RecruitingNCT05826665

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

Sponsor

Kansas City Heart Rhythm Research Foundation

Enrollment

200 participants

Start Date

Oct 2, 2023

Study Type

OBSERVATIONAL

Conditions

Persistent Atrial Fibrillation

Summary

STAR Apollo Mapping System is an FDA cleared mapping technology that can analyze the signals collected during the ablation procedure on the 3D mapping system and give the physician further insight into the AF activation patterns which may assist them in identifying areas responsible for maintaining Atrial Fibrillation (AF). The STAR Apollo Mapping System system allows clinicians, after treating the Pulmonary Veins (PV), to collect data from the atria during clinical AF procedures using standard FDA cleared catheters and devices. This study aims to examine the impact of the STAR Apollo Mapping System on procedural and acute outcomes in a multicenter observational study.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This observational study is examining how a new heart mapping technology called STAR Apollo is used during ablation procedures (a treatment that uses heat to destroy abnormal heart tissue) for people with persistent atrial fibrillation (an irregular heartbeat) that has returned after a first procedure. **You may be eligible if...** - You are over 18 years old - You have persistent atrial fibrillation that has lasted more than 7 days but less than 2 years - You have already had a pulmonary vein isolation procedure (a standard ablation for AF) and your AF has come back - You are scheduled for a repeat ablation procedure **You may NOT be eligible if...** - You have had extensive previous ablation in multiple areas of the heart beyond the pulmonary veins - Your atrial fibrillation has been continuous for more than 2 years, or you have significant structural heart disease (e.g., severe mitral valve disease or a significantly enlarged heart) - Your kidney function is significantly reduced - You cannot safely take blood thinners Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPersistent AF ablation assisted with the STAR Apollo Mapping System

This exploratory hypothesis generating data set will be collected during standard AF ablation procedures using FDA cleared technologies as described in their Instructions for Use (IFU). No randomization or experimental protocols will be used during this study, and all follow up will be performed as per the center's standard of care(SOC).