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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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). Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 Criteria: * 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

Treatments Being Tested

OTHER

Persistent 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).

Locations (4)

St.Bernards Medical Center
Jonesboro, Arkansas, United States
Sarasota Medical Center
Sarasota, Florida, United States
Kansas City Heart Rhythm Institute - Roe Clinic
Overland Park, Kansas, United States
Overland Park Regional Medical Center
Overland Park, Kansas, United States