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

Primary Purpose

Atrial Fibrillation

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Jet Ventilation
Conventional ventilation
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Pulmonary Vein Isolation, Jet Ventilation, Atrial Fibrillation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Conventional Ventilation

Jet Ventilation

Arm Description

Patients receiving conventional ventilation for the duration of this study

Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Freedom From AF
Fluoroscopy Time
Fluoro time as recorded by RNs from Xray machine

Full Information

First Posted
September 24, 2014
Last Updated
February 24, 2017
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02664311
Brief Title
A Randomized Comparison of the Use of JET and Conventional Ventilation in Pulmonary Vein Isolation
Official Title
A Randomized Comparison of the Use of JET and Conventional Ventilation in Pulmonary Vein Isolation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
under enrollment
Study Start Date
February 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Pulmonary Vein Isolation, Jet Ventilation, Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Ventilation
Arm Type
Placebo Comparator
Arm Description
Patients receiving conventional ventilation for the duration of this study
Arm Title
Jet Ventilation
Arm Type
Active Comparator
Arm Description
Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium
Intervention Type
Device
Intervention Name(s)
Jet Ventilation
Intervention Description
Patients are randomized to receive either jet or conventional ventilation during this study
Intervention Type
Device
Intervention Name(s)
Conventional ventilation
Intervention Description
Conventional ventilator - control arm
Primary Outcome Measure Information:
Title
Isolation Time
Description
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
Time Frame
Immediate post procedure
Secondary Outcome Measure Information:
Title
Freedom From AF
Time Frame
1 year
Title
Fluoroscopy Time
Description
Fluoro time as recorded by RNs from Xray machine
Time Frame
Immediate post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: paroxysmal or persistent AF, first time PVI or left atrial procedure Exclusion Criteria: repeat procedure any contraindications to receiving JET ventilation in the judgement of the treating anesthesiologist
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Zimetbaum, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Publication in scientific journal

Learn more about this trial

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

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