Esophageal Cooling for AF Ablation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-11

Study Completion Date

2021-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, blinded single center pilot study

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Esophageal Cooling

Patients randomized to Group A receive the EnsoETM (Attune Medical Esophageal Heat Transfer Device).

Group Type EXPERIMENTAL

Esophageal Cooling

Intervention Type DEVICE

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.

Control

Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring).

Group Type ACTIVE_COMPARATOR

Control

Intervention Type DEVICE

Standard of care involves standard temperature probe monitoring.

Interventions

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Esophageal Cooling

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.

Intervention Type DEVICE

Control

Standard of care involves standard temperature probe monitoring.

Intervention Type DEVICE

Other Intervention Names

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Attune Medical Esophageal Heat Transfer Device EnsoETM Standard of care

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No