N/A
Completed N=42
Esophageal Temperature Management During Cryo AF Ablation (EnsoETM)
Source: ClinicalTrials.gov NCT04079634 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
May 2023
Primary outcomePrimary: Number of Participants With Esophageal Thermal Injury — 8; 1 participants — p=0.02
Summary
The purpose of this pilot study is to determine if esophageal warming using the Attune Medical Esophageal Heat Transfer Device (EnsoETM) limits the frequency or severity of thermal injury during cryoballoon ablation of atrial fibrillation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Esophageal Thermal Injury |
8; 1 | 0.02 sig |
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 willing to provide informed consent.
Exclusion Criteria
- 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 (NCT04079634). 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.