Paroxysmal AFCENTAURI RegisNCT07874048
CENTAURI Post-Market Clinical Registry
An observational study of Paroxysmal AF, run by CardioFocus.
Trial summary
The objective of this post-market clinical registry is to collect realworld clinical experience across multiple European centers regarding the safety and efficacy of the CENTAURI System Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal AF
- What is being tested?
- CENTAURI System in conjunction with commercially available ablation catheters
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Dec 2029
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed with paroxysmal AF indicated for an ablation procedure according to society guidelines or participating site practice
Who may be able to join
- Patients diagnosed with paroxysmal AF and indicated for an ablation procedure according to society guidelines or participating site practice
- Age ≥18 years of age
- Patient is willing and able to provide written informed consent
Who cannot join
- Patients who have had an atriotomy within the preceding eight weeks as the recent surgery may increase the risk of perforation
- Patients with a prosthetic heart valve, in which the catheter may pass through, as the catheter may damage the prosthesis
- Patients with active systemic infection, as this may increase the risk for cardiac infection
- Patients with an atrial myxoma or intracardiac thrombus as the catheter could precipitate an embolus
- Patients with an interatrial baffle or patch as the opening could persist and produce an iatrogenic atrial shunt
- In patients who have vena cava embolic protection filter devices and/or known femoral thrombus who require catheter insertion from the femoral approach
- In patients who are hemodynamically unstable, as per physician discretion
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The objective of this post-market clinical registry is to collect realworld clinical experience across multiple European centers regarding the safety and efficacy of the CENTAURI System
Read the detailed description
The objective of this post-market clinical registry is to collect realworld clinical experience across multiple European centers regarding the safety and efficacy of the CENTAURI System when used with three commercially available ablation catheters (i.e., Abbott TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™, Boston Scientific INTELLANAV STABLEPOINT™, Biosense Webster THERMOCOOL SMARTTOUCH™) in standard clinical practice to treat adult patients with paroxysmal AF.
- Conditions
- Paroxysmal AF
- Being tested
- CENTAURI System in conjunction with commercially available ablation catheters
- Keywords
- Paroxysmal AF, PFA, Pulsed Field 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.
CENTAURI System in conjunction with commercially available ablation cathetersDevice
Pulsed Field Ablation using the CENTAURI System
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Outcome
Safety will be assessed through the collection of cardiovascular related, procedure related, and/or device related adverse events (AEs) reported by the participating sites from the day of the index procedure through study exit.
Measured: 24 months
Efficacy Outcome Acute Success
Acute procedure success, defined as PVI of all targeted pulmonary veins using the CENTAURI System.
Measured: at the end of the index ablation procedure
Efficacy Outcome Chronic Success
Freedom from documented AF/AT/AFL from 61 days through 24 months of follow-up, clinically assessed by standard of care rhythm monitoring at participating sites.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal AFStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- CardioFocus
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874048
- Sponsor's protocol ID
- 25-07716
- Acronym
- CENTAURI Regis
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CENTAURI Post-Market Clinical Registry
- ClinicalTrials.gov ID
- NCT07874048
- Acronym / sponsor ID
- CENTAURI Regis / 25-07716
- Conditions
- Paroxysmal AF
- Keywords
- Paroxysmal AF, PFA, Pulsed Field Ablation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- CardioFocusIndustry (pharma, biotech, devices)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 14 Oct 2026 (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.
The objective of this post-market clinical registry is to collect realworld clinical experience across multiple European centers regarding the safety and efficacy of the CENTAURI System
Detailed description
The objective of this post-market clinical registry is to collect realworld clinical experience across multiple European centers regarding the safety and efficacy of the CENTAURI System when used with three commercially available ablation catheters (i.e., Abbott TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™, Boston Scientific INTELLANAV STABLEPOINT™, Biosense Webster THERMOCOOL SMARTTOUCH™) in standard clinical practice to treat adult patients with paroxysmal AF.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with paroxysmal AF indicated for an ablation procedure according to society guidelines or participating site practice
Key inclusion criteria (3 listed)
- Patients diagnosed with paroxysmal AF and indicated for an ablation procedure according to society guidelines or participating site practice
- Age ≥18 years of age
- Patient is willing and able to provide written informed consent
Key exclusion criteria (7 listed)
- Patients who have had an atriotomy within the preceding eight weeks as the recent surgery may increase the risk of perforation
- Patients with a prosthetic heart valve, in which the catheter may pass through, as the catheter may damage the prosthesis
- Patients with active systemic infection, as this may increase the risk for cardiac infection
- Patients with an atrial myxoma or intracardiac thrombus as the catheter could precipitate an embolus
- Patients with an interatrial baffle or patch as the opening could persist and produce an iatrogenic atrial shunt
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 |
|---|---|---|
| CENTAURI System in conjunction with commercially available ablation cathetersPulsed Field Ablation using the CENTAURI System | Device | – |
Primary outcome
Safety Outcome
Time frame: 24 months
Safety will be assessed through the collection of cardiovascular related, procedure related, and/or device related adverse events (AEs) reported by the participating sites from the day of the index procedure through study exit.
Efficacy Outcome Acute Success
Time frame: at the end of the index ablation procedure
Acute procedure success, defined as PVI of all targeted pulmonary veins using the CENTAURI System.
Efficacy Outcome Chronic Success
Time frame: 24 months
Freedom from documented AF/AT/AFL from 61 days through 24 months of follow-up, clinically assessed by standard of care rhythm monitoring at participating sites.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Paroxysmal AF, run by CardioFocus.
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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vikramaditya Mediratta, MS (714-717-2376, vmediratta@cardiofocus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Outcome (time frame: 24 months). 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 14 Oct 2026.