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Safety and Efficacy Study of reSept ASD Occluder for Treating Secundum ASD

Study on reSept ASD Occluder for Secundum ASD safety and effectiveness.

Recruiting
84 years and younger
All
Phase N/A

The study is testing a device called the reSept ASD Occluder to fix a heart problem known as secundum atrial septal defect (ASD). This condition is a hole in the heart's wall separating the top two chambers, which can cause blood to flow differently than it should. This study aims to see if this device is safe and works well, comparing it to other similar devices already approved by the FDA.

To participate, you must be under 85 years old, weigh at least 33 lbs, and have a specific type of heart hole that needs treatment. You also need to be able to take certain medications like aspirin and heparin, and have a heart structure that can support the device. You should not be pregnant or have serious heart valve problems or other major health issues.

  • The study involves multiple visits to the clinic and requires taking medications for up to 6 months.
  • Participants will be closely monitored to ensure safety and effectiveness of the treatment.
  • Compensation details are not specified, but participants must comply with study requirements.
Study details
    Heart Septal Defect
    Heart Septal Defects
    Atrial
    Heart Defects
    Congenital
    Cardiovascular Abnormalities
    Cardiovascular Diseases
    Heart Diseases
    Congenital Abnormalities

NCT04591392

atHeart Medical

13 December 2024

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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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