Atrial Fibrillation
Conditions
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).
Interventions
DEVICEcardiac ablation
cardiac ablation using pulsed electric field energy to cause pulmonary vein isolation
Sponsors
Galaxy Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of device and procedure related serious adverse events | 30 days | The rate of system-related and procedure-related serious adverse events (SAEs) |
| Acute Procedural Success | During treatment procedure | Proportion of patients with confirmed pulmonary vein isolation (PVI) during the index procedure |
| Chronic Feasibility: Proportion of patients with documented electrical isolation of the pulmonary veins | 90 days | Proportion of patients with documented electrical isolation of the pulmonary veins |
Countries
Croatia
Contacts
Primary ContactVikramaditya Mediratta, MS
Backup ContactJames Stambaugh
Outcome results
None listed