Esophageal Temperature Management During Cryo AF Ablation (EnsoETM)

NCT ID: NCT04079634

Last Updated: 2023-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-08
• Study Completion Date: 2022-12-31

Brief 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.

Detailed Description

Catheter ablation of atrial fibrillation (AF) has become a common ablation procedure performed worldwide. The cornerstone of this procedure is pulmonary vein isolation (PVI). PVI can be achieved by multiple methods, the two most common being radiofrequency (RF) and cryoablation. Energy delivery may extend beyond the atrial myocardium and result in damage to adjacent structures, including the esophagus. Atrio-esophageal fistula (AEF) is a rare, but a well-recognized complication of percutaneous AF ablation. The occurrence rate of esophageal injury has varied depending on the reporting center, timing of endoscopy, and the ablation technique utilized. Esophageal ulceration is likely the initial injury that leads to AEF formation and is probably present within hours to days of the ablation procedure.

The Attune Medical Esophageal Heat Transfer Device (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. For this study, the EnsoETM tube will be used during cardiac ablation procedures for the intended indication of patient temperature management using approved settings/parameters as detailed in the product instructions for use document. EnsoETM is an FDA approved device.

This prospective, randomized study will include 40 patients with symptomatic AF undergoing index PVI under general anesthesia at Northwestern Memorial Hospital. Patients will be randomized in a 1:1 fashion with 20 patients (Group A) randomized to undergo the ablation procedure with esophageal warming and the other 20 patients (Group B) will serve as the control group and will not have the EnsoETM device used. All patients will undergo esophagogastroduodenoscopy (EGD) 1-2 days following the ablation procedure to evaluate for esophageal injury.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Treatment

Placement of study device (EnsoETM) for temperature management

Group Type: EXPERIMENTAL

Esophageal warming

Intervention Type: DEVICE

Use of EnsoETM for esophageal warming to limit injury during atrial fibrillation ablation procedure

Control

Placement of standard temperature probe

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: DEVICE

Standard temperature probe monitoring

Interventions

Esophageal warming

Use of EnsoETM for esophageal warming to limit injury during atrial fibrillation ablation procedure

Intervention Type: DEVICE

Control

Standard temperature probe monitoring

Intervention Type: DEVICE

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 willing to provide informed consent.

Exclusion Criteria

1. Patients with contraindication to EGD.

2. History of prior AF ablation procedures.

3. Significant co-morbidities that preclude standard ablation procedure.

4. 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

Sponsors

Attune Medical

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Nishant Verma

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nishant Verma, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STU00209610

Identifier Type: -

Identifier Source: org_study_id