Affera Global Registry

Medtronic Cardiac Ablation Solutions

Status: Enrolling

Conditions: Atrial Fibrillation

Treatments: Device: Affera Platform

Study type: Observational

Funder types: Industry

Identifiers

NCT06026345

Affera Global Registry

Details and patient eligibility

About

The Affera Global Registry is a prospective, global, multi-center, observational post-market registry (PMR). The purpose of this study is to describe clinical performance and safety data in a broad patient population treated with the Affera Platform.

Enrollment: 540 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
• Planned procedure using the commercially available Affera Platform
• Willing and able to comply with study requirements and give IC (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

Trial design

540 participants in 1 patient group

Treatment Arm

Description:

Patients enrolled and treated with the Affera Platform

Treatment:

Device: Affera Platform