Assessing esophageal temperature during atrial fibrillation ablation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the impact of two different ablation strategies on esophageal temperature and injury risk during catheter ablation for paroxysmal atrial fibrillation. Patients will be randomly assigned to receive either conventional high-power short-duration ablation or temperature-controlled very-high-power short-duration ablation. The study will measure temperature changes in the esophagus during the procedure and assess any resulting injuries through post-procedure capsule endoscopy. The goal is to determine if the very-high-power approach results in lower esophageal temperatures and fewer injuries compared to the conventional method.

Why it matters

Who can join: the full rules

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."

Where it's running

• Cedars-Sinai Smidt Heart Institute
  Los Angeles, California, United States Recruiting

Study contacts

• Study coordinator: Eric D Braunstein, MD
• Email: Eric.Braunstein@cshs.org
• Phone: 310-248-6679

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.