NCT05826665

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

October 2, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

October 16, 2024

Status Verified

October 1, 2024

Enrollment Period

1.8 years

First QC Date

April 12, 2023

Last Update Submit

October 14, 2024

Conditions

Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • To observe the acute procedural outcomes and the features of the STAR Apollo Mapping System data

    12 Months

Study Arms (1)

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.

Other: Persistent AF ablation assisted with the STAR Apollo Mapping System

Interventions

Persistent AF ablation assisted with the STAR Apollo Mapping SystemOTHER

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).

STAR Apollo Mapping System Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have been referred for persistent AF catheter ablation, who have already had AF recurrence post PVI, will be considered for this study.

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

St.Bernards Medical Center

Jonesboro, Arkansas, 72401, United States

NOT YET RECRUITING

Sarasota Medical Center

Sarasota, Florida, 34239, United States

RECRUITING

Kansas City Heart Rhythm Institute - Roe Clinic

Overland Park, Kansas, 66211, United States

NOT YET RECRUITING

Overland Park Regional Medical Center

Overland Park, Kansas, 66215, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dhanunjaya Lakkireddy, MD

    Kansas City Heart Rhythm Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Donita Atkins

CONTACT

816-651-1969datkins@kchrf.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2023

First Posted

April 24, 2023

Study Start

October 2, 2023

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

October 16, 2024

Record last verified: 2024-10

Locations

US(4)