Esophageal Cooling for AF Ablation

NCT03691571 | Completed Results FDA Device

• 1 other identifier: 831401
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Number and Percentage of Participants With Esophageal Thermal Injury

  Any injury, occurrence rate measured by EGD

  Day 1 to 2

• Number and Percentage of Participants With Esophageal Injury Based on Severity

  The severity of injury measured by EGD

  Day 1 to 2

Secondary Outcomes (3)

• Posterior Wall Ablation Parameters: Temperature

  Day 0

• Posterior Wall Ablation Parameters

  Day 0

• Occurrence of Acute PV Reconnection

  Day 0

Study Arms (2)

Esophageal Cooling

EXPERIMENTAL

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

Device: Esophageal Cooling

Control

ACTIVE COMPARATOR

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

Device: Control

Interventions

Esophageal Cooling 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.

Also known as: Attune Medical Esophageal Heat Transfer Device, EnsoETM

Esophageal Cooling

Control DEVICE

Standard of care involves standard temperature probe monitoring.

Also known as: Standard of care

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 able to understand and critically review the informed consent form.

You may not qualify if:

• Patients whom are unable to provide informed consent.
• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Attune Medical: collaborator

Study Sites (1)

University of Pennsylvania - Perelman Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Pilot study with a relatively small patient pool; Provides an initial assessment regarding the potential clinical benefit of active esophageal cooling for prevention of thermal injury; Fixed ablation parameters and limited to a single ablation catheter technology; Unclear if findings will be reproducible with different ablation strategies or with different ablation technologies. Larger, multi-center studies are needed.

Results Point of Contact

• Title: Dr. Cory M. Tschabrunn
• Organization: The Hospital of the University of Pennsylvania

coryt@pennmedicine.upenn.edu

215-614-0482

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, blinded single center pilot study

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: October 1, 2018
• Study Start: October 11, 2018
• Primary Completion: March 25, 2020
• Study Completion: February 28, 2021
• Last Updated: October 5, 2022
• Results First Posted: December 21, 2021

Record last verified: 2022-09

Locations

US (1)