Observational Study to Examine the Procedural and Outcomes of AF Ablation Assisted by STAR Apollo™ Mapping System
Recruiting now
Conditions studied: Persistent Atrial Fibrillation
In brief
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.
Key facts
- Study ID
- NCT05826665
- Run by
- Kansas City Heart Rhythm Research Foundation
- People needed
- 200
- Starts
- 2023-10-02
- Expected to finish
- 2025-07-31
- Last updated by the study team
- 2024-10-16
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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
- Sarasota Medical Center — Sarasota, Florida, United States (enrolling)
- Overland Park Regional Medical Center — Overland Park, Kansas, United States (enrolling)
- St.Bernards Medical Center — Jonesboro, Arkansas, United States
- Kansas City Heart Rhythm Institute - Roe Clinic — Overland Park, Kansas, United States
Full record on ClinicalTrials.gov
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