Clinical trial NCT03691571: Esophageal Cooling for AF Ablation
Official title: Utility of Esophageal Cooling Therapy for the Prevention of Thermal Injury During Atrial Fibrillation Ablation (eCoolAF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Attune Medical
First posted: 2018-10-01
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, blinded single center pilot study
Primary purpose: PREVENTION

Brief 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.

Detailed description: The EnsoETM is a non-sterile multi-lumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while simultaneously allowing gastric decompression and drainage. Modulation and control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger. Two lumens connect to the external heat exchanger, while a third central lumen provides stomach access for connection to a fluid collection device with low intermittent suction for gastric decompression. The EnsoETM is made of standard medical-grade silicone. It is a single-use, disposable, non-implantable device with an intended duration of use of 72 hours or less. Distilled water circulates within the EnsoETM just like a water blanket.

Eligibility criteria: Inclusion Criteria:

1. Patients above the age of 18 years old.
2. Patients with the diagnosis of atrial fibrillation undergoing clinically indicated de-novo AF ablation procedure.
3. Patients must be able to understand and critically review the informed consent form.

Exclusion Criteria:

1. Patients whom are unable to provide informed consent.
2. Patients with contraindication to EGD.
3. History of prior AF ablation procedures.
4. Significant co-morbidities that preclude standard ablation procedure.
5. 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.

Primary outcomes:
measure: Number and Percentage of Participants With Esophageal Thermal Injury
timeFrame: Day 1 to 2
measure: Number and Percentage of Participants With Esophageal Injury Based on Severity
timeFrame: Day 1 to 2
Secondary outcomes:
measure: Posterior Wall Ablation Parameters: Temperature
timeFrame: Day 0
measure: Posterior Wall Ablation Parameters
timeFrame: Day 0
measure: Occurrence of Acute PV Reconnection
timeFrame: Day 0
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania - Perelman Center
state: Pennsylvania
Study officials:
References: