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)

Cedars-Sinai Smidt Heart Institute

Los Angeles, California, United States

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NCT06392932


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