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Procedure

Unipolar Polarity Switch for Atrial Fibrillation

N/A
Recruiting
Led By Dhanunjaya Lakkireddy
Research Sponsored by Kansas City Heart Rhythm Research Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing pulmonary vein isolation for De-Novo Atrial Fibrillation.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial showed that a new technique for measuring lesion effectiveness during ablation procedures led to shorter procedures, less radiation exposure, and better outcomes.

Who is the study for?
This trial is for adults (18+) who are undergoing their first pulmonary vein isolation procedure to treat new-onset Atrial Fibrillation. It's not open to those who can't consent or don't have this specific type of heart rhythm disorder.Check my eligibility
What is being tested?
The study tests a technique using Unipolar Polarity Switch on the left and right sides during the procedure, aiming to improve outcomes by assessing lesion effectiveness more accurately, which may reduce time and radiation exposure.See study design
What are the potential side effects?
While specific side effects aren't listed, procedures involving pulmonary vein isolation can include risks such as bleeding, infection at the catheter site, damage to blood vessels or heart structures, arrhythmias, or reactions from anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a procedure to treat new onset atrial fibrillation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy rate of loss of unipolar negative component
Esophageal "Time above threshold"
Esophageal "Time to return to baseline"
+9 more
Secondary outcome measures
6-month freedom from AF
Compare 1st pass isolation
Discrimination with High Frequency Algorithm as a confirmation tool
+4 more

Trial Design

2Treatment groups
Active Control
Group I: Unipolar Polarity Switch Left and CAI-OPR-LAAP RightActive Control1 Intervention
Group II: CAI-OPR-LAAP Left and Unipolar Polarity Switch RightActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Kansas City Heart Rhythm Research FoundationLead Sponsor
26 Previous Clinical Trials
11,942 Total Patients Enrolled
13 Trials studying Atrial Fibrillation
4,278 Patients Enrolled for Atrial Fibrillation
Kansas City Heart Rhythm Institute, Overland Park, KSUNKNOWN
1 Previous Clinical Trials
100 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
100 Patients Enrolled for Atrial Fibrillation
Dhanunjaya LakkireddyPrincipal InvestigatorKansas City Heart Rhythm Institute
11 Previous Clinical Trials
9,056 Total Patients Enrolled
6 Trials studying Atrial Fibrillation
3,196 Patients Enrolled for Atrial Fibrillation

Media Library

Unipolar Polarity Switch Left (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05464537 — N/A
Atrial Fibrillation Research Study Groups: Unipolar Polarity Switch Left and CAI-OPR-LAAP Right, CAI-OPR-LAAP Left and Unipolar Polarity Switch Right
Atrial Fibrillation Clinical Trial 2023: Unipolar Polarity Switch Left Highlights & Side Effects. Trial Name: NCT05464537 — N/A
Unipolar Polarity Switch Left (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05464537 — N/A
~12 spots leftby Dec 2024
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