Esophageal Temperature During PVI Using Q-DOT Micro

This is a prospective randomized controlled trial, studying patients undergoing ablation involving pulmonary vein isolation for paroxysmal atrial fibrillation. Patients will be assigned to undergo conventional high-power short-duration ablation or temperature-controlled very-high-power short-duration ablation, and esophageal outcomes including temperature changes during ablation and esophageal injury as assessed by post-procedure capsule endoscopy will be compared between the groups. The hypothesis is that very-high-power short-duration ablation will lead to lower rises in esophageal temperature and lower rates of esophageal findings during capsule endoscopy.

• QDOT Micro ablation catheter (Device): QDOT Micro ablation catheter
• ST SF ablation catheter (Device): ST SF ablation catheter

Primary outcomes

• Maximal change in esophageal temperature during posterior wall isolation. [During ablation procedure.]

Secondary outcomes

• Presence of esophageal thermal injury seen on post-procedure capsule endoscopy. [2-4 days after ablation procedure.]
• Presence of procedural complications. [During and immediately following ablation procedure.]

Other outcomes

• Number of RF ablation lesions to performed pulmonary vein isolation. [During ablation procedure.]
• RF time during pulmonary vein isolation. [During ablation procedure.]
• Left atrial dwell time to achieve pulmonary vein isolation. [During ablation procedure.]
• Achievement of first pass pulmonary vein isolation. [During ablation procedure.]

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged greater than or equal to 18 years
4. Diagnosed with paroxysmal atrial fibrillation
5. Undergoing RF catheter ablation for treatment of paroxysmal atrial fibrillation that will involve circumferential point-by-point radiofrequency ablation pulmonary vein isolation with no additional left atrial posterior wall ablation planned

Exclusion Criteria:

1. Patients who have undergone prior left atrial ablation procedures.
2. Patients where the use of the Q-DOT Micro ablation catheter in QMODE+ (i.e. temperature-controlled very-high-power short-duration ablation) is felt to be unsafe.
3. Patients who have contraindications to capsule endoscopy, or GI conditions that may increase the risks of capsule endoscopy (e.g. esophageal strictures, inflammatory bowel disease, etc)
4. Any records flagged "break the glass" or "research opt out."

• Study Protocol and Statistical Analysis Plan (PDF, 2023-08-10)
• Informed Consent Form (PDF, 2024-04-23)