Trials Sponsors Conditions Drugs Pricing

Conditions

Atrial Fibrillation Cardiac Arrhythmias Esophageal Ulcer

Keywords

atrial-esophageal fistularadiofrequency ablationAtrial 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
+2 more secondary outcomes

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.

Interventions

multipolar and self expandable thermometerDevice

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 thermometerDevice

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

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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:

Sponsors & Collaborators

Circa Scientific, Inc.
Industrycollaborator
University of Sao Paulo General Hospital
Otherlead

Study Sites (1)

Arrhythmia Clinical Unit - Instituto do Coração - HCFMUSP

São Paulo, São Paulo, 05403010, Brazil

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: 40767688DERIVED

MeSH Terms

Conditions

Arrhythmias, CardiacAtrial Fibrillation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Mauricio I Scanavacca, MD, PhD
Instituto do coração - HC/FMUSP
PRINCIPAL INVESTIGATOR

Enrollment

60 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (3)

No probe

Single probe thermometer

Multi-probe

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (3)

No probe

Single probe thermometer

Multi-probe

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations