Observational Study of STAR Apollo™ Mapping System for Persistent Atrial Fibrillation

This study is looking at how the STAR Apollo Mapping System helps doctors perform a procedure called ablation for persistent atrial fibrillation (AF). AF is a common heart rhythm problem. The STAR Apollo Mapping System is a tool that helps doctors understand the electrical signals in your heart during the ablation procedure. This study will observe 200 people between 18 and 80 years old who have persistent AF and have already had a previous ablation that didn't fully work. The main goal is to see how this system affects the procedure itself and its immediate results. This is an observational study, meaning doctors will use the system as part of their standard care, and no experimental treatments are involved. The study is currently recruiting participants.

Study design
This is an observational study involving 200 participants. It is not a randomized study, and no specific phase is mentioned.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The impact of the STAR Apollo Mapping System on procedural parameters will be measured at 12 months.

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NCT05826665

Observational Study to Examine the Procedural and Outcomes of AF Ablation Assisted by STAR Apollo™ Mapping System

Recruiting
Not specifiedAges 18–80Observational
Kansas City Heart Rhythm Research Foundation
~200 participants
Updated 2024-10-16 on ClinicalTrials.gov
What's tested:Persistent AF ablation assisted with the STAR Apollo Mapping System

At a glance

Recruiting sites
2 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To determine the impact of STAR Apollo Mapping System on the procedural parameters of persistent AF ablation
Measured over 12 Months
Persistent Atrial Fibrillation

NCT05826665

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Kansas City Heart Rhythm Institute - Roe Clinic

    Overland Park, Kansasstudy coordinator listed

    Not yet recruiting

  • Sarasota Medical Center

    Sarasota, Floridastudy coordinator listed

    Recruiting

  • St.Bernards Medical Center

    Jonesboro, Arkansasstudy coordinator listed

    Not yet recruiting

  • Overland Park Regional Medical Center

    Overland Park, Kansasno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Dhanunjaya Lakkireddy, MD · PRINCIPAL_INVESTIGATOR · Kansas City Heart Rhythm Institute

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Eligibility criteria

Inclusion

Indication for ablation of persistent AF
Age \>18 years
Persistent AF \>7 days and total continuous duration \<2 years
Patients have previously undergone pulmonary vein isolation, using any technique and have had AF recurrence.
Patients have limited additional ablation at their first procedure (e.g. right atrial flutter line).

Exclusion

Patients with previous ablation in more than one region of the left atrium in addition to the pulmonary veins.
Patients with longstanding persistent AF (continuous duration \>2 years) or significant substrate (mitral valve disease, scarring, very dilated atria \>50mm).
Creatinine clearance estimated glomerular filtration rate (eGFR) \<30mls/min
Contraindication to anticoagulation
  • To determine the impact of STAR Apollo Mapping System on the procedural parameters of persistent AF ablation12 Months

    The primary objective for the study is to determine the impact of STAR Apollo Mapping System on the procedural parameters of persistent AF ablation. These include procedure duration and the number of radiofrequency (RF) lesions applied post PVI.