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To assess if deviating the esophagus will reduce/eliminate ablation injury to the esophagus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Group | Experimental | Placement of a luminal esophageal temperature probe (LET) and insertion of esolution esophageal retractor. In the intervention group, esolution will be utilized to deviate the esophagus during RF catheter ablation |
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| Control Group | No Intervention | Placement of a luminal esophageal temperature probe (LET) during RF ablation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| esolution catheter | Device | esolution is a catheter-based therapy designed to displace the esophagus away from the source of ablation energy during ablation of AF and to eliminate the risk of esophageal injury |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of esophageal injury attributable to RF ablation energy as noted on post ablation endoscopy | The primary study endpoint is the incidence of esophageal injury attributable to RF ablation energy as noted on post ablation endoscopy | 15-72 hours post-ablation procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OSU | Columbus | Ohio | 43210 | United States |
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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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This is a prospective, multicenter, randomized controlled, double blinded clinical study to assess a reduction of esophageal lesions attributable to radiofrequency (RF) ablation with use of esolution (esophageal retractor) in comparison to conventional therapy (no use of an esophageal retractor). The randomization is with a 1:1 randomization scheme assigning consecutive patients who meet inclusion and exclusion criteria to either: placement of a luminal esophageal temperature probe(LET) (control group); or, to placement of a LET and insertion of esolution esophageal retractor (intervention group). In the control group, there will not be deviation of the esophagus and in the intervention group, esolution will be utilized to deviate the esophagus during RF catheter ablation. All randomized subjects will be included in the intent-to-treat population, which will be used in the primary study analysis.
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The study subjects will not know which treatment arm they were randomized to. Additionally, the gastroenterologist performing the endoscopy post-procedure will also be blinded to the treatment arm.
| D013568 |
| Pathological Conditions, Signs and Symptoms |