Esophageal Protection Study: A Multicenter Study

Summary

Atrial fibrillation (AF) is a common debilitating heart rhythm condition that can cause heart failure and negatively impact a patient's outlook in terms of symptoms and disability. It is an irregular fast heart rhythm disorder coming from the top chamber of the heart (left atrium). Catheter ablation treatment has been shown to be effective in controlling or eliminating AF and its associated symptoms. This is now a common and effective treatment option for patients suffering with AF. During ablation, thermal energy is applied in the top chamber of the heart (the left atrium) to abolish abnormal electrical signals that cause AF. It is generally a safe procedure, but one potential risk associated with this procedure is damage to the esophagus caused by thermal energy being transmitted to the esophagus from the heart. The esophagus sits just behind the heart chamber where ablation work is performed, about 5mm away, so it is vulnerable to damage. Although the risk of severe esophageal damage is low, if it occurs it can be serious as the patient may become very ill as a result.

In recent studies, it was shown that a more advanced type of esophageal probe (ensoETM) that cools the esophagus during ablation is better at protecting the esophagus from ablation-related injury compared to the standard care temperature monitoring probe currently used. The ensoETM is a CE marked and FDA-cleared device, with an intended purpose of controlling patient temperature and has received marketing authorization from FDA to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures.

The purpose of this study is to determine if the long-term efficacy outcome results obtained in single pilot studies can be replicated in a prospective, multi-center randomized controlled trail comparing the the esophageal cooling probe versus a standard of care esophageal temperature monitoring probe. There is a 50:50 chance of the esophageal cooling probe being used during AF ablation for participants.

Conditions

• AF - Atrial Fibrillation
• Complication
• Atrio-Esophageal Fistula

Interventions

DEVICE

ensoETM. Esophageal cooling during AF ablation

Esophageal cooling during AF ablation: The ensoETM probe is inserted via the orogastric route when the patient is under general anesthesia. The device is set to cool during ablation of the posterior aspect of the left atrium, to protect against transmitted thermal energy and so reduce or prevent esophageal thermal injury.

DEVICE

Esophageal temperature monitoring probe

An esophageal temperature monitoring probe is a typical monitoring device used in standard of care AF ablations. This allows any temperature rise in the esophagus to be detected during ablation. If the temperature reaches \>38 degrees then it is widely recognized that ablation should be halted until the temperatures fall back to below 38 degrees. It therefore has the ability to detect esophageal temperature rise only.

Sponsors & Collaborators

• University of Pennsylvania

  collaborator OTHER

• Berry Consultants

  collaborator OTHER

• Texas Cardiac Arrhythmia Research Foundation

  collaborator OTHER

• Beth Israel Deaconess Medical Center

  collaborator OTHER

• Kansas City Cardiac Arrhythmia Research LLC

  collaborator UNKNOWN

• Advanced Cooling Therapy LLC, d/b/a Attune Medical

  lead INDUSTRY

Principal Investigators

• David Callans, MD · University of Pennsylvania

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-10

Primary Completion

2026-05-31

Completion

2026-05-31

FDA Device

Yes

Countries

• United States
• United Kingdom

Study Locations