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NCT07874048
CENTAURI Post-Market Clinical Registry
Conditions: Paroxysmal AF
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 300
Sponsor: CardioFocus
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
Eligibility Criteria
Inclusion Criteria:
1. Patients diagnosed with paroxysmal AF and indicated for an ablation procedure according to society guidelines or participating site practice
2. Age ≥18 years of age
3. Patient is willing and able to provide written informed consent
Exclusion Criteria:
1. Patients who have had an atriotomy within the preceding eight weeks as the recent surgery may increase the risk of perforation
2. Patients with a prosthetic heart valve, in which the catheter may pass through, as the catheter may damage the prosthesis
3. Patients with active systemic infection, as this may increase the risk for cardiac infection
4. Patients with an atrial myxoma or intracardiac thrombus as the catheter could precipitate an embolus
5. Patients with an interatrial baffle or patch as the opening could persist and produce an iatrogenic atrial shunt
6. In patients who have vena cava embolic protection filter devices and/or known femoral thrombus who require catheter insertion from the femoral approach
7. In patients who are hemodynamically unstable, as per physician discretion
Source: ClinicalTrials.gov (NCT07874048). StuddyBuddy aggregates publicly available trial information.