Actively Recruiting
Observational Study to Examine the Procedural and Outcomes of AF Ablation Assisted by STAR Apollo™ Mapping System
Led by Kansas City Heart Rhythm Research Foundation · Updated on 2024-10-16
200
Participants Needed
4
Research Sites
95 weeks
Total Duration
On this page
Sponsors
K
Kansas City Heart Rhythm Research Foundation
Lead Sponsor
K
Kansas City Heart Rhythm Institute
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Observational Study to Examine the Procedural and Outcomes of AF Ablation Assisted by STAR Apollo™ Mapping System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Indication for ablation of persistent AF
- Age over 18 years
- Persistent AF lasting more than 7 days and less than 2 years
- Previous pulmonary vein isolation with AF recurrence
- Limited additional ablation at first procedure (e.g. right atrial flutter line)
You will not qualify if you...
- Previous ablation in more than one region of the left atrium besides pulmonary veins
- Longstanding persistent AF lasting more than 2 years or significant heart issues (mitral valve disease, scarring, very enlarged atria over 50mm)
- Creatinine clearance less than 30 ml/min
- Contraindication to anticoagulation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
St.Bernards Medical Center
Jonesboro, Arkansas, United States, 72401
Not Yet Recruiting
2
Sarasota Medical Center
Sarasota, Florida, United States, 34239
Actively Recruiting
3
Kansas City Heart Rhythm Institute - Roe Clinic
Overland Park, Kansas, United States, 66211
Not Yet Recruiting
4
Overland Park Regional Medical Center
Overland Park, Kansas, United States, 66215
Actively Recruiting
Research Team
D
Donita Atkins
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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