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.
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 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
Patients who have been referred for persistent AF catheter ablation, who have already had AF recurrence post PVI, will be considered for this study.
Cohort
Prospective
Persistent AF ablation assisted with the STAR Apollo Mapping System
Other interventionThis 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).
To determine the impact of STAR Apollo Mapping System on the procedural parameters of persistent AF ablation
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.
To observe the acute procedural outcomes and the features of the STAR Apollo Mapping System data
The secondary objective is to observe the acute procedural outcomes and the features of the STAR Apollo Mapping System data and the physician's treatment plan that may influence outcomes.
Click on the lead sponsor to view all of their trials.
Kansas City Heart Rhythm Research Foundation
Lead sponsor
Kansas City Heart Rhythm Institute
Collaborator
St. Bernards Medical Center
Collaborator
Sarasota Medical Center
Collaborator
