PulseSelect™ PFA Global Registry
ConditionAtrial Fibrillation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedtronic Cardiac Ablation Solutions
About this trial
The PulseSelect™ PFA Global Registry is a prospective, global, multi-center, observational post-approval study. Subjects will be treated with the PulseSelect™ PFA System and followed according to SOC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject is ≥ 18 years of age or minimum age as required by local regulations.
Subject has been diagnosed with atrial fibrillation (AF)
Planned procedure using commercially available PulseSelect™ PFA System.
Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements.
Disqualifiers
Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager.
Subject with exclusion criteria required by local law.
Trial population
Subjects 18 years or older with a planned procedure using commercially available PulseSelect™ PFA System
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Efficacy-Freedom from Atrial Fibrillation
Estimate the freedom from AF/AFL/AT recurrence following ablation using the PulseSelect™ PFA system.
Time frame
≥ 91 days after the index ablation procedure2
Safety- Freedom from Device/Procedure Related Adverse Events
Estimate serious device and serious procedure-related adverse events for the PulseSelect™ PFA system
Time frame
Within 6 months post-ablationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov