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Interim analysis: no statistically significant difference in the 2 study arms.
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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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In this randomized double-blind study, the investigators would like to compare standard practice (i.e., use of luminal esophageal temperature monitoring) to that of esophageal deviation during AF ablation. The investigators hypothesize that the strategy of esophageal deviation will result in safer ablation strategy with a reduction in the incidence of esophageal injury as assessed by endoscopy.
Catheter ablation is a commonly performed strategy employed for the treatment of atrial fibrillation. However ablation in the posterior wall of the left atrium can cause thermal injury to the esophagus. When significant thermal injury to the esophagus occurs, two significant complications can occur: 1) the formation of an atrio-esophageal fistula, and 2) gastrointestinal dysmotility. While the former is rate, it is an important complication since it can be fatal. The frequency of the latter complication is less well appreciated, but probably occurs in the range of 1:100 to 1:500. Currently luminal esophageal temperature monitoring is the most commonly employed modality to prevent such injury. However, there are limitations to its use, and atrio-esophageal fistulas have been reported even when using esophageal temperature monitoring. Esophageal deviation using either a TEE or EGD probe has been described in the literature, but the effectiveness and practicality of these techniques are suboptimal, and have therefore precluded their use in routine clinical practice. Recently, we have demonstrated that esophageal deviation is indeed possible using off-the-shelf equipment (a soft thoracic tube and endotracheal stylet) in patients undergoing AF ablation. In this randomized double-blind study, we will compare standard practice (i.e., use of luminal esophageal temperature monitoring) to esophageal deviation during AF ablation. We hypothesize that the strategy of esophageal deviation will result in safer ablation strategy with a reduction in the incidence of esophageal injury as assessed by endoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| esophageal deviation | Experimental | esophageal deviation with IDE device during AF ablation |
|
| temperature monitoring | No Intervention | luminal esophageal temperature monitoring, standard temperature monitoring alone |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| esophageal deviation with IDE device | Device | esophageal deviation during AF ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Presence of Esophageal Injury | The presence of esophageal injury as assessed by upper gastrointestinal endoscopy that is performed within 1 week of the procedure. | within 1 week of AF ablation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Time | Procedure time and fluoroscopic imaging with barium contrast time | day 1, duration ofAF ablation procedure |
| Temperature | Extent of temperature rise on the temperature monitoring probe |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vivek Reddy, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Hospital | Orlando | Florida | 32803 | United States | ||
| Massachusetts General Hospital |
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88 participants were consented, but 2 withdrew prior to randomization
Recruitment began in November 2011, with enrollment beginning February 2012
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| ID | Title | Description |
|---|---|---|
| FG000 | Esophageal Deviation | esophageal deviation with IDE device during AF ablation |
| FG001 | Temperature Monitoring | luminal esophageal standing temperature monitoring alone |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
17 roll-in patients and two pre-procedure withdrawals are removed from the analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Esophageal Deviation | esophageal deviation with IDE device during AF ablation |
| BG001 | Temperature Monitoring | luminal esophageal standing temperature monitoring alone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Presence of Esophageal Injury | The presence of esophageal injury as assessed by upper gastrointestinal endoscopy that is performed within 1 week of the procedure. | 17 roll-in patients and two pre-procedure withdrawals are removed from the analysis. | Posted | Count of Participants | Participants | within 1 week of AF ablation procedure |
|
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17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.
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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 | Esophageal Deviation | esophageal deviation with IDE device during AF ablation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Flutter | Cardiac disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vivek Y Reddy | Icahn School of Medicine at Mount Sinai | 212-241-7114 | vivek.reddy@mountsinai.org |
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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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| during AF ablation procedure (intraoperative) |
| Swallowing Impairment Score | Swallowing impairment during procedure - Scale from 0 (no impairment) to 4 (severe impairment). | during AF ablation procedure (intraoperative) |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Texas Cardiac Arrhythmia Institute | Austin | Texas | 78075 | United States |
| ineligible after signing consent |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Persistent AF | Count of Participants | Participants |
|
| Paroxysmal AF | Count of Participants | Participants |
|
| CHADS Score | CHADS score for Stroke Risk Assessment in Atrial Fibrillation CHADS is a mnemonic for Congestive Heart Failure, Hypertension, Age over 75 years, Diabetes Mellitus, and Stroke or TIA history CHADS Score >2 (CVA risk >5% per year) CHADS Score 1 (CVA risk >4% per year) CHADS Score 0 (low risk) | Mean | Standard Deviation | units on a scale |
|
| History of GERD | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Procedure Time | Procedure time and fluoroscopic imaging with barium contrast time | 17 roll-in patients and two pre-procedure withdrawals are removed from the analysis. | Posted | Mean | Standard Deviation | minutes | day 1, duration ofAF ablation procedure |
|
|
|
| Secondary | Temperature | Extent of temperature rise on the temperature monitoring probe | 17 roll-in patients and two pre-procedure withdrawals are removed from the analysis. | Posted | Mean | Standard Deviation | Celsius | during AF ablation procedure (intraoperative) |
|
|
|
| Secondary | Swallowing Impairment Score | Swallowing impairment during procedure - Scale from 0 (no impairment) to 4 (severe impairment). | 17 roll-in patients and two pre-procedure withdrawals are removed from the analysis. | Posted | Mean | Full Range | units on a scale | during AF ablation procedure (intraoperative) |
|
|
|
| 0 |
| 36 |
| 2 |
| 36 |
| 7 |
| 36 |
| EG001 | Temperature Monitoring | luminal esophageal standing temperature monitoring alone | 0 | 33 | 3 | 33 | 4 | 33 |
| Pericardial Effusion | Cardiac disorders |
|
| Asthma Exacerbation | Respiratory, thoracic and mediastinal disorders |
|
| Groin Hematoma | Renal and urinary disorders |
|
| Nausea with abdominal pain | Gastrointestinal disorders |
|
| Venous Thrombophlebitis | Cardiac disorders |
|
| Atrial Fibrillation | Cardiac disorders |
|
| Acute Bronchitis | Respiratory, thoracic and mediastinal disorders |
|
| Urinary Tract Infection | Renal and urinary disorders |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |