Clinical trial NCT03645070: Randomized Study on the Effect of Oesophageal Temperature on the Incidence of Esophageal Lesions After AF Ablation
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrhythmias
Atrial Fibrillation
Esophageal Ulcer
Keywords: atrial-esophageal fistula
radiofrequency ablation
Atrial Fibrillation ablation
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Circa Scientific, Inc.
First posted: 2018-08-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Incidence of esophageal lesions
timeFrame: Within three days after the ablation procedure.
Secondary outcomes:
measure: Rate of recurrence of AF
timeFrame: Six months
measure: Isolation rate of pulmonary veins at the end of ablation.
timeFrame: End of the procedure
measure: Duration of the AF ablation procedure
timeFrame: End of the procedure
measure: Incidence of atrio-esophageal fistulas
timeFrame: Six months
measure: Difference in the size of the esophageal lesions
timeFrame: Within three days
measure: Persistence of esophageal lesions in the second upper endoscopy.
timeFrame: Between 3 to 30 days of the procedure
measure: Maximum esophageal temperature reached during ablation.
timeFrame: During procedure.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Arrhythmia Clinical Unit - Instituto do Coração - HCFMUSP
state: SP
Study officials:
affiliation: Instituto do coração - HC/FMUSP
name: Mauricio I Scanavacca, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: