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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02664311
Enrollment
21
Registered
2016-01-27
Start date
2013-02-28
Completion date
2015-10-31
Last updated
2017-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Pulmonary Vein Isolation, Jet Ventilation, Atrial Fibrillation

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.

Interventions

DEVICEJet Ventilation

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

Conventional ventilator - control arm

Sponsors

Beth Israel Deaconess Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Isolation TimeImmediate post procedureComparison 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

MeasureTime frameDescription
Freedom From AF1 year
Fluoroscopy TimeImmediate post-procedureFluoro time as recorded by RNs from Xray machine

Countries

United States

Participant flow

Recruitment details

September 2013-January 2014 at Beth Israel Deaconess Medical Center

Participants by arm

ArmCount
Conventional Ventilation
Patients receiving conventional ventilation for the duration of this study Conventional ventilation: Conventional ventilator - control arm
6
Jet Ventilation
Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium Jet Ventilation: Patients are randomized to receive either jet or conventional ventilation during this study
3
Total9

Baseline characteristics

CharacteristicConventional VentilationTotalJet Ventilation
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
2 Participants3 Participants1 Participants
Age, Categorical
Between 18 and 65 years
4 Participants6 Participants2 Participants
Age, Continuous59 years
STANDARD_DEVIATION 17
59 years
STANDARD_DEVIATION 14
60 years
STANDARD_DEVIATION 9
Atrial fibrillation
Atrial fibrillation - paroxysmal
4 Participants5 Participants1 Participants
Atrial fibrillation
Atrial fibrillation - persistent
2 Participants4 Participants2 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants2 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
5 Participants7 Participants2 Participants
Region of Enrollment
United States
6 participants9 participants3 participants
Sex: Female, Male
Female
1 Participants1 Participants0 Participants
Sex: Female, Male
Male
5 Participants8 Participants3 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 60 / 3
other
Total, other adverse events
0 / 60 / 3
serious
Total, serious adverse events
0 / 60 / 3

Outcome results

Primary

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

Time frame: Immediate post procedure

ArmMeasureValue (MEAN)Dispersion
Conventional VentilationIsolation Time127 minutesStandard Deviation 45
Jet VentilationIsolation Time117 minutesStandard Deviation 55
Secondary

Fluoroscopy Time

Fluoro time as recorded by RNs from Xray machine

Time frame: Immediate post-procedure

ArmMeasureValue (MEAN)Dispersion
Conventional VentilationFluoroscopy Time54 minutesStandard Deviation 11.9
Jet VentilationFluoroscopy Time48 minutesStandard Deviation 18.8
Secondary

Freedom From AF

Time frame: 1 year

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Conventional VentilationFreedom From AF6 Participants
Jet VentilationFreedom From AF3 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026