Actively Recruiting
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
Led by Cedars-Sinai Medical Center · Updated on 2025-10-28
30
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
C
Cedars-Sinai Medical Center
Lead Sponsor
B
Biosense Webster, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to study patients with paroxysmal atrial fibrillation undergoing catheter ablation to compare two different ablation strategies. The trial evaluates how these strategies affect esophageal temperature during ablation and the risk of injury to the esophagus. The study focuses on pulmonary vein isolation using either conventional or very-high-power short-duration ablation methods. Participants will be randomly assigned to one of two groups: one receiving temperature-controlled very-high-power short-duration ablation with the QDOT Micro catheter, and the other undergoing conventional high-power short-duration ablation using the ThermoCool ST SF catheter. The study compares esophageal temperature changes during the procedure and esophageal injury detected by capsule endoscopy 2 to 4 days after ablation. During the study, esophageal temperature will be closely monitored during the ablation procedure, and capsule endoscopy will be performed afterward to assess any thermal injury. Researchers will also track complications during and immediately after the procedure. Participants will be followed for the duration of the study to evaluate these outcomes, which will help determine the impact of each ablation technique on esophageal safety.
CONDITIONS
Brief Title
Esophageal Temperature During PVI Using Q-DOT Micro
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form is provided
- Willingness to comply with all study procedures and availability for the study duration
- Male or female aged 18 years or older
- Diagnosed with paroxysmal atrial fibrillation
- Scheduled for radiofrequency catheter ablation involving circumferential point-by-point pulmonary vein isolation with no additional left atrial posterior wall ablation planned
You will not qualify if you...
- Prior left atrial ablation procedures
- Use of the Q-DOT Micro catheter in QMODE+ considered unsafe
- Contraindications to capsule endoscopy or gastrointestinal conditions increasing capsule endoscopy risks, such as esophageal strictures or inflammatory bowel disease
- Any medical records flagged as "break the glass" or "research opt out"
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo pulmonary vein isolation ablation using either the temperature-controlled very-high-power short-duration QDOT Micro catheter or the conventional high-power short-duration ThermoCool ST SF catheter. Esophageal temperature is monitored during the procedure.
1 visit (in-person)
Duration - 2 to 4 days
Participants are assessed for esophageal injury using capsule endoscopy 2 to 4 days after the ablation procedure and monitored for any procedural complications.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Cedars-Sinai Smidt Heart Institute
Los Angeles, California, United States, 90048
Actively Recruiting
Research Team
E
Eric D Braunstein, MD
T
Tansy Aguilar
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here