Esophageal Temperature During PVI Using Q-DOT Micro

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation Paroxysmal
• Interventions: Device: ST SF ablation catheter; Device: QDOT Micro ablation catheter

• Registration Number: NCT06392932
• Lead Sponsor: Cedars-Sinai Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2024-04-26
• Study First Submitted QC: 2024-04-29
• Study First Posted: 2024-05-01
• Status Verified: 2024-10
• Study Start: 2024-10-04
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08
• Primary Completion: 2025-10
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ST SF Arm	ST SF ablation catheter	Conventional high-power short-duration ablation using the ThermoCool ST SF catheter.
QDOT Arm	QDOT Micro ablation catheter	Temperature-controlled very-high-power short-duration ablation using the QDOT Micro catheter.

Primary Outcome Measures

Name	Time	Method
Maximal change in esophageal temperature during posterior wall isolation.	During ablation procedure.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Cedars-Sinai Smidt Heart Institute; 🇺🇸 Los Angeles, California, United States