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

Volta Medical4 sites in 1 country400 target enrollmentMarch 19, 2024

ConditionsAtrial Fibrillation

Overview

Phase: N/A
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: Volta Medical
Enrollment: 400
Locations: 4
Primary Endpoint: Primary Clinical Efficacy Outcome
Status: Recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 19, 2024

End Date

December 1, 2027

Last Updated

4 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Volta Medical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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

Outcomes

Primary Outcomes

Primary Clinical Efficacy Outcome

Time Frame: 12 and 24 months

Percentage of subjects free from clinically significant AF or atrial arrhythmia recurrences, after one or multiple ablation procedures, stratified by type of clinical workflow and ablation history.