Safety & Clinical Performance Study of Catheter Ablation With the Centauri System for Patients With Atrial Fibrillation (ECLIPSE AF)

Safety & Performance Study of the Centauri System for Patients With Atrial Fibrillation

This study is a prospective, single-arm, open-label study following patients to 1 year, to evaluate the safety and performance of the Centauri System for catheter ablation of atrial fibrillation (AF). The study is intended for adult patients (age 18-75 years) who are indicated for a first-time catheter ablation of AF where the pre-procedure treatment plan contemplates pulmonary vein isolation (PVI) in patients with paroxysmal AF (PAF) or short-duration (<1 year) persistent AF (PeAF).

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: cardiac ablation

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vikramaditya Mediratta, MS; Phone Number: 714-717-2376; Email: vmediratta@galaxymedical.com
• Study Contact Backup: Name: James Stambaugh; Phone Number: 408-718-6834; Email: jstambaugh@galatherapeutics.com

Study Locations

• Croatia
  • Split, Croatia, 21000
    • Recruiting
    • University Hospital of Split
    • Contact: Ivan Sikiric, MD; Phone Number: 38521556255; Email: ivan.sikiric20@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Failure of at least one antiarrhythmic drug (AAD) (Class I - IV) for AF, as evidenced by recurrent symptomatic AF or intolerable side effects due to AAD

2. Diagnosis of recurrent symptomatic paroxysmal AF (PAF) or short duration (< 1 year) Persistent AF (PeAF) with the following documentation:

   a. PAF i. Physician's note indicating symptoms consistent with recurrent symptomatic PAF AND ii. ≥ 2 episodes of PAF within 12 months prior to enrollment. At least one episode should be documented by ECG, transtelephonic monitor (TTM), Holter monitor, telemetry strip or similar, showing at least 30 seconds of AF b. PeAF i. Physician's note indicating symptoms consistent with continuous AF episode lasting longer than 7 days but less than 1 year AND ii. Any 24-hour continuous ECG recording documenting persistent AF within 6 months prior to enrollment OR iii. Two ECGs from any form of rhythm monitoring showing continuous AF taken at least 7 days apart within 12 months prior to enrollment OR iv. History of direct current cardioversion (DCCV) performed within 12 months prior to enrollment

3. Patient is indicated for an ablation procedure according to society guidelines or investigational site practice
4. Patient is willing and able to give informed consent.
5. Patient is willing, able and committed to participate in baseline and follow-up evaluations for the duration of the study.

Exclusion Criteria:

1. Long-standing persistent AF (continuous AF sustained > 1 year)
2. AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other reversible/non-cardiac causes
3. Left atrial anteroposterior diameter > 5.0 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT) within 6 months prior to enrollment
4. Use of amiodarone within 6 weeks prior to enrollment
5. Prior left atrial ablation or surgical procedure (including left atrial appendage (LAA) device or occlusion)
6. Planned LAA closure procedure or implant of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during the follow-up period
7. Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
8. Presence of any pulmonary vein stents
9. Presence of any pre-existing pulmonary vein stenosis
10. Pre-existing hemidiaphragmatic paralysis
11. Atrial or ventricular septal defect closure
12. Atrial myxoma
13. Presence of any prosthetic heart valve
14. Hemodynamically significant valvular disease
15. History of pericarditis
16. History of Rheumatic heart disease
17. History of thromboembolic event within 6 months of time of enrollment or evidence of intracardiac thrombus at time of procedure

18. Any of the following events within 3 months of enrollment

    • Myocardial infarction (MI)
    • Unstable angina
    • Percutaneous coronary intervention
    • Heart surgery including coronary artery bypass grafting
    • Heart failure hospitalization
    • Cerebral ischemic event (stroke or transient ischemic attack (TIA))
    • Clinically significant bleeding
    • Pericardial effusion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment	Device: cardiac ablation; cardiac ablation using pulsed electric field energy to cause pulmonary vein isolation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Procedural Success	Proportion of patients with confirmed pulmonary vein isolation (PVI) during the index procedure	During treatment procedure
Rate of device and procedure related serious adverse events	The rate of system-related and procedure-related serious adverse events (SAEs)	30 days
Chronic Feasibility: Proportion of patients with documented electrical isolation of the pulmonary veins	Proportion of patients with documented electrical isolation of the pulmonary veins	90 days

Collaborators and Investigators

• Sponsor: Galaxy Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2020
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Actual): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 18, 2022
• Last Verified: August 1, 2022

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: CSP-00007

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.: Yes