Esophageal Temperature During PVI Using Q-DOT Micro

NCT ID: NCT06392932

Last Updated: 2025-10-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-04
• Study Completion Date: 2027-03-31

Brief 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.

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.

Conditions

Atrial Fibrillation Paroxysmal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

QDOT Arm

Temperature-controlled very-high-power short-duration ablation using the QDOT Micro catheter.

Group Type: EXPERIMENTAL

QDOT Micro ablation catheter

Intervention Type: DEVICE

QDOT Micro ablation catheter

ST SF Arm

Conventional high-power short-duration ablation using the ThermoCool ST SF catheter.

Group Type: ACTIVE_COMPARATOR

ST SF ablation catheter

Intervention Type: DEVICE

ST SF ablation catheter

Interventions

QDOT Micro ablation catheter

QDOT Micro ablation catheter

Intervention Type: DEVICE

ST SF ablation catheter

ST SF ablation catheter

Intervention Type: DEVICE

Eligibility Criteria

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."

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: collaborator

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Eric Braunstein

Staff Physician I

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cedars-Sinai Smidt Heart Institute

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Eric D Braunstein, MD

Role: CONTACT

Eric.Braunstein@cshs.org

310-248-6679

Tansy Aguilar

Role: CONTACT

tansy.aguilar@cshs.org

Facility Contacts

Eric D Braunstein, MD

Role: primary

Eric.Braunstein@cshs.org

310-248-6679

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STUDY00002707

Identifier Type: -

Identifier Source: org_study_id