Esophageal Temperature During PVI Using Q-DOT Micro

Launched by CEDARS-SINAI MEDICAL CENTER · Apr 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how two different techniques for a procedure called catheter ablation affect the temperature of the esophagus in patients with a heart condition known as paroxysmal atrial fibrillation. The goal is to see if one method may be safer than the other in terms of preventing injury to the esophagus during the procedure. The study is currently looking for participants aged 18 and older who have been diagnosed with paroxysmal atrial fibrillation and are scheduled for this type of ablation treatment.

If you choose to participate, you will need to sign a consent form and agree to follow the study's procedures. It's important to note that this trial is not open to everyone; for example, if you have had previous heart procedures or certain gastrointestinal conditions, you may not be eligible. Participants will be closely monitored throughout the study, and your safety will be a top priority. Overall, this research aims to improve treatment methods for atrial fibrillation and enhance patient care.

Gender

ALL

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."