anaesthesia using alternative techniques can improve catheter stability and improve procedural results. Once such technique is called high frequency jet ventilation (HFJV) which allows the lungs to filled with air using fast and shallow breaths resulting in normal blood oxygen levels with little movement in the heart. This technique has been shown to be safe and effective for this procedure but a direct comparison with conventional ventilation has not been done. The investigators wish to test this and determine if using HFJV improves outcomes during the procedure (i.e. can investigators do the treatment faster and more effectively) and if this translates to better outcomes long term.
Detailed description
Catheter ablation for the treatment of the symptoms of fibrillation is now a well-established technique. The technique is complex and commonly undertaken under general anaesthesia. Catheters are introduced into the circulation from the veins at the top of the leg and advanced to the right side of the heart. Using x-ray and ultrasound guidance, the catheters are passed to the left atrium by puncturing the muscle that divides left and right atria (septum). A model of the left atrium is created and this used to guide the movement of an ablation catheter across the tissue and create ablation lesions that lead to electrical isolation of target sites.
Under general anaesthesia, the lungs are inflated and deflated via the ventilator circuit. The expansion of the lungs results in movement of the heart with each respiratory cycle. This leads to catheter instability as the tissue is moved towards and away from a catheter positioned in the left atrium. This movement is particularly marked at the back of the left atrium. This instability can lead to real time variation in the delivery of energy which can result in ineffective lesions. These will then translate acutely to incomplete isolation and the need for further ablation (thereby increasing procedure time) and later into reconnection of tissue which can result in repeated procedures being needed to achieve an effective outcome. Each procedure carries risk of minor and major complications therefore measures to improve first time success are critical.
Current research supports the use of steerable catheter sheaths (tubes through which the catheters travel to the atria) and 3 dimensional mapping in improving ablation parameters. Data also exists demonstrating significant variation in catheter contact despite these measures. In order to improve catheter stability further, changes to the mode of ventilation has been studied. Small studies have shown that by stopping cardiac movement altogether by transiently stopping ventilation (apnoea) catheter stability is improved and ablation is more effective. However, intermittent apnoea is not an effective method of ventilation in long cases. An alternative is high frequency jet ventilation. This is where the lungs are ventilated with low volume, high speed and high pressure breaths. This technique is well established and has safety data in upper airway surgery and liver radiology procedures where movement of airways and diaphragm needs to be minimized. In view of this, this technique has been studied in AF ablation and has been shown to improve catheter stability and energy delivery with no increase in complications related to the mode of ventilation. However, existing studies have focused mainly in paroxysmal AF patients (where less ablation is needed) and conducted in a non randomized trial design.
The investigators wish to research the use of HFJV in patients undergoing ablation for persistent AF in a prospective and randomised trial to answer the primary and secondary questions shown below.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional ventilation | Experimental | Device: Conventional ventilationCatheter ablation for persistent atrial fibrillation with general anesthesia and conventional ventilation |
| Jet ventilation | Experimental | Device: High frequency jet ventilationCatheter ablation for persistent atrial fibrillation with general anesthesia and high frequency jet ventilation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Indication for left atrial catheter ablation for persistent atrial fibrillation
- Patients may be enrolled in other atrial fibrillation trials at Oxford University Hospitals Foundation Trust (unless directly related to ventilation or ablation strategy)
Key exclusion criteria (5 listed)
- Age<18 and >85
- Left ventricular ejection fraction <35%
- Severe lung disease - chronic obstructive pulmonary disease or asthma requiring home oxygen therapy or >3 admissions in preceding 12 months
- Previously failed high frequency jet ventilation due to hypercapnia
- Previous catheter ablation for atrial fibrillation
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 |
|---|---|---|
| High frequency jet ventilationGeneral anaesthesia and ventilation with the Acutronic Monsoon III Jet ventilator system | Device | Jet ventilation |
| Conventional ventilationGeneral anaesthesia and ventilation with a conventional Phillips intermittent positive pressure ventilator system | Device | Conventional ventilation |
Primary outcome
Number of patients with improved catheter contact force during AF ablation under high frequency jet ventilation
Time frame: 12 months
Data will be extracted from the St Jude Medical Velocity/Tacticath system to determine average force (grams/sec) for each applied lesion.
3 secondary outcomes
Number of patients with improved lesion power delivery during AF ablation under high frequency jet ventilation
Time frame: 12 months
Number of patients with improved lesion creation during AF ablation under high frequency jet ventilation
Time frame: 12 months
Number of patients with improved catheter stability during AF ablation under high frequency jet ventilation
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Yaver Bashir, MA,DM,FRCP study chair
Clinical Director, Consultant Electrophysiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High frequency jet ventilation and Conventional ventilation in people with Atrial Fibrillation, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
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 5 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: finished, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with improved catheter contact force during AF ablation under high frequency jet ventilation (time frame: 12 months). 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 1 Jun 2021.