Observational Study to Examine the Procedural and Outcomes of AF Ablation Assisted by STAR Apollo™ Mapping System
Kansas City Heart Rhythm Research Foundation
200 participants
Oct 2, 2023
OBSERVATIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria4
- 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
Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT05826665