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

NCT03645070 | Completed FDA Device

• 1 other identifier: Arrit-Incor-2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrhythmias; Atrial Fibrillation; Esophageal Ulcer

Keywords

atrial-esophageal fistula; radiofrequency ablation; Atrial Fibrillation ablation

Outcome Measures

Primary Outcomes (1)

• Incidence of esophageal lesions

  Incidence of esophageal lesions evaluated by upper digestive endoscopy

  Within three days after the ablation procedure.

Secondary Outcomes (7)

• Rate of recurrence of AF

  Six months

• Isolation rate of pulmonary veins at the end of ablation.

  End of the procedure

• Duration of the AF ablation procedure

  End of the procedure

• Incidence of atrio-esophageal fistulas

  Six months

• Difference in the size of the esophageal lesions

  Within three days

Study Arms (3)

No probe

NO INTERVENTION

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

Single probe thermometer

ACTIVE COMPARATOR

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.

Device: Single probe thermometer

Multi-probe

ACTIVE COMPARATOR

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.

Device: multipolar and self expandable thermometer

Interventions

multipolar and self expandable thermometer 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.

Also known as: CIRCA's S-CATH™ Esophageal Temperature Monitoring System

Multi-probe

Single probe thermometer 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

Single probe thermometer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Circa Scientific, Inc.: collaborator

Study Sites (1)

Arrhythmia Clinical Unit - Instituto do Coração - HCFMUSP

São Paulo, São Paulo, 05403010, Brazil

Location

Related Publications (1)

• 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.

  PMID: 40767688 DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mauricio I Scanavacca, MD, PhD

  Instituto do coração - HC/FMUSP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Arrhythmia Clinical Unit Director

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 24, 2018
• Study Start: July 11, 2017
• Primary Completion: October 1, 2018
• Study Completion: July 24, 2020
• Last Updated: January 10, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)