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

• ClinicalTrials.gov Identifier: NCT02664311
• Recruitment Status: Terminated
• First Posted: January 27, 2016
• Results First Posted: April 10, 2017
• Last Update Posted: April 10, 2017
• Sponsor: Beth Israel Deaconess Medical Center
• Information provided by (Responsible Party): Alfred Buxton, Beth Israel Deaconess Medical Center

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Atrial Fibrillation	Device: Jet Ventilation; Device: Conventional ventilation	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Randomized Comparison of the Use of JET and Conventional Ventilation in Pulmonary Vein Isolation
• Study Start Date: February 2013
• Actual Primary Completion Date: October 2015
• Actual Study Completion Date: October 2015

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Conventional Ventilation; Patients receiving conventional ventilation for the duration of this study	Device: Conventional ventilation; Conventional ventilator - control arm
Active Comparator: Jet Ventilation; Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium	Device: Jet Ventilation; Patients are randomized to receive either jet or conventional ventilation during this study

Outcome Measures

Primary Outcome Measures :

1. Isolation Time [ Time Frame: Immediate post procedure ]
   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 :

1. Freedom From AF [ Time Frame: 1 year ]
2. Fluoroscopy Time [ Time Frame: Immediate post-procedure ]
   Fluoro time as recorded by RNs from Xray machine

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Massachusetts

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators

• Study Director: Peter Zimetbaum, MD; Beth Israel Deaconess Medical Center

More Information

• Responsible Party: Alfred Buxton, Principal Investigator, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT02664311
• Other Study ID Numbers: 2012P000419
• First Posted: January 27, 2016
• Results First Posted: April 10, 2017
• Last Update Posted: April 10, 2017
• Last Verified: February 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Publication in scientific journal

Keywords provided by Alfred Buxton, Beth Israel Deaconess Medical Center:

Pulmonary Vein Isolation; Jet Ventilation; Atrial Fibrillation

Additional relevant MeSH terms:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes