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NCT Number: NCT06392932

Esophageal Temperature During PVI Using Q-DOT Micro

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Smidt Heart Institute

Los Angeles, California, 90048, United States

Location status: Recruiting

Location contact

Eric D Braunstein, MD

CONTACT

[email protected]

310-248-6679

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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."

Treatment and study plan

QDOT Micro ablation catheter

Device

QDOT Micro ablation catheter

ST SF ablation catheter

Device

ST SF ablation catheter

Primary outcomes

  1. Maximal change in esophageal temperature during posterior wall isolation.

    Time frame: During ablation procedure.

Secondary outcomes

  1. Presence of esophageal thermal injury seen on post-procedure capsule endoscopy.

    Time frame: 2-4 days after ablation procedure.

  2. Presence of procedural complications.

    Time frame: During and immediately following ablation procedure.

Other outcomes

  1. Number of RF ablation lesions to performed pulmonary vein isolation.

    Time frame: During ablation procedure.

  2. RF time during pulmonary vein isolation.

    Time frame: During ablation procedure.

  3. Left atrial dwell time to achieve pulmonary vein isolation.

    Time frame: During ablation procedure.

  4. Achievement of first pass pulmonary vein isolation.

    Time frame: During ablation procedure.

Study contacts

Contact information is provided by the study sponsor or research team.

Eric D Braunstein, MD

CONTACT

[email protected]

310-248-6679

Tansy Aguilar

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Collaborators

  • Biosense Webster, Inc.

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 1, 2024
Registry last updated
Oct 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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