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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorKansas City Heart Rhythm Research Foundation

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Persistent AF ablation assisted with the STAR Apollo Mapping System

Treatment groups

200 Participants
are divided into 1 treatment group

Sponsors and collaborators

Kansas City Heart Rhythm Research Foundation

Lead sponsor

Kansas City Heart Rhythm Institute

Collaborator

St. Bernards Medical Center

Collaborator

Sarasota Medical Center

Collaborator