RecruitingNot ApplicableNCT06392932
Esophageal Temperature During PVI Using Q-DOT Micro
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
Sponsor
Cedars-Sinai Medical Center
Enrollment
30 participants
Start Date
Oct 4, 2024
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- 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 Criteria4
- 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."
Interventions
DEVICEQDOT Micro ablation catheter
QDOT Micro ablation catheter
DEVICEST SF ablation catheter
ST SF ablation catheter
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06392932
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