RecruitingNCT06056271

Clinical and Healthcare Outcomes From Real-World Use in the United States of a Companion AI During AF Ablation

Sponsor

Volta Medical

Enrollment

400 participants

Start Date

Mar 19, 2024

Study Type

OBSERVATIONAL

Conditions

Atrial Fibrillation

Summary

Observational, multi-center, clinical device registry for US patients with a primary goal to observe the clinical outcomes in patients who are mapped with Volta Medical's VX1 or AF-Xplorer systems during AF ablation procedures.

Eligibility

Min Age: 21 Years

Inclusion Criteria5

Patients 21 years of age or older who is:
indicated for AF ablation or
Who has received an AF-ablation with the past 24 months where VX1 was used or
Patients are receiving or received a catheter ablation procedure for AF according to current guidelines
Patients must be able and willing to provide written informed consent to participate in the clinical trial

Exclusion Criteria4

Patients not indicated or were not indicated for catheter ablation according to current guidelines
Patients with AF secondary to an obvious reversible cause
Patients who are or may potentially be pregnant
Enrollment in an investigational study evaluating another non-VX1 investigational device, biologic, or drug