Clinical trial NCT04652778: Safety & Performance of the Centauri System for Patients With Atrial Fibrillation
Official title: Safety & Performance of Ablation With the Centauri System for the Elimination of Atrial Fibrillation (SPACE AF)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Galaxy Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-03
Enrollment: 15
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 is a prospective, single-arm, open-label clinical 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 will include 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), and PVI - with or without additional left atrial ablations - in patients with Persistent AF (PeAF) of short duration (\< 1 year).


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. Age 18 through 75 years-old on the day of enrollment
4. Patient is indicated for an ablation procedure according to society guidelines or investigational site practice
5. Patient is willing and able to give informed consent.
6. Patient is willing, able, and committed to participate in baseline and follow-up evaluations for the full 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. Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the index ablation procedure
5. Use of amiodarone within 6 weeks prior to enrollment
6. Prior left atrial ablation or surgical procedure (including left atrial appendage (LAA) device or occlusion)
7. 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
8. 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)
9. Presence of any pulmonary vein stents
10. Presence of any pre-existing pulmonary vein stenosis
11. Pre-existing hemidiaphragmatic paralysis
12. Atrial or ventricular septal defect closure
13. Atrial myxoma
14. Presence of any prosthetic heart valve
15. Hemodynamically significant valvular disease
16. History of pericarditis
17. History of Rheumatic heart disease
18. History of thromboembolic event within 6 months of time of enrollment or evidence of intracardiac thrombus at time of procedure
19. 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))

Primary outcomes:
measure: Device and Procedure related serious adverse event rate
timeFrame: 30 days
measure: Acute Procedural Success
timeFrame: During treatment procedure
measure: Chronic Success
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
Study officials:
References: