← Back to Search

Procedure

QDOT Arm for Atrial Fibrillation

N/A

Recruiting

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during ablation procedure.

Awards & highlights

Study Summary

"This trial will compare two methods of using ablation catheters during a procedure for paroxysmal atrial fibrillation to see how they affect the temperature of the esophagus and the risk of

Who is the study for?

This trial is for individuals with paroxysmal atrial fibrillation, a type of irregular heart rhythm. Participants should be eligible for catheter ablation, a procedure to correct the heart rhythm. Specific eligibility criteria are not provided but would typically include age range, overall health status, and absence of conditions that could complicate the procedure.Check my eligibility

What is being tested?

The study is testing two different types of ablation catheters: ST SF and QDOT Micro. It aims to compare how each affects esophageal temperature during use in catheter ablation procedures and their risk of causing esophageal injury.See study design

What are the potential side effects?

While specific side effects are not listed, typical risks associated with ablation procedures may include discomfort at the catheter insertion site, bleeding or infection risks from invasive procedures, potential damage to surrounding tissues or organs like the esophagus.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with occasional irregular heartbeats.

Select...

I am scheduled for a specific heart rhythm correction procedure for my irregular heartbeat.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during ablation procedure.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during ablation procedure.

This trial's timeline: 3 weeks for screening, Varies for treatment, and during ablation procedure. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximal change in esophageal temperature during posterior wall isolation.

Secondary outcome measures

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

Presence of procedural complications.

Other outcome measures

Achievement of first pass pulmonary vein isolation.

Left atrial dwell time to achieve pulmonary vein isolation.

Number of RF ablation lesions to performed pulmonary vein isolation.

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: QDOT ArmExperimental Treatment1 Intervention

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

Group II: ST SF ArmActive Control1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor

502 Previous Clinical Trials

165,663 Total Patients Enrolled

2 Trials studying Atrial Fibrillation

430 Patients Enrolled for Atrial Fibrillation

Biosense Webster, Inc.Industry Sponsor

123 Previous Clinical Trials

36,587 Total Patients Enrolled

82 Trials studying Atrial Fibrillation

28,504 Patients Enrolled for Atrial Fibrillation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit for the number of participants involved in this study?

"Indeed, as per clinicaltrials.gov, this trial is actively searching for eligible participants. It was first listed on June 1st, 2024 and most recently revised on April 29th of the same year. The study aims to enroll a total of 30 individuals across a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Esophageal Temperature During PVI Using Q-DOT Micro

Eric Braunstein 2024. "Esophageal Temperature During PVI Using Q-DOT Micro". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06392932.

All > Anaheim > Paid Studies Ventura