N/A
Completed N=55
Esophageal Cooling for AF Ablation
Source: ClinicalTrials.gov NCT03691571 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcomePrimary: Number and Percentage of Participants With Esophageal Thermal Injury — 8; 5; 13 Participants — p=>.05
Summary
The purpose of this study is to determine if esophageal cooling using the Attune Medical Esophageal Heat Transfer Device (EnsoETM) limits the number or seriousness of injury to the esophagus during atrial fibrillation ablation procedures. The EnsoETM is an FDA cleared device used for temperature management, but is not routinely used during atrial fibrillation ablation procedures.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Percentage of Participants With Esophageal Thermal Injury |
8; 5; 13 | >.05 |
| PRIMARY Number and Percentage of Participants With Esophageal Injury Based on Severity |
1; 2; 6; 0; 1; 3 | — |
| SECONDARY Posterior Wall Ablation Parameters: Temperature |
25.0; 25.7 | 0.11 |
| SECONDARY Posterior Wall Ablation Parameters |
10; 10 | 0.73 |
| SECONDARY Occurrence of Acute PV Reconnection |
6; 1 | 0.10 |
Eligibility Criteria
Inclusion Criteria
- Patients above the age of 18 years old.
- Patients with the diagnosis of atrial fibrillation undergoing clinically indicated de-novo AF ablation procedure.
- Patients must be able to understand and critically review the informed consent form.
Exclusion Criteria
- Patients whom are unable to provide informed consent.
- Patients with contraindication to EGD.
- History of prior AF ablation procedures.
- Significant co-morbidities that preclude standard ablation procedure.
- Patient is ineligible for EnsoETM placement due to:
- Known esophageal deformity or evidence of esophageal trauma (for example history of esophagectomy, previous swallowing disorders, achalasia).
- Known ingestion of acidic or caustic poisons within the prior 24 hours.
- Patients with <40 kg of body mass.
Data sourced from ClinicalTrials.gov (NCT03691571). 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.