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

NCT ID: NCT03645070

Last Updated: 2022-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-11
• Study Completion Date: 2020-07-24

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.

Conditions

Cardiac Arrhythmias; Atrial Fibrillation; Esophageal Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

No probe

Twenty patients will be allocated to this group, which will have no esophageal temperature monitoring technique

Group Type: NO_INTERVENTION

No interventions assigned to this group

Single probe thermometer

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.

Group Type: ACTIVE_COMPARATOR

Single probe thermometer

Intervention Type: 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

Multi-probe

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.

Group Type: ACTIVE_COMPARATOR

multipolar and self expandable thermometer

Intervention Type: 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.

Interventions

multipolar 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.

Intervention Type: DEVICE

Single 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

Intervention Type: DEVICE

Other Intervention Names

CIRCA's S-CATH™ Esophageal Temperature Monitoring System

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Circa Scientific, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mauricio Ibrahim Scanavacca

Arrhythmia Clinical Unit Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mauricio I Scanavacca, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto do coração - HC/FMUSP

Locations

Arrhythmia Clinical Unit - Instituto do Coração - HCFMUSP

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 40767688 (View on PubMed)

Other Identifiers

Arrit-Incor-2

Identifier Type: -

Identifier Source: org_study_id