Atrial FibrillationECLIPSE AFNCT04523545
Safety & Clinical Performance Study of Catheter Ablation With the Centauri System for Patients With Atrial Fibrillation
A study testing cardiac ablation in people with Atrial Fibrillation, run by Galaxy Medical, Inc. at 1 site in Croatia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- cardiac ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCroatia
- Study dates
- 28 Sep 2020to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
University Hospital of Split
Split, 21000
Ivan Sikiric, MD, 38521556255, ivan.sikiric20@gmail.com
About this study
Official title: Safety & Performance Study of the Centauri System for Patients With Atrial Fibrillation
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
- Being tested
- cardiac ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac ablationDevice
cardiac ablation using pulsed electric field energy to cause pulmonary vein isolation
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Device: cardiac ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of device and procedure related serious adverse events
The rate of system-related and procedure-related serious adverse events (SAEs)
Measured: 30 days
Acute Procedural Success
Proportion of patients with confirmed pulmonary vein isolation (PVI) during the index procedure
Measured: During treatment 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
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start28 Sep 2020
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Galaxy Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523545
- Sponsor's protocol ID
- CSP-00007
- Acronym
- ECLIPSE AF
- Status last verified
- Aug 2022
- First submitted
- 19 Aug 2020
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety & Performance Study of the Centauri System for Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04523545
- Acronym / sponsor ID
- ECLIPSE AF / CSP-00007
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Galaxy Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 21 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: cardiac ablation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- 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.
Key exclusion criteria (26 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiac ablationcardiac ablation using pulsed electric field energy to cause pulmonary vein isolation | Device | Treatment |
Primary outcome
Rate of device and procedure related serious adverse events
Time frame: 30 days
The rate of system-related and procedure-related serious adverse events (SAEs)
Acute Procedural Success
Time frame: 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
Time frame: 90 days
Proportion of patients with documented electrical isolation of the pulmonary veins
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
Related trials for Atrial Fibrillation
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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CONVERGE Post-Approval Study (PAS)
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardiac ablation in people with Atrial Fibrillation, run by Galaxy Medical, Inc. at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vikramaditya Mediratta, MS (714-717-2376, vmediratta@galaxymedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of device and procedure related serious adverse events (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022.