CENTAURI Post-Market Clinical Registry
ConditionParoxysmal AF
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCardioFocus
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Adult patients diagnosed with paroxysmal AF indicated for an ablation procedure according to society guidelines or participating site practice
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
CENTAURI System in conjunction with commercially available ablation catheters
DevicePulsed Field Ablation using the CENTAURI System
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
24 months2
Efficacy Outcome Acute Success
Acute procedure success, defined as PVI of all targeted pulmonary veins using the CENTAURI System.
Time frame
at the end of the index ablation procedure3
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.
Time frame
24 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: