Esophageal Temperature During PVI Using Q-DOT Micro
Recruiting · NCT06392932 · Interventional (participants receive a specific treatment) · Lead sponsor: Cedars-Sinai Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
QDOT Micro ablation catheterST SF ablation catheter
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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."
Where it is running
1 location listed across 1 US state.
- Cedars-Sinai Smidt Heart Institute - Los Angeles, California, United States