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

Studying safety of heart implant procedures by experienced doctors.

Recruiting
18 years and older
All
Phase N/A

SAFE HV is a study to see how safe and effective it is for doctors to do eight or more left atrial appendage occlusion (LAAO) device implants in one day. A left atrial appendage occlusion device is used to help prevent blood clots in the heart. The Watchman FLX™ is a type of LAAO device that has helped many patients since 2009. This study wants to find out if doing many implants in one day is just as safe as doing fewer. The study will also look at how doctors manage to do so many implants and if this can help other doctors in the future.

  • Length of Study: Participants need to attend follow-up visits for the full study duration.
  • Eligibility: Must be 18 or older and qualify for the LAAO device.
  • Participation: Requires signing a consent form and procedures are done on high-volume days.

If you join, this can help improve how doctors perform these important procedures and may help more patients in the future.

Study details
    Atrial Fibrillation

NCT06436924

Heart Rhythm Clinical and Research Solutions, LLC

16 February 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

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

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

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

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