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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Cedars-Sinai Smidt Heart Institute
RECRUITING
Los Angeles
Contact Information
Primary
Eric D Braunstein, MD
Eric.Braunstein@cshs.org
310-248-6679
Backup
Tansy Aguilar
tansy.aguilar@cshs.org
Time Frame
Start Date: 2024-10-04
Estimated Completion Date: 2027-03
Participants
Target number of participants: 30
Treatments
Experimental: QDOT Arm
Temperature-controlled very-high-power short-duration ablation using the QDOT Micro catheter.
Active_comparator: ST SF Arm
Conventional high-power short-duration ablation using the ThermoCool ST SF catheter.
Related Therapeutic Areas
Sponsors
Collaborators: Biosense Webster, Inc.
Leads: Cedars-Sinai Medical Center

This content was sourced from clinicaltrials.gov