NCT06392932

Esophageal Temperature During PVI Using Q-DOT Micro

Esophageal Temperature Dynamics and Injury During Pulmonary Vein Isolation With Temperature Controlled Very-High-Power Short-Duration Lesions Using the Novel Q-DOT Micro Ablation Catheter

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess how two different ablation strategies, using two different ablation catheters during catheter ablation for paroxysmal atrial fibrillation, affect the temperature of the esophagus during ablation, and the risk of injury to the esophagus.

Detailed description

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.

Conditions

• Atrial Fibrillation Paroxysmal

Interventions

Type	Name	Description
DEVICE	QDOT Micro ablation catheter	QDOT Micro ablation catheter
DEVICE	ST SF ablation catheter	ST SF ablation catheter

Timeline

• Start date: 2024-10-04
• Primary completion: 2026-10-01
• Completion: 2027-03-01
• First posted: 2024-05-01
• Last updated: 2025-10-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study