Status:
UNKNOWN
Esophageal Damage Protection During Pulmonary Vein Ablation. Pilot Study.
Lead Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Conditions:
Atrial Fibrillation
Catheter Ablation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Catheter ablation of atrial fibrillation with electrical isolation of the pulmonary veins in the left atrium carries risk of esophagus thermal lesion. EnsoETM is a device . This study evaluates the be...
Detailed Description
1\. THEORETICAL FRAMEWORK. APPROACH TO THE PROBLEM Background and justification Atrial fibrillation is the most common type of heart arrhythmia. Electrical isolation of the pulmonary veins in the le...
Eligibility Criteria
Inclusion
- Adult patients (older than 18 years of age) subjected to their first pulmonary vein isolation procedure with a catheter or balloon.
Exclusion
- Patients with known esophageal deformity or evidence of esophageal trauma (for example, history of esophagectomy, previous swallowing disorders, achalasia, etc.)
- Patients with known ingestion of acidic or caustic poison in the previous 24 hours.
- Patients weighing less than 40 kg.
- Patients who know they are pregnant.
- Patients under chronic daily treatment with an proton pump inhibitor or any gastrointestinal acid suppressant.
- Patients under 18 years of age.
- Patients who have not signed the informed consent form.
Key Trial Info
Start Date :
March 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03832959
Start Date
March 11 2019
End Date
November 1 2020
Last Update
March 29 2019
Active Locations (1)
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1
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041