Atrial Fibrillation Clinical Trial
Official title:
Evaluation of Esophageal Damage During Conventional Pulmonary Vein Ablation Procedures and Potential Strategies to Protect the Esophagus. Pilot Study.
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 benefit of using the EnsoETM, a device device for esophageal temperature adjustments, during catheter ablation of atrial fibrillation. Half of participants will undergo esophageal temperature adjustment during pulmonary vein catheter ablation, while the other half will undergo catheter ablation with no esophageal temperature adjustment.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | November 2020 |
Est. primary completion date | November 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult patients (older than 18 years of age) subjected to their first pulmonary vein isolation procedure with a catheter or balloon. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital de la Santa Creu i Sant Pau | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
Spain,
10.5935/abc.20160078
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* Note: There are 39 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Presence of esophageal damage | Presence of esophageal lesions will be determined after ablation using esophagogastroscopy. | 1 day | |
Primary | Severity of esophageal damage | Degree of esophageal lesions will be determined after ablation using esophagogastroscopy. Degree of esophageal lesions severity will be determined according to the Zargar endoscopy classification (0, I, IIa, IIb, IIIa, IIIb, IV) | 1 day | |
Primary | Presence of esophageal damage | Presence of esophageal lesions will be determined after ablation using magnetic resonance imaging | <48 hours | |
Secondary | Recurrence of atrial fibrillation | Recurrence of atrial fibrillation after catheter ablation will be determined in the follow-up: clinically, as episodes with high clinical suspicion of being atrial fibrillation despite no ECG documentation documented in ECG or in 24-hours holter monitoring, and defined as an episode lasting more than 30 seconds. 24-hours holter monitoring will be performed 3, 6 and 12 months after catheter ablation |
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