CompletedNot Applicable

Randomized Study on the Effect of Oesophageal Temperature on the Incidence of Esophageal Lesions After AF Ablation

Brazil60 participantsStarted 2017-07-11

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

What they're measuring

Incidence of esophageal lesions

Timeframe: Within three days after the ablation procedure.

Trial details

NCT IDNCT03645070

SponsorUniversity of Sao Paulo General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-10-01