Esophageal Protection Study: A Multicenter Study

NAActive, not recruitingINTERVENTIONAL
Enrollment

152

Participants

Timeline

Start Date

March 10, 2022

Primary Completion Date

May 31, 2026

Study Completion Date

May 31, 2026

Conditions
AF - Atrial FibrillationComplicationAtrio-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.

Trial Locations (6)

19104

University of Pennsylvania, Philadelphia

34102

NCH Research Institute, Naples

66211

Kansas City Cardiac Arrhythmia Research LLC, Overland Park

78705

Texas Cardiac Arrhythmia Research Foundation, Austin

02215

Beth Israel Deaconess Medical Center, Boston

SW170QT

St.George's Hospital, London

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

University of Pennsylvania

OTHER

collaborator

Berry Consultants

OTHER

collaborator

Texas Cardiac Arrhythmia Research Foundation

OTHER

collaborator

Beth Israel Deaconess Medical Center

OTHER

collaborator

Kansas City Cardiac Arrhythmia Research LLC

UNKNOWN

lead

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

INDUSTRY

NCT04577859 - Esophageal Protection Study: A Multicenter Study | Biotech Hunter | Biotech Hunter