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

Description

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

Persistent Atrial Fibrillation

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Persistent Atrial Fibrillation
Intervention / Treatment

-

Contacts and Locations

Jonesboro

St.Bernards Medical Center, Jonesboro, Arkansas, United States, 72401

Sarasota

Sarasota Medical Center, Sarasota, Florida, United States, 34239

Overland Park

Kansas City Heart Rhythm Institute - Roe Clinic, Overland Park, Kansas, United States, 66211

Overland Park

Overland Park Regional Medical Center, Overland Park, Kansas, United States, 66215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kansas City Heart Rhythm Research Foundation,

Dhanunjaya Lakkireddy, MD, PRINCIPAL_INVESTIGATOR, Kansas City Heart Rhythm Institute

Study Record Dates

2025-07-31