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Atrial FibrillationNCT02664311

A Randomized Comparison of the Use of JET and Conventional Ventilation in Pulmonary Vein Isolation

A study testing Jet Ventilation and Conventional ventilation in people with Atrial Fibrillation, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a randomized prospective study comparing outcomes of pulmonary vein isolation using conventional and jet ventilation. 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?
Jet Ventilation and Conventional ventilation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
21 participants
Where
1 siteUnited States
Study dates
Feb 2013to Oct 2015
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • paroxysmal or persistent AF, first time PVI or left atrial procedure

Who cannot join

  • repeat procedure
  • any contraindications to receiving JET ventilation in the judgement of the treating anesthesiologist

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

Other trials in United States

About this study

This is a randomized prospective study comparing outcomes of pulmonary vein isolation using conventional and jet ventilation.

Read the detailed description

Atrial fibrillation (AF) is the most common cardiac arrhythmia in the United States today. Its incidence increases with age, and the prevalence approaches 10% in patients over 80 years old. Atrial fibrillation increases the risk of strokes, and in some patients is associated with worsened congestive heart failure and quality of life.

Catheter based radiofrequency ablation for atrial fibrillation is an evolving and promising technology, and provides increased freedom from AF and improved quality of life compared with pharmacologic therapy. The technique involves placing catheters through the femoral veins into the heart, including the left atrium. Access to the left atrium is performed by transseptal puncture. Ablation of atrial fibrillation is performed by delivery of radiofrequency energy around the pulmonary veins in order to electrically dissociate them from the atria. This is thought to eliminate common triggers for atrial fibrillation, and therefore reduces the recurrence of AF in some patients.

The ablation procedure is done under general anesthesia and takes 4-8 hours. The first part of the procedure involves creating a computer generated three dimensional model of the left atrium. Once this model is created any patient movement will disrupt its accuracy and interfere with the physician's ability to accurately locate the catheter within the atrium.

The success of AF ablation is dependent upon the creation of an accurate three dimensional model, as well as physicians ability to perform durable lesions and achieve effective isolation of the pulmonary veins. Among the barriers to technical success are the patient's respiratory movement, which impairs catheter stability and the ability to maintain a stable catheter position against the atrium of the heart during ablation. Thus, minimizing respiratory movement during the procedure is critical to procedural outcome.

High frequency jet ventilation (HFJV) is a newer mode of ventilation that relies on very small tidal volumes delivered at high frequency (approximately 80-120 breaths/minute). Initially developed in the critical care setting, HFJV produces less respiratory motion due the small tidal volumes delivered. HFJV has been used successfully in procedures requiring increased stability of the field of interest, such as lithotripsy and percutaneous hepatic and renal radiofrequency ablation as well as stereotactic high single-dose irradiation of stage I non-small cell lung cancer and lung metastases. The initial report of the use of HFJV in radiofrequency catheter ablation (RFCA) of atrial fibrillation was by Goode et al in 2006. In that retrospective analysis, the use of HFJV was associated with a decrease in the number of ablation lesions, due to decreased number of attempts aborted by catheter dislodgement, as well as decreased variation in the size of the left atrium (LA) due to changes in pulmonary pressures associated with conventional ventilation. The incidence of complications was not significantly different between the HFJV and conventionally ventilated patients. More recently, Elkassabany et al. retrospectively reviewed their institutional experience with Jet ventilation, and found that the procedure could be performed safely.

HFJV is increasingly used and may improve procedure efficacy and safety, and may be cost effective. Data however are limited to small series and retrospective reviews. In order to better compare the efficacy and safety of HFJV to conventional ventilation, the investigators propose to conduct a prospective randomized study comparing the use of HJFV and conventional ventilation in patients undergoing pulmonary vein isolation (PVI) at our institution. Our hypothesis is that HFJV, by allowing greater catheter stability and more accurate mapping of the left atrium will allow more effective radiofrequency lesion creation, leading to a quicker procedure, requiring fewer lesions and less ablation and fluoroscopy time with more effective isolation of the pulmonary veins with better short and long term control of AF.

Being tested
Jet Ventilation, Conventional ventilation
Keywords
Pulmonary Vein Isolation, Jet Ventilation, Atrial Fibrillation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Jet VentilationDevice

    Patients are randomized to receive either jet or conventional ventilation during this study

  • Conventional ventilationDevice

    Conventional ventilator - control arm

Study groups in NCT02664311
Study groupRoleWhat they receive
Conventional VentilationPlacebo comparatorPatients receiving conventional ventilation for the duration of this study
Receives: Device: Conventional ventilation
Jet VentilationActive comparatorPatients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium
Receives: Device: Jet Ventilation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Isolation Time

    Comparison of Time (in Minutes) From Obtaining Access to Left Atrium Via Transseptal Catheterization to Demonstrated Isolation of All Pulmonary Veins - hypothesis is that with Jet ventilation there will be a shorter time to pulmonary vein isolation in comparison to conventional ventilation

    Measured: Immediate post procedure

Secondary outcomes (2)
  1. Freedom From AF

    Measured: 1 year

  2. Fluoroscopy Time

    Fluoro time as recorded by RNs from Xray machine

    Measured: Immediate post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2016 (estimated)
  2. Study startFeb 2013
  3. Primary completionOct 2015
  4. Study completionOct 2015

Why it stopped: under enrollment

Resources

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
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02664311
Sponsor's protocol ID
2012P000419
Status last verified
Feb 2017
First submitted
24 Sep 2014
Last updated
10 Apr 2017
Data monitoring committee
Yes
Individual data sharing
Yes: Publication in scientific journal

Questions about this trial

What is this clinical trial studying?

A study testing Jet Ventilation and Conventional ventilation in people with Atrial Fibrillation, run by Beth Israel Deaconess Medical Center at 1 site in United States.

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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 10 Apr 2017. 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 States. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 10 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Isolation Time (time frame: Immediate post procedure). 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 10 Apr 2017.

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