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

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

Recruiting
21 years and older
All
Phase N/A

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Overview

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-Explorer systems during AF ablation procedures.

Eligibility

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

Study details
    Atrial Fibrillation

NCT06056271

Volta Medical

1 May 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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