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

NCT ID: NCT04523545

Last Updated: 2022-08-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-28
• Study Completion Date: 2023-04-30

Brief Summary

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).

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Group Type: EXPERIMENTAL

cardiac ablation

Intervention Type: DEVICE

cardiac ablation using pulsed electric field energy to cause pulmonary vein isolation

Interventions

cardiac ablation

cardiac ablation using pulsed electric field energy to cause pulmonary vein isolation

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galaxy Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital of Split

Split, , Croatia

Site Status: RECRUITING

Countries

Croatia

Central Contacts

Vikramaditya Mediratta, MS

Role: CONTACT

vmediratta@galaxymedical.com

714-717-2376

James Stambaugh

Role: CONTACT

jstambaugh@galatherapeutics.com

408-718-6834

Facility Contacts

Ivan Sikiric, MD

Role: primary

ivan.sikiric20@gmail.com

38521556255

Other Identifiers

CSP-00007

Identifier Type: -

Identifier Source: org_study_id