Improving Oesophageal Protection During AF Ablation

Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2019
Overall design This is a randomized controlled trial with 1:1 randomization to study or control group. Treatment/intervention plan and rationale AF patients awaiting to have a planned catheter ablation procedure as their treatment will be eligible for this study. If they participate, there is a 1:1 randomization to study or control group. The study group will have their catheter ablation procedure with utilization of esophageal protection using the cooling tubing device (Attune Medical, Chicago IL). The cooling is controlled by the procedural doctor, with temperatures set in the range of patient safety (for example, cooling at 4 degrees). This device is already in use clinically albeit in a different clinical setting. The device is currently used an intensive care setting to provide whole body cooling. It is designed to be inserted into the esophagus. The temperature control does not allow temperatures to go into the extremes, so preserving patient safety. The control group will have their catheter ablation procedure using standard esophageal protection methods, which is an esophageal temperature probe, to measure for any temperature changes during application of ablation energy. If measured esophageal temperatures reach beyond 38 degrees then ablation is halted in that area. Follow up endoscopy assessment After the ablation procedure, a follow up upper GI endoscopy test will be performed to review for any ablation‐related thermal injury, by a group of endoscopists who are 'blinded' to the randomization of the participant. The follow up endoscopy test will be confirmed with the participant and the timing of this follow up test is within 1 week of their catheter ablation procedure. Clinic follow up The clinic follow up will remain exactly the same as standard care but at the first clinic (this is 12 weeks or 3 months from the ablation procedure) we will review or ask about any lingering gastro‐esophageal symptoms and record this in a basic questionnaire (the GerdQ questionnaire will be used).
Epistemonikos ID: cb3650e0a0b6564a2f45f0ac0f745f4720fb222d
First added on: May 21, 2024