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

Part of paid clinical trials in Jonesboro, Arkansas.

Sponsor
Kansas City Heart Rhythm Research Foundation
Study ID
NCT05826665
Status
Recruiting
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Conditions

  • Persistent Atrial Fibrillation

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Persistent AF ablation assisted with the STAR Apollo Mapping System — OTHER
    This exploratory hypothesis generating data set will be collected during standard AF ablation procedures using FDA cleared technologies as described in their Instructions for Use (IFU). No randomization or experimental protocols will be used during this study, and all follow up will be performed as per the center's standard of care(SOC).

Study Details

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 Dates

Start date
Oct 2, 2023
Status verified
Oct 2024
Primary completion
Jul 31, 2025
Completion
Jul 31, 2025

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: STAR Apollo Mapping System Group
    Patients who have been referred for persistent AF catheter ablation, who have already had AF recurrence post Pulmonary Vein Isolation (PVI), will be considered for this study.

Primary Outcome Measure

To determine the impact of STAR Apollo Mapping System on the procedural parameters of persistent AF ablation [ Time Frame: 12 Months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
St.Bernards Medical CenterJonesboroArkansas72401
Devi Nair, MD
Kayla Rubino
[email protected]
870-9356-729
Sarasota Medical CenterSarasotaFlorida34239
Dilip Matthew, MD
Colleen Lindner
[email protected]
Kansas City Heart Rhythm Institute - Roe ClinicOverland ParkKansas66211
Dhanunjaya Lakkireddy, MD
[email protected]
913-449-1297
Overland Park Regional Medical CenterOverland ParkKansas66215
Donita Atkins

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St.Bernards Medical Center· Jonesboro, ARSarasota Medical Center· Sarasota, FLKansas City Heart Rhythm Institute - Roe Clinic· Overland Park, KSOverland Park Regional Medical Center· Overland Park, KS

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