Clinical trial NCT04523545: Safety & Clinical Performance Study of Catheter Ablation With the Centauri System for Patients With Atrial Fibrillation
Official title: Safety & Performance Study of the Centauri System for Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Galaxy Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Rate of device and procedure related serious adverse events
timeFrame: 30 days
measure: Acute Procedural Success
timeFrame: During treatment procedure
measure: Chronic Feasibility: Proportion of patients with documented electrical isolation of the pulmonary veins
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Split
country: Croatia
facility: University Hospital of Split
Study officials:
References: