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Observational Study to Examine the Procedural and Outcomes of AF Ablation Assisted by STAR Apollo™ Mapping System

RECRUITINGSponsored by Kansas City Heart Rhythm Research Foundation
Actively Recruiting
SponsorKansas City Heart Rhythm Research Foundation
Started2023-10-02
Est. completion2025-07-31
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
Locations4 sites

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

Age: 18 Years – 80 YearsHealthy volunteers accepted
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

Conditions2

Heart DiseasePersistent Atrial Fibrillation

Locations4 sites

Arkansas

1 site
St.Bernards Medical Center
Jonesboro, Arkansas, 72401
Devi Nair, MD

Florida

1 site
Sarasota Medical Center
Sarasota, Florida, 34239
Dilip Matthew, MD

Kansas

2 sites
Kansas City Heart Rhythm Institute - Roe Clinic
Overland Park, Kansas, 66211
Dhanunjaya Lakkireddy, MD913-449-1297dlakkireddy@gmail.com
Overland Park Regional Medical Center
Overland Park, Kansas, 66215
Donita Atkins

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