Cardiac ArrhythmiasNCT03645070
Randomized Study on the Effect of Oesophageal Temperature on the Incidence of Esophageal Lesions After AF Ablation
A study testing multipolar and self expandable thermometer and Single probe thermometer in people with Cardiac Arrhythmias and Atrial Fibrillation, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiac Arrhythmias, Atrial Fibrillation, Esophageal Ulcer
- What is being tested?
- multipolar and self expandable thermometer and Single probe thermometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 11 Jul 2017to 24 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Arrhythmia Clinical Unit - Instituto do Coração - HCFMUSP
São Paulo, São Paulo, 05403010
About this study
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.
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.
Read the 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
- Being tested
- multipolar and self expandable thermometer, Single probe thermometer
- Keywords
- atrial-esophageal fistula, radiofrequency ablation, Atrial Fibrillation ablation
- Medical subject headings
- Arrhythmias, Cardiac, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multipolar and self expandable thermometerDevice
Also called CIRCA's S-CATH™ Esophageal Temperature Monitoring System
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.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: multipolar and self expandable thermometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of esophageal lesions
Incidence of esophageal lesions evaluated by upper digestive endoscopy
Measured: Within three days after the ablation procedure.
Secondary outcomes (7)
Rate of recurrence of AF
Rate of recurrence of AF after ablation assessed by ECG, Holter 24 hours or clinically.
Measured: Six months
Isolation rate of pulmonary veins at the end of ablation.
Will be assessed the rate of pulmonary veins isolation
Measured: End of the procedure
Duration of the AF ablation procedure
Will be assessed the duration of the AF ablation that will start at the time of the first radio-frequency lesion until the last one.
Measured: End of the procedure
Incidence of atrio-esophageal fistulas
Incidence of atrio-esophageal fistulas after AF ablation
Measured: Six months
Difference in the size of the esophageal lesions
Difference in the size of the esophageal lesions evaluated in the upper digestive endoscopy according to the different groups
Measured: Within three days
Persistence of esophageal lesions in the second upper endoscopy.
If necessary, the patients with esophageal lesions will be submitted to another upper endoscopy, and the persistence of esophageal lesions will be assessed
Measured: Between 3 to 30 days of the procedure
Maximum esophageal temperature reached during ablation.
In the groups with esophageal temperature monitoring, the maximum esophageal temperature will be assessed and evaluated between two arms.
Measured: During procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start11 Jul 2017
- Primary completion1 Oct 2018
- Study completion24 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrhythmiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Circa Scientific, Inc.
- Responsible party
- Principal investigator, Mauricio Ibrahim Scanavacca, University of Sao Paulo General Hospital
- Investigators
- Mauricio I Scanavacca, MD, PhD, Principal investigator, Instituto do coração - HC/FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645070
- Sponsor's protocol ID
- Arrit-Incor-2
- Status last verified
- Jan 2022
- First submitted
- 22 Aug 2018
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 40767688
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03645070
- Acronym / sponsor ID
- Arrit-Incor-2
- Conditions
- Cardiac Arrhythmias, Atrial Fibrillation, Esophageal Ulcer
- Keywords
- atrial-esophageal fistula, radiofrequency ablation, Atrial Fibrillation ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Circa Scientific, Inc.
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 24 Jul 2020 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Single probe thermometerTwenty 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. |
| Multi-probe | Active comparator | Device: multipolar and self expandable thermometerTwenty 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multipolar and self expandable thermometerAlso: CIRCA's S-CATH™ Esophageal Temperature Monitoring SystemWill 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. | Device | Multi-probe |
| Single probe thermometerWill 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 | Device | Single probe thermometer |
Primary outcome
Incidence of esophageal lesions
Time frame: Within three days after the ablation procedure.
Incidence of esophageal lesions evaluated by upper digestive endoscopy
7 secondary outcomes
Rate of recurrence of AF
Time frame: Six months
Isolation rate of pulmonary veins at the end of ablation.
Time frame: End of the procedure
Duration of the AF ablation procedure
Time frame: End of the procedure
Incidence of atrio-esophageal fistulas
Time frame: Six months
Difference in the size of the esophageal lesions
Time frame: Within three days
Persistence of esophageal lesions in the second upper endoscopy.
Time frame: Between 3 to 30 days of the procedure
Maximum esophageal temperature reached during ablation.
Time frame: During procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Derived from this study: PubMed 40767688Moura 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mauricio I Scanavacca, MD, PhD principal investigator
Instituto do coração - HC/FMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multipolar and self expandable thermometer and Single probe thermometer in people with Cardiac Arrhythmias and Atrial Fibrillation, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of esophageal lesions (time frame: Within three days after the ablation procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03645070, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2022.