High Frequency Jet Ventilation in AF Ablation

NCT02968147 | Completed

• 1 other identifier: PID11559
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; catheter ablation; general anaesthesia

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (3)

• Number of patients with improved lesion power delivery during AF ablation under high frequency jet ventilation

  12 months

• Number of patients with improved lesion creation during AF ablation under high frequency jet ventilation

  12 months

• Number of patients with improved catheter stability during AF ablation under high frequency jet ventilation

  12 months

Study Arms (2)

Conventional ventilation

EXPERIMENTAL

Catheter ablation for persistent atrial fibrillation with general anesthesia and conventional ventilation

Device: Conventional ventilation

Jet ventilation

EXPERIMENTAL

Catheter ablation for persistent atrial fibrillation with general anesthesia and high frequency jet ventilation

Device: High frequency jet ventilation

Interventions

High frequency jet ventilation DEVICE

General anaesthesia and ventilation with the Acutronic Monsoon III Jet ventilator system

Jet ventilation

Conventional ventilation DEVICE

General anaesthesia and ventilation with a conventional Phillips intermittent positive pressure ventilator system

Conventional ventilation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead

Study Sites (1)

John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

High-Frequency Jet Ventilation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

High-Frequency Ventilation; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Yaver Bashir, MA,DM,FRCP

  Clinical Director, Consultant Electrophysiologist

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2016
• First Posted: November 18, 2016
• Study Start: April 7, 2017
• Primary Completion: November 7, 2017
• Study Completion: May 31, 2019
• Last Updated: June 1, 2021

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)