RecruitingNot Applicable

Esophageal Temperature During PVI Using Q-DOT Micro

United States30 participantsStarted 2024-10-04

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Provision of signed and dated informed consent form
✓. Stated willingness to comply with all study procedures and availability for the duration of the study
✓. Male or female, aged greater than or equal to 18 years
✓. Diagnosed with paroxysmal atrial fibrillation
✓. 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

✕. Patients who have undergone prior left atrial ablation procedures.
✕. 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.
✕. 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)
✕. Any records flagged "break the glass" or "research opt out."

What they're measuring

Maximal change in esophageal temperature during posterior wall isolation.

Timeframe: During ablation procedure.

Trial details

NCT IDNCT06392932

SponsorCedars-Sinai Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10

Contact for this trial

Eric D Braunstein, MD

310-248-6679 Eric.Braunstein@cshs.org

View on ClinicalTrials.gov More Atrial Fibrillation Paroxysmal trials