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NCT06392932NARecruiting

Esophageal Temperature During PVI Using Q-DOT Micro

Cedars-Sinai Medical Center

Start Date

10/4/2024

Completion Date

3/1/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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."

Interventions

DEVICE

QDOT Micro ablation catheter

DEVICE

ST SF ablation catheter

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Conditions

Atrial Fibrillation Paroxysmal

Locations

Cedars-Sinai Smidt Heart Institute

Los Angeles, California 90048

United States