Atrial FibrillationSPACE AFNCT04652778
Safety & Performance of the Centauri System for Patients With Atrial Fibrillation
A study testing Pulsed Field Ablation (PFA) using the Centauri System in people with Atrial Fibrillation, run by Galaxy Medical, Inc. at 1 site in Canada.
Trial 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). 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?
- Pulsed Field Ablation (PFA) using the Centauri System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 15 Sep 2021to 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
- Age 18 through 75 years-old on the day of 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 full 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
- Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the index ablation procedure
- Use of amiodarone within 6 weeks prior to enrollment
- Prior left atrial ablation or surgical procedure (including left atrial appendage (LAA) device or occlusion)
Show all 25Show fewer
- 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))
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety & Performance of Ablation With the Centauri System for the Elimination of Atrial Fibrillation (SPACE AF)
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).
- Conditions
- Atrial Fibrillation
- Being tested
- Pulsed Field Ablation (PFA) using the Centauri System
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Field Ablation (PFA) using the Centauri SystemDevice
cardiac ablation using pulsed electric field energy to cause pulmonary vein isolation; cavo-tricuspid isthmus (CTI) line ablation may be performed as needed
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Device: Pulsed Field Ablation (PFA) using the Centauri System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device and Procedure related serious adverse event rate
The rate of system-related and procedure-related serious adverse events of interest
Measured: 30 days
Acute Procedural Success
Proportion of patients with confirmed pulmonary vein isolation (PVI) during the index procedure
Measured: During treatment procedure
Chronic Success
Proportion of patients with freedom from AF recurrence after a single procedure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start15 Sep 2021
- 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galaxy Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652778
- Sponsor's protocol ID
- CSP-00008
- Acronym
- SPACE AF
- Status last verified
- Aug 2022
- First submitted
- 20 Nov 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 of Ablation With the Centauri System for the Elimination of Atrial Fibrillation (SPACE AF)
- ClinicalTrials.gov ID
- NCT04652778
- Acronym / sponsor ID
- SPACE AF / CSP-00008
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Galaxy Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 3 Dec 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 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).
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: Pulsed Field Ablation (PFA) using the Centauri System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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:
- Age 18 through 75 years-old on the day of 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.
Key exclusion criteria (25 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
- Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the index ablation procedure
- Use of amiodarone within 6 weeks prior to enrollment
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 |
|---|---|---|
| Pulsed Field Ablation (PFA) using the Centauri Systemcardiac ablation using pulsed electric field energy to cause pulmonary vein isolation; cavo-tricuspid isthmus (CTI) line ablation may be performed as needed | Device | Treatment |
Primary outcome
Device and Procedure related serious adverse event rate
Time frame: 30 days
The rate of system-related and procedure-related serious adverse events of interest
Acute Procedural Success
Time frame: During treatment procedure
Proportion of patients with confirmed pulmonary vein isolation (PVI) during the index procedure
Chronic Success
Time frame: 12 months
Proportion of patients with freedom from AF recurrence after a single procedure
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.
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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
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Field Ablation (PFA) using the Centauri System in people with Atrial Fibrillation, run by Galaxy Medical, Inc. at 1 site in Canada.
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 7 inclusion and 25 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 Canada. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device and Procedure related serious adverse event rate (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.