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under enrollment
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This is a randomized prospective study comparing outcomes of pulmonary vein isolation using conventional and jet ventilation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Ventilation | Placebo Comparator | Patients receiving conventional ventilation for the duration of this study |
|
| Jet Ventilation | Active Comparator | Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jet Ventilation | Device | Patients are randomized to receive either jet or conventional ventilation during this study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Immediate post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From AF | 1 year | |
| Fluoroscopy Time | Fluoro time as recorded by RNs from Xray machine | Immediate post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Zimetbaum, MD | Beth Israel Deaconess Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
Publication in scientific journal
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September 2013-January 2014 at Beth Israel Deaconess Medical Center
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional Ventilation | Patients receiving conventional ventilation for the duration of this study Conventional ventilation: Conventional ventilator - control arm |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Conventional Ventilation | Patients receiving conventional ventilation for the duration of this study Conventional ventilation: Conventional ventilator - control arm |
| BG001 | Jet Ventilation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | minutes | Immediate post procedure |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Conventional Ventilation | Patients receiving conventional ventilation for the duration of this study Conventional ventilation: Conventional ventilator - control arm |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eleanor Greene | Beth Israel Deaconess Medical Center | 617-667-1836 | ergreene@bidmc.harvard.edu |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D006611 | High-Frequency Jet Ventilation |
| ID | Term |
|---|---|
| D006612 | High-Frequency Ventilation |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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| Conventional ventilation | Device | Conventional ventilator - control arm |
|
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
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Atrial fibrillation | Count of Participants | Participants |
|
|
|
| Secondary | Freedom From AF | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Fluoroscopy Time | Fluoro time as recorded by RNs from Xray machine | Posted | Mean | Standard Deviation | minutes | Immediate post-procedure |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | 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 | 0 | 3 | 0 | 3 | 0 | 3 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012138 |
| Respiratory Therapy |