Recruiting

Q-DOT Micro

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT06392932

Conditions

Atrial Fibrillation Paroxysmal

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

QDOT Micro ablation catheter

ST SF ablation catheter

Study Details

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.

Conditions

Atrial Fibrillation Paroxysmal

Study ID

NCT06392932

Start date

Oct 4, 2024

Status verified date

Oct, 2025

Completion date

Mar, 2027

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: QDOT Arm

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

active comparator: ST SF Arm

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

Interventions

QDOT Micro ablation catheter

QDOT Micro ablation catheter

ST SF ablation catheter

ST SF ablation catheter

Primary outcome measure

  • Maximal change in esophageal temperature during posterior wall isolation. [ Time Frame: During ablation procedure. ]

Central Contacts and Locations

Central contacts

Locations

Cedars-Sinai Smidt Heart Institute

Recruiting

Los Angeles, California, United States, 90048

Contacts

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Oct 28, 2025

Last verified

Oct, 2025

Keywords

  • Atrial Fibrillation
  • Esophageal thermal injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2025-10-28.