PulseSelect™ PFA Global Registry

Medtronic Cardiac Ablation Solutions

Status: Enrolling

Conditions: Atrial Fibrillation

Study type: Observational

Funder types: Industry

Identifiers

NCT06393920

PulseSelect™ PFA Registry

Details and patient eligibility

About

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.

Full description

The PulseSelect™ PFA Global Registry is a prospective, global, multi-center, observational post-market registry. The purpose of this clinical study is to collect clinical performance and safety data in a broad patient population treated with the PulseSelect™ PFA system. The PulseSelect™ PFA System used in the study is market approved. The ablation procedure will be performed according to routine hospital practice. The follow up period is intended to align with standard practice and subjects will be followed for a minimum of 12 months post-procedure.

Enrollment: 1,950 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.