Recruiting

AF Ablation

Sponsor:

Kansas City Heart Rhythm Research Foundation

Code:

NCT05826665

Conditions

Persistent Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Persistent AF ablation assisted with the STAR Apollo Mapping System

Study Details

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.

Conditions

Persistent Atrial Fibrillation

Study ID

NCT05826665

Start date

Oct 2, 2023

Status verified date

Oct, 2024

Completion date

Jul 31, 2025

Anticipated

Primary completion date

Jul 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion 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).

Exclusion Criteria:

  • 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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Persistent AF ablation assisted with the STAR Apollo Mapping System

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).

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 and Locations

Central contacts

Donita Atkins

816-651-1969datkins@kchrf.com

Locations

Sarasota Medical Center

Recruiting

Sarasota, Florida, United States, 34239

Contacts

Colleen Lindner

colleen-lindner@smh.com

Overland Park Regional Medical Center

Recruiting

Overland Park, Kansas, United States, 66215

More Information

Sponsor

Kansas City Heart Rhythm Research Foundation

Last update posted

Oct 16, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kansas City Heart Rhythm Research Foundation on 2024-10-16.