Esophageal Temperature During PVI Using Q-DOT Micro

Last updated: October 4, 2024
Sponsor: Cedars-Sinai Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Arrhythmia

Atrial Fibrillation

Treatment

QDOT Micro ablation catheter

ST SF ablation catheter

Clinical Study ID

NCT06392932
STUDY00002707
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Provision of signed and dated informed consent form

  2. Stated willingness to comply with all study procedures and availability for theduration of the study

  3. Male or female, aged greater than or equal to 18 years

  4. Diagnosed with paroxysmal atrial fibrillation

  5. Undergoing RF catheter ablation for treatment of paroxysmal atrial fibrillation thatwill involve circumferential point-by-point radiofrequency ablation pulmonary veinisolation with no additional left atrial posterior wall ablation planned

Exclusion

Exclusion Criteria:

  1. Patients who have undergone prior left atrial ablation procedures.

  2. 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 beunsafe.

  3. Patients who have contraindications to capsule endoscopy, or GI conditions that mayincrease the risks of capsule endoscopy (e.g. esophageal strictures, inflammatorybowel disease, etc)

  4. Any records flagged "break the glass" or "research opt out."

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: QDOT Micro ablation catheter
Phase:
Study Start date:
October 04, 2024
Estimated Completion Date:
March 31, 2026

Study Description

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.

Connect with a study center

  • Cedars-Sinai Smidt Heart Institute

    Los Angeles, California 90048
    United States

    Active - Recruiting

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