Improving Oesophageal Protection During AF Ablation

NAUnknownINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

February 1, 2019

Primary Completion Date

February 1, 2020

Study Completion Date

February 1, 2020

Conditions
Esophageal Diseases
Interventions
DEVICE

esophageal cooling device (Attune Medical, Chicago, IL)

The esophageal cooling device is a silicone soft tubing that is designed to be inserted into the esophagus. It is currently used clinically to provide whole body cooling or temperature control for intensive care patients (in medically induced coma or general anesthesia). The tubing is established but not been used in the clinical setting of catheter ablation for AF (which is performed under general anesthesia). During application of ablation energy to the posterior left atrial wall, the tubing is cooled to medium-low levels (25 degrees) and this is controlled by the operator.

OTHER

Standard esophageal temperature probe

If the participant is randomized to the control group, then a standard esophageal protection method will be used during their catheter ablation procedure. This comprises of an esophageal temperature probe, inserted whilst the patient is under general anesthesia. If during application of ablation treatment to the posterior left atrial wall causes the esophageal temperature to rise above 38 degrees the ablation treatment is halted in this region. If ablation treatment is incomplete, re-application can be applied again cautiously if temperatures fall back to 37 degrees. Further temperature rise of over 38 degrees at the same region is a contra-indication to further ablation work here.

Trial Locations (1)

SW170QT

RECRUITING

St.George's Hospital, London

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Attune Medical

OTHER

lead

St. George's Hospital, London

OTHER

NCT03819946 - Improving Oesophageal Protection During AF Ablation | Biotech Hunter | Biotech Hunter