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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorVolta Medical

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • AF Ablation

Treatment groups

No treatment groups listed

Sponsors and collaborators

Volta Medical

Lead sponsor

Heart Rhythm Clinical and Research Solutions, LLC

Collaborator