N/A
Completed N=6
Esophageal Cooling in Radiofrequency Cardiac Ablation
Source: ClinicalTrials.gov NCT03481023 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcomePrimary: Esophageal Mucosal Damage — 1; 1.33333 score on a scale
Summary
This pilot study evaluates the addition of the EnsoETM esophageal cooling device to the radiofrequency (RF) ablation procedure in the treatment of atrial fibrillation in adults. Half of participants will receive the EnsoETM in addition to RF ablation, while the other half will receive luminal esophageal temperature (LET) monitoring during RF ablation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Esophageal Mucosal Damage |
1; 1.33333 | — |
| SECONDARY Number and Percentage of Participants With Treatment-Emergent Adverse Events [Safety and Adverse Events] |
0; 0 | — |
| SECONDARY Presence of Esophageal Submucosal Damage, Indicated by Number of Ulcers as Assessed by Endoscopic Ultrasound (EUS) |
.33; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Subject has an atrial arrhythmia requiring radiofrequency ablation on the posterior aspect of the heart.
- Subject is willing and able to provide informed consent.
- Subject is capable of adhering to the expectations of the study protocol (e.g., attending follow-up visit).
Exclusion Criteria
- Subject has known esophageal deformity, or evidence of esophageal trauma.
- Subject has prior radiation therapy involving the esophagus.
- Subject has a history of esophageal disease (e.g., esophageal varices, cirrhosis, history of esophagectomy, previous swallowing disorders, or achalasia).
- Subject has ingested acidic or caustic poisons.
- Subject is incarcerated.
- Subject is pregnant or plans to become pregnant.
- Subject has a silicone allergy.
- Subject has esophageal bleeding prior to surgical procedure.
Data sourced from ClinicalTrials.gov (NCT03481023). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.