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Safety and Efficacy of Workflows of High Volume Single Operators in a LAAO Device Implant Procedural Day

Study on safety and effectiveness of heart device implant procedures.

Recruiting
18 years and older
All
Phase N/A

Study Overview: This study, called SAFE HV, looks at how safe and effective it is when one doctor performs multiple Left Atrial Appendage Occlusion (LAAO) device implantations in a single day. LAAO is a medical procedure that helps prevent strokes in patients with heart issues. The study focuses on doctors who do eight or more of these procedures in one day.

Background: The Watchman FLX™ device has been used since 2009 to help people who can't take blood thinners. This study will see if doing many procedures in one day is as safe as doing them one at a time. It will also gather information to help doctors improve their procedures.

  • The study is observational, meaning researchers just watch and collect data; no one is given new treatments.
  • Participants must be at least 18 years old and willing to attend follow-up evaluations.
  • It is important that participants consent to being part of the study.

Note: People in other clinical trials or those with reasons they should not have the LAAO procedure cannot join this study.

Study details
    Atrial Fibrillation

NCT06436924

Heart Rhythm Clinical and Research Solutions, LLC

1 April 2025

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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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