NCT05826665|RecruitingFDA Device
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Sponsor study identifier
observational
200
1 country
4
Study Start
October 2, 2023
Actual (reported)Primary Completion
July 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 12, 2023
Actual (reported)April 24, 2023
Actual (reported)October 2, 2023
Actual (reported)July 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
To determine the impact of STAR Apollo Mapping System on the procedural parameters of persistent AF ablation
The primary objective for the study is to determine the impact of STAR Apollo Mapping System on the procedural parameters of persistent AF ablation. These include procedure duration and the number of radiofrequency (RF) lesions applied post PVI.
12 Months
To observe the acute procedural outcomes and the features of the STAR Apollo Mapping System data
12 Months
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.
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients who have been referred for persistent AF catheter ablation, who have already had AF recurrence post PVI, will be considered for this study.
St.Bernards Medical Center
Jonesboro, Arkansas, 72401, United States
Sarasota Medical Center
Sarasota, Florida, 34239, United States
Kabra R, McKillop M, Vora A, Oza S, Nair DG, Mathew D, Darden D, Lakkireddy DR; STAR Apollo Study Investigators. Map-guided redo ablation for recurrent persistent atrial fibrillation after prior pulmonary vein isolation: Procedural feasibility, safety, and 12-month rhythm outcomes from a prospective multicenter study (NCT05826665). Heart Rhythm. 2026 Sep 20:S1547-5271(26)02767-0. doi: 10.1016/j.hrthm.2026.09.004. Online ahead of print.
Dhanunjaya Lakkireddy, MD
Kansas City Heart Rhythm Institute
First Submitted
April 12, 2023
First Posted
April 24, 2023
Study Start
October 2, 2023
Actual (reported)Primary Completion
July 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
PVI Alone Versus PVI Plus PWI and SVCI With PFA
Contact the study team to confirm eligibility.
Kansas City Heart Rhythm Institute - Roe Clinic
Overland Park, Kansas, 66211, United States
Overland Park Regional Medical Center
Overland Park, Kansas, 66215, United States
Study Completion
July 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 16, 2024
Record last verified: 2024-10
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Source: ClinicalTrials.gov.
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