An interventional study of QDOT Micro ablation catheter and ST SF ablation catheter in Atrial Fibrillation Paroxysmal, sponsored by Cedars-Sinai Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-28.
Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Treatment
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.
This is a prospective randomized controlled trial, studying patients undergoing ablation involving pulmonary vein isolation for paroxysmal atrial fibrillation. Patients will be assigned to undergo conventional high-power short-duration ablation or temperature-controlled very-high-power short-duration ablation, and esophageal outcomes including temperature changes during ablation and esophageal injury as assessed by post-procedure capsule endoscopy will be compared between the groups. The hypothesis is that very-high-power short-duration ablation will lead to lower rises in esophageal temperature and lower rates of esophageal findings during capsule endoscopy.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 30 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Temperature-controlled very-high-power short-duration ablation using the QDOT Micro catheter.
Device: QDOT Micro ablation catheter
Conventional high-power short-duration ablation using the ThermoCool ST SF catheter.
Device: ST SF ablation catheter
QDOT Micro ablation catheter
ST SF ablation catheter
Maximal change in esophageal temperature during posterior wall isolation.
Time frame: During ablation procedure.
Presence of esophageal thermal injury seen on post-procedure capsule endoscopy.
Time frame: 2-4 days after ablation procedure.
Presence of procedural complications.
Time frame: During and immediately following ablation procedure.
Number of RF ablation lesions to performed pulmonary vein isolation.
Time frame: During ablation procedure.
RF time during pulmonary vein isolation.
Time frame: During ablation procedure.
Left atrial dwell time to achieve pulmonary vein isolation.
Time frame: During ablation procedure.
Achievement of first pass pulmonary vein isolation.
Time frame: During ablation procedure.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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Cedars-Sinai Medical Center