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

Primary Purpose

Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
cardiac ablation
Sponsored by
Galaxy Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of SplitRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Outcomes

Primary Outcome Measures

Rate of device and procedure related serious adverse events
The rate of system-related and procedure-related serious adverse events (SAEs)
Acute Procedural Success
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
Proportion of patients with documented electrical isolation of the pulmonary veins

Secondary Outcome Measures

Full Information

First Posted
August 19, 2020
Last Updated
August 18, 2022
Sponsor
Galaxy Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04523545
Brief Title
Safety & Clinical Performance Study of Catheter Ablation With the Centauri System for Patients With Atrial Fibrillation
Acronym
ECLIPSE AF
Official Title
Safety & Performance Study of the Centauri System for Patients With Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2020 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galaxy Medical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
cardiac ablation
Intervention Description
cardiac ablation using pulsed electric field energy to cause pulmonary vein isolation
Primary Outcome Measure Information:
Title
Rate of device and procedure related serious adverse events
Description
The rate of system-related and procedure-related serious adverse events (SAEs)
Time Frame
30 days
Title
Acute Procedural Success
Description
Proportion of patients with confirmed pulmonary vein isolation (PVI) during the index procedure
Time Frame
During treatment procedure
Title
Chronic Feasibility: Proportion of patients with documented electrical isolation of the pulmonary veins
Description
Proportion of patients with documented electrical isolation of the pulmonary veins
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Patient is indicated for an ablation procedure according to society guidelines or investigational site practice Patient is willing and able to give informed consent. Patient is willing, able and committed to participate in baseline and follow-up evaluations for the duration of the study. Exclusion Criteria: Long-standing persistent AF (continuous AF sustained > 1 year) AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other reversible/non-cardiac causes Left atrial anteroposterior diameter > 5.0 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT) within 6 months prior to enrollment Use of amiodarone within 6 weeks prior to enrollment Prior left atrial ablation or surgical procedure (including left atrial appendage (LAA) device or occlusion) 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 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) Presence of any pulmonary vein stents Presence of any pre-existing pulmonary vein stenosis Pre-existing hemidiaphragmatic paralysis Atrial or ventricular septal defect closure Atrial myxoma Presence of any prosthetic heart valve Hemodynamically significant valvular disease History of pericarditis History of Rheumatic heart disease History of thromboembolic event within 6 months of time of enrollment or evidence of intracardiac thrombus at time of procedure 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vikramaditya Mediratta, MS
Phone
714-717-2376
Email
vmediratta@galaxymedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
James Stambaugh
Phone
408-718-6834
Email
jstambaugh@galatherapeutics.com
Facility Information:
Facility Name
University Hospital of Split
City
Split
ZIP/Postal Code
21000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Sikiric, MD
Phone
38521556255
Email
ivan.sikiric20@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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