Oesophageal Protection Study: A Multicentre Study. (IMPACT II)
AF - Atrial Fibrillation, Complication, Atrio-Esophageal Fistula
About this trial
This is an interventional prevention trial for AF - Atrial Fibrillation focused on measuring AF ablation, Radiofrequency, Esophageal thermal injury, atrio-esophageal fistula, Esophageal protection, Esophageal cooling, Esophageal temperature monitoring probe
Eligibility Criteria
Inclusion Criteria:
• All AF patients deemed suitable for AF ablation treatment (under general anaesthetic) as per international guidelines and the patient has already decided on AF ablation treatment and are waiting for this procedure.
Exclusion Criteria:
- Inability to consent for any reason.
- Inability to have the endoscopy follow up for any reason.
- Those in extremities of age (<18 or >85) will not be recruited.
- Those with a history of upper gastrointestinal tract bleeding or at risk of trauma e.g. esophageal varices or stricture which means there is a contraindication for instrumentation of the esophagus for any reason during the ablation.
Sites / Locations
- University of Colorado
- Beth Israel Deaconess Medical Center
- University of PennsylvaniaRecruiting
- Texas Cardiac Arrhythmia Research FoundationRecruiting
- Virginia Commonwealth University
- The Queen Elizabeth Hospital
- Guy's and St Thomas' NHS Foundation Trust
- St.George's HospitalRecruiting
- Royal Brompton & Harefield NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Study group
Control group
Those randomized to the study group will receive the esophageal cooling device- the ensoETM probe, during AF ablation treatment, under general anaesthetic. The cooling device is set to 4 degrees covering ablation of the left atrial posterior wall.
Those randomized to the control group will receive standard of care, which is an esophageal temperature monitoring probe during their AF ablation procedure, under general anaesthetic. The esophageal temperature probe is sited close to the level of ablation (the probe should be at the esophageal level where, opposite this, the ablation catheter is at, in the endocardial aspect of the posterior left atrium).