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

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.

Study Overview

• Status: Recruiting
• Conditions: Persistent Atrial Fibrillation
• Intervention / Treatment: Other: Persistent AF ablation assisted with the STAR Apollo Mapping System

Detailed Description

Atrial fibrillation (AF) is the most common heart rhythm abnormality. It affects 1 in 100 people. It can cause unpleasant symptoms of palpitation, shortness of breath and in some can cause heart failure or stroke. AF is triggered by abnormal electrical signals originating both in the pulmonary veins (PV), the veins that drain blood from the lungs into the heart, and in the rest of the left atrium, the heart chamber that the PVs drain into. AF can be successfully treated by a procedure called catheter ablation. This involves passing a wire up the vein at the top of the leg and delivering radiofrequency energy to the atrial tissue. This renders that tissue electrically inert. For many years this procedure has been guided by 3D cardiac mapping systems capable of showing the position of the catheters in the heart and recording their electrical signals. By doing a series of radiofrequency treatments around the mouth of the PVs it is possible to electrically isolate them so that PV signals cannot start or sustain AF. This leaves the left atrial signals untreated and limits the success of the procedure to 50%. To date clinicians have tried numerous ways to identify these remaining left atrial signals, but so far, their efforts have not improved the outcomes of ablation over just isolating the PVs alone (50% success rate). 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 AF. The STAR Apollo Mapping System system allows clinicians, after treating the PVs, 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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Donita Atkins; Phone Number: 816-651-1969; Email: Datkins@kchrf.com

Study Locations

• United States
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Not yet recruiting
      • St.Bernards Medical Center
      • Contact: Devi Nair, MD
      • Contact: Kayla Rubino; Phone Number: 870-9356-729; Email: krubino@dnairresearch.com
  • Florida
    • Sarasota, Florida, United States, 34239
      • Recruiting
      • Sarasota Medical Center
      • Contact: Colleen Lindner; Email: colleen-lindner@smh.com
      • Contact: Dilip Matthew, MD
  • Kansas
    • Overland Park, Kansas, United States, 66215
      • Recruiting
      • Overland Park Regional Medical Center
      • Contact: Donita Atkins
    • Overland Park, Kansas, United States, 66211
      • Not yet recruiting
      • Kansas City Heart Rhythm Institute - Roe Clinic
      • Contact: Dhanunjaya Lakkireddy, MD; Phone Number: 913-449-1297; Email: dlakkireddy@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To observe the acute procedural outcomes and the features of the STAR Apollo Mapping System data	The secondary objective is to observe the acute procedural outcomes and the features of the STAR Apollo Mapping System data and the physician's treatment plan that may influence outcomes.	12 Months

Collaborators and Investigators

• Sponsor: Kansas City Heart Rhythm Research Foundation
• Collaborators: Kansas City Heart Rhythm Institute; St. Bernards Medical Center; Sarasota Medical Center
• Investigators: Principal Investigator: Dhanunjaya Lakkireddy, MD, Kansas City Heart Rhythm Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: April 12, 2023
• First Submitted That Met QC Criteria: April 12, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 13, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: KCHRRF_Star Apollo_0018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No