Assessing esophageal temperature during atrial fibrillation ablation

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

This study is testing if a new high-power ablation method can keep the esophagus cooler and reduce injury risk during heart procedures for people with atrial fibrillation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cedars-Sinai Medical Center (Academic / other)
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT06392932 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with paroxysmal atrial fibrillation who are undergoing RF catheter ablation.

Not a fit: Patients with prior left atrial ablation procedures or contraindications to capsule endoscopy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to safer ablation techniques with reduced risk of esophageal injury for patients with atrial fibrillation.

How similar studies have performed: Other studies have explored ablation techniques, but this specific approach using the Q-DOT Micro catheter is novel.

Eligibility criteria

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 this trial is running

Los Angeles, California

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

Study contacts

• Study coordinator: Eric D Braunstein, MD

Conditions Atrial Fibrillation Paroxysmal; Atrial Fibrillation; Esophageal thermal injury