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| Name | Class |
|---|---|
| Circa Scientific, Inc. | INDUSTRY |
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It's a randomized pilot study to evaluate the incidence of esophageal thermal injury after left atrial ablation for the treatment of atrial fibrillation according to three different strategies of esophageal temperature monitoring.
These patients will be divided into 3 groups with different strategies of esophageal temperature monitoring: group 1 without monitoring, group 2 monitoring with single probe thermometer and group 3 monitoring with multi-probe thermometer.
The primary end point will be the incidence of esophageal lesions assessed by upper endoscopy.
This is a randomized pilot study on the effect of oesophageal temperature monitoring on the esophageal thermal injury after left atrial ablation for the treatment of atrial fibrillation (AF).
Sixty patients with paroxysmal AF or persistent and without previous AF ablation with indication of AF ablation will be selected to be included at the study.
After informed consent, these patients will be randomized in 3 groups with different strategies of esophageal protection for radiofrequency application in the posterior wall of the left atrium, by randomization in a ratio of 1: 1: 1 between groups.
Group I: no esophageal temperature monitoring technique. Group II: monitoring of esophageal temperature during radiofrequency applications in the posterior wall of the left atrium, with unipolar thermometer.
Group III: oesophageal temperature monitoring during radiofrequency applications in the posterior wall of the left atrium, with a multipolar and self expandable thermometer.
The primary end point will be the incidence of esophageal lesions assessed by upper endoscopy that will be done in all patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No probe | No Intervention | Twenty patients will be allocated to this group, which will have no esophageal temperature monitoring technique | |
| Single probe thermometer | Active Comparator | Twenty patients will be allocated in this group, in which there will be monitoring of esophageal temperature during radiofrequency applications in the posterior wall of the left atrium, with unipolar thermometer. |
|
| Multi-probe | Active Comparator | Twenty patients will be allocated in this group, in which there will be esophageal temperature monitoring during radiofrequency applications in the posterior wall of the left atrium, with a multipolar and self expandable thermometer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multipolar and self expandable thermometer | Device | Will be evaluated if a multipolar and self expandable thermometer is superior to no probe or to single probe thermometer at prevention of esophageal thermal injury. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of esophageal lesions | Incidence of esophageal lesions evaluated by upper digestive endoscopy | Within three days after the ablation procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of recurrence of AF | Rate of recurrence of AF after ablation assessed by ECG, Holter 24 hours or clinically. | Six months |
| Isolation rate of pulmonary veins at the end of ablation. | Will be assessed the rate of pulmonary veins isolation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mauricio I Scanavacca, MD, PhD | Instituto do coraĂ§Ă£o - HC/FMUSP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arrhythmia Clinical Unit - Instituto do CoraĂ§Ă£o - HCFMUSP | SĂ£o Paulo | SĂ£o Paulo | 05403010 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40767688 | Derived | Moura DMC, Pereira RAR, Pisani CF, Wu TC, Chokr MO, Hardy CA, Melo SL, Darrieux FCDC, Hachul DT, Scanavacca MI. Esophageal Temperature Monitoring during Atrial Fibrillation Ablation: A Randomized Study. Arq Bras Cardiol. 2025 Jun;122(7):e20250056. doi: 10.36660/abc.20250056. English, Portuguese. |
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|
| Single probe thermometer | Device | Will be evaluated if a single probe thermometer is superior to a multipolar and self expandable thermometer or to no probe thermometer at prevention of esophageal thermal injury |
|
| End of the procedure |
| Duration of the AF ablation procedure | Will be assessed the duration of the AF ablation that will start at the time of the first radio-frequency lesion until the last one. | End of the procedure |
| Incidence of atrio-esophageal fistulas | Incidence of atrio-esophageal fistulas after AF ablation | Six months |
| Difference in the size of the esophageal lesions | Difference in the size of the esophageal lesions evaluated in the upper digestive endoscopy according to the different groups | Within three days |
| Persistence of esophageal lesions in the second upper endoscopy. | If necessary, the patients with esophageal lesions will be submitted to another upper endoscopy, and the persistence of esophageal lesions will be assessed | Between 3 to 30 days of the procedure |
| Maximum esophageal temperature reached during ablation. | In the groups with esophageal temperature monitoring, the maximum esophageal temperature will be assessed and evaluated between two arms. | During procedure. |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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