Atrial Fibrillation, Cardiac Arrhythmias, Esophageal Ulcer
Conditions
Keywords
atrial-esophageal fistula, radiofrequency ablation, Atrial Fibrillation ablation
Brief summary
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.
Detailed description
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.
Interventions
DEVICEmultipolar and self expandable thermometer
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.
DEVICESingle probe thermometer
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
Sponsors
Circa Scientific, Inc.
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with paroxysmal or persistent AF, diagnosed by electrocardiogram, 24-hour Holter, or monitors of implantable or non-implantable events, with at least one episode of AF up to 12 months before the procedure. Patients should be willing and able to sign an informed consent form, and to undergo all procedures described in both the study protocol and the consent form.
Exclusion criteria
* Atrial thrombus in the left atrium, history of AF ablation, history of cardiac surgery, contraindication to anticoagulation, permanent AF, New York Heart Association functional class III or IV, stroke in the last 3 months, pregnancy, history blood clotting abnormalities, previous oesophageal surgery, or advanced chronic kidney disease (creatinine \> 2.5 mg/dl).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of esophageal lesions | Within three days after the ablation procedure. | Incidence of esophageal lesions evaluated by upper digestive endoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of recurrence of AF | Six months | Rate of recurrence of AF after ablation assessed by ECG, Holter 24 hours or clinically. |
| Isolation rate of pulmonary veins at the end of ablation. | End of the procedure | Will be assessed the rate of pulmonary veins isolation |
| Duration of the AF ablation procedure | End of the 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. |
| Incidence of atrio-esophageal fistulas | Six months | Incidence of atrio-esophageal fistulas after AF ablation |
| Persistence of esophageal lesions in the second upper endoscopy. | Between 3 to 30 days of the procedure | If necessary, the patients with esophageal lesions will be submitted to another upper endoscopy, and the persistence of esophageal lesions will be assessed |
| Maximum esophageal temperature reached during ablation. | During procedure. | In the groups with esophageal temperature monitoring, the maximum esophageal temperature will be assessed and evaluated between two arms. |
| Difference in the size of the esophageal lesions | Within three days | Difference in the size of the esophageal lesions evaluated in the upper digestive endoscopy according to the different groups |
Countries
Brazil
Outcome results
None listed