- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02968147
High Frequency Jet Ventilation in AF Ablation
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oxfordshire
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Oxford, Oxfordshire, United Kingdom, OX3 9DU
- John Radcliffe Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Conventional ventilation
Catheter ablation for persistent atrial fibrillation with general anesthesia and conventional ventilation
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General anaesthesia and ventilation with a conventional Phillips intermittent positive pressure ventilator system
|
Experimental: Jet ventilation
Catheter ablation for persistent atrial fibrillation with general anesthesia and high frequency jet ventilation
|
General anaesthesia and ventilation with the Acutronic Monsoon III Jet ventilator system
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with improved lesion power delivery 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 power delivery (force time integral) for each applied lesion.
|
12 months
|
Number of patients with improved lesion creation 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 power delivery (lesion size index) for each applied lesion.
|
12 months
|
Number of patients with improved catheter stability 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 catheter movement (mm movement during ablation) for each applied lesion.
|
12 months
|
Collaborators and Investigators
Investigators
- Study Chair: Yaver Bashir, MA,DM,FRCP, Clinical Director, Consultant Electrophysiologist
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PID11559
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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