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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation Paroxysmal
• Intervention / Treatment: Device: QDOT Micro ablation catheter; Device: ST SF ablation catheter

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric D Braunstein, MD; Phone Number: 310-248-6679; Email: Eric.Braunstein@cshs.org
• Study Contact Backup: Name: Tansy Aguilar; Email: tansy.aguilar@cshs.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Smidt Heart Institute
      • Contact: Eric D Braunstein, MD; Phone Number: 310-248-6679; Email: Eric.Braunstein@cshs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration 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 that will involve circumferential point-by-point radiofrequency ablation pulmonary vein isolation with no additional left atrial posterior wall ablation planned

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 be unsafe.
3. 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)
4. Any records flagged "break the glass" or "research opt out."

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QDOT Arm; Temperature-controlled very-high-power short-duration ablation using the QDOT Micro catheter.	Device: QDOT Micro ablation catheter; QDOT Micro ablation catheter
Active Comparator: ST SF Arm; Conventional high-power short-duration ablation using the ThermoCool ST SF catheter.	Device: ST SF ablation catheter; ST SF ablation catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximal change in esophageal temperature during posterior wall isolation.	During ablation procedure.

Secondary Outcome Measures

Outcome Measure	Time Frame
Presence of esophageal thermal injury seen on post-procedure capsule endoscopy.	2-4 days after ablation procedure.
Presence of procedural complications.	During and immediately following ablation procedure.

Other Outcome Measures

Outcome Measure	Time Frame
Number of RF ablation lesions to performed pulmonary vein isolation.	During ablation procedure.
RF time during pulmonary vein isolation.	During ablation procedure.
Left atrial dwell time to achieve pulmonary vein isolation.	During ablation procedure.
Achievement of first pass pulmonary vein isolation.	During ablation procedure.

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Collaborators: Biosense Webster, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Estimated): October 28, 2025
• Last Update Submitted That Met QC Criteria: October 26, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Esophageal thermal injury
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: STUDY00002707

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No