PulseSelect™ PFA Global Registry

Launched by MEDTRONIC CARDIAC ABLATION SOLUTIONS · Apr 28, 2024

Keywords

ClinConnect Summary

The PulseSelect™ PFA Global Registry is a study designed to gather information about the PulseSelect™ PFA System, which is a treatment for people diagnosed with atrial fibrillation (AF), a condition that affects the heart's rhythm. This study is open to adults aged 18 and older who are planning to receive treatment using this system. Participants will be followed over time to see how well the treatment works and to ensure their safety.

To be part of this study, you need to have a diagnosis of atrial fibrillation and be willing to give your consent to participate. It’s important to note that if you are already involved in another clinical study, you may not be eligible for this one. If you join, you can expect regular check-ins and assessments as part of the follow-up process. This study aims to improve understanding of the PulseSelect™ PFA System and how it can help people with atrial fibrillation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.