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This Study is designed to determine the outcome and effect of implementation of Esophageal Stylet as a strategy to minimize the risk of esophageal injury during the atrial fibrillation catheter ablation procedure.
There is a clear potential to produce transmural esophageal injury during catheter ablation for AF when employing a lesion set targeting the posterior left atrial wall and pulmonary vein (PV) antra using contemporary large-tip or irrigated-tip catheter ablation systems when endocardial target sites are in close proximity to the esophagus.
It is very likely that a movement by the Esophageal Stylet of only 2 to 3 centimeters from the midline can safely protect the esophagus from thermal injury and will mimic the natural migration of the esophagus itself.
The Stylet proposes to safely facilitate lateral esophageal movement in a manner consistent with the esophagus's own natural migration in order to displace and maintain the esophagus's position away from potential damage resulting from a cardiac ablation procedure in the left atrium or coronary sinus.
The Esophageal Stylet is a thin rigid tube, which will be inserted inside a commonly used nasogastric tube placed inside the esophagus during the ablation. We will use this stylet to move the esophagus away from the site of the ablation about 1-2 centimeters. Other common procedures, such as (Trans-esophageal Echocardiogram), move the esophagus twice this distance with a low risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stylet | Experimental | This group will receive an Esophageal stylet; EsoSure during the ablation procedure in attempt of moving the esophagus away from the ablation site. |
|
| Non-Stylet | No Intervention | This group will receive the ablation procedure without any modifications or interventions. No esophageal stylet will be used in this group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esophageal Stylet - EsoSure | Device | The Esophageal Stylet is a thin rigid tube, which will be inserted inside a commonly used nasogastric tube placed inside the esophagus during the ablation. We will use this stylet to move the esophagus away from the site of the ablation about 1-2 centimeters. |
| Measure | Description | Time Frame |
|---|---|---|
| Esophageal injury or erosion | Decrease of esophageal thermal injury detected by esophageal Pill-Cam | 2-3 days post ablation |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of Atrial Fibrillation | Decrease of atrial fibrillation recurrence after 12 months | 12 Months |
| Total radiofrequency time | Decrease the total time of radiofrequency ablation at the procedure time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medhat Abdelmessih, MD | Contact | (203) 737-1330 | medhat.abdelmessih@yale.edu | |
| Dawn Shaddinger, MSN, CCRN | Contact | (203) 737-3570 | Dawn.Shaddinger@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mark Marieb, MD, FACC | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06520 | United States |
Data will be shared through publications.
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D004937 | Esophageal Fistula |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
|
| Day of ablation procedure |
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |