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

Volta Medical

Status: Enrolling

Conditions: Atrial Fibrillation

Treatments: Device: AF Ablation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06056271

CLIPL-01-005

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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

2. Patients are receiving or received a catheter ablation procedure for AF according to current guidelines

3. Patients must be able and willing to provide written informed consent to participate in the clinical trial

Exclusion criteria

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