ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 37 of 737 for:    Recruiting, Not yet recruiting, Available Studies | "Arrhythmias, Cardiac"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03645070
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : September 3, 2018
Sponsor:
Collaborator:
Circa Scientific
Information provided by (Responsible Party):
Mauricio Ibrahim Scanavacca, University of Sao Paulo General Hospital

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.


Condition or disease Intervention/treatment Phase
Cardiac Arrhythmias Atrial Fibrillation Esophageal Ulcer Device: multipolar and self expandable thermometer Device: Single probe thermometer Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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.
Actual Study Start Date : July 11, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: No probe
Twenty patients will be allocated to this group, which will have no esophageal temperature monitoring technique
Active Comparator: 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.
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

Active Comparator: 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.
Device: 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.
Other Name: CIRCA's S-CATH™ Esophageal Temperature Monitoring System




Primary Outcome Measures :
  1. Incidence of esophageal lesions [ Time Frame: Within three days after the ablation procedure. ]
    Incidence of esophageal lesions evaluated by upper digestive endoscopy


Secondary Outcome Measures :
  1. Rate of recurrence of AF [ Time Frame: Six months ]
    Rate of recurrence of AF after ablation assessed by ECG, Holter 24 hours or clinically.

  2. Isolation rate of pulmonary veins at the end of ablation. [ Time Frame: End of the procedure ]
    Will be assessed the rate of pulmonary veins isolation

  3. Duration of the AF ablation procedure [ Time Frame: End of the 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.

  4. Incidence of atrio-esophageal fistulas [ Time Frame: Six months ]
    Incidence of atrio-esophageal fistulas after AF ablation

  5. Difference in the size of the esophageal lesions [ Time Frame: Within three days ]
    Difference in the size of the esophageal lesions evaluated in the upper digestive endoscopy according to the different groups

  6. Persistence of esophageal lesions in the second upper endoscopy. [ Time Frame: Between 3 to 30 days of the procedure ]
    If necessary, the patients with esophageal lesions will be submitted to another upper endoscopy, and the persistence of esophageal lesions will be assessed

  7. Maximum esophageal temperature reached during ablation. [ Time Frame: During procedure. ]
    In the groups with esophageal temperature monitoring, the maximum esophageal temperature will be assessed and evaluated between two arms.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03645070


Locations
Brazil
Arrhythmia Clinical Unit - Instituto do Coração - HCFMUSP Recruiting
São Paulo, SP, Brazil, 05403010
Contact: Daniel mc Moura, MD    +551126614144    danielmcm@gmail.com   
Contact: Mauricio I Scanavacca, MD, PhD    +55112661-5341    mauricio.scanavacca@gmail.com   
Principal Investigator: Mauricio I Scanavacca, MD, PhD         
Sub-Investigator: Cristiano F Pisani, MD         
Sub-Investigator: Sissy L de Melo, MD, PhD         
Sub-Investigator: Carina A Hardy, MD         
Sub-Investigator: Muhieddine O Chokr, MD         
Sub-Investigator: Daniel MC Moura, MD         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Circa Scientific
Investigators
Principal Investigator: Mauricio I Scanavacca, MD, PhD Instituto do coração - HC/FMUSP

Responsible Party: Mauricio Ibrahim Scanavacca, Arrhythmia Clinical Unit Director, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03645070     History of Changes
Other Study ID Numbers: Arrit-Incor-2
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Mauricio Ibrahim Scanavacca, University of Sao Paulo General Hospital:
atrial-esophageal fistula
radiofrequency ablation
Atrial Fibrillation ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes