A Prospective Randomized Study on the Effect of Oesophageal Temperature Monitoring on the Incidence of Esophageal Lesions After Left Atrial Ablation for the Treatment of Atrial Fibrillation.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Incidence of esophageal lesions
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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).
Outcomes
Primary Outcomes
Incidence of esophageal lesions
Time Frame: Within three days after the ablation procedure.
Incidence of esophageal lesions evaluated by upper digestive endoscopy
Secondary Outcomes
- Difference in the size of the esophageal lesions(Within three days)
- Isolation rate of pulmonary veins at the end of ablation.(End of the procedure)
- Duration of the AF ablation procedure(End of the procedure)
- Rate of recurrence of AF(Six months)
- Maximum esophageal temperature reached during ablation.(During procedure.)
- Incidence of atrio-esophageal fistulas(Six months)
- Persistence of esophageal lesions in the second upper endoscopy.(Between 3 to 30 days of the procedure)
Investigators
Mauricio Ibrahim Scanavacca
Arrhythmia Clinical Unit Director
University of Sao Paulo General Hospital