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

Launched by VOLTA MEDICAL · Sep 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of a special AI technology called Volta Medical's VX1 during procedures for a condition known as atrial fibrillation (AF), which affects the heart’s rhythm. The goal is to see how well this AI helps in the mapping process during AF ablation, a treatment that aims to restore a normal heartbeat. The trial is currently recruiting participants across multiple centers in the United States.

To participate, you need to be at least 21 years old and either be scheduled for an AF ablation procedure or have had one in the past 24 months where the VX1 system was used. You’ll also need to be able to give your written consent to join the study. If you’re interested, you can expect to be part of a study that helps researchers understand how this AI can improve care for patients with AF. However, if your AF is caused by a temporary issue or if you are pregnant, you won’t be eligible to join. This trial offers a chance to contribute to important research that could benefit future patients with similar heart conditions.

Gender

ALL

Eligibility criteria

• 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