Observational Study to Examine the Procedural and Outcomes of AF Ablation Assisted by STAR Apollo™ Mapping System
Recruiting · NCT05826665 · Observational (researchers observe without assigning treatment) · Lead sponsor: Kansas City Heart Rhythm Research Foundation
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
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
Where it is running
4 locations listed across 3 US states.
- 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