Companion AI for Atrial Fibrillation

(COMPANION AI Trial)

Recruiting at 3 trial locations

Overseen By Daniel Guerrero

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Volta Medical

Disqualifiers: Pregnancy, Other investigational study, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to observe real-world outcomes for patients undergoing atrial fibrillation (AF) ablation procedures using special AI mapping systems, VX1 or AF-Explorer. The research focuses on how these systems might enhance the procedure's success and patient recovery. It is ideal for individuals who have had or are scheduled for an AF ablation, a procedure to correct irregular heartbeats, and are open to sharing their experiences. Participants must consent to the study and should not have AF due to a reversible cause. As a Phase 4 trial, this research involves an FDA-approved treatment, providing insights into its benefits for a broader patient population.

Why are researchers excited about this trial?

Researchers are excited about the use of a Companion AI during AF ablation because it adds a cutting-edge layer of precision and personalization to the procedure. Unlike traditional methods that rely solely on the clinician's expertise and standard imaging techniques, this AI can analyze real-time data to provide insights that may enhance decision-making during the ablation. This could potentially lead to improved outcomes and reduced complications by tailoring the treatment more closely to each patient's unique cardiac patterns. By integrating advanced technology into the procedure, the AI aims to elevate the effectiveness of AF ablation, making it a promising advancement in the treatment of atrial fibrillation.

Are You a Good Fit for This Trial?

Inclusion Criteria

You have undergone catheter ablation for Atrial Fibrillation within the past 24 months, or you are receiving it according to current guidelines.

Participants must exhibit the capacity and willingness to grant written permission for involvement in the clinical trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ablation Procedure

Participants undergo AF ablation procedures using Volta Medical's VX1 or AF-Explorer systems

1 day

Follow-up

Participants are monitored for safety and effectiveness after ablation procedures

24 months

What Are the Treatments Tested in This Trial?

Who Is Running the Clinical Trial?

Volta Medical

Lead Sponsor

Trials

6

Recruited

1,300+

Heart Rhythm Clinical and Research Solutions, LLC

Collaborator

Trials

8

Recruited

20,100+