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

Exploring reSept ASD Occluder for Secundum ASD treatment trial safety.

Recruiting
84 years and younger
All
Phase N/A

This study looks at the safety and effectiveness of using the reSept ASD Occluder to treat a heart problem called secundum atrial septal defect (ASD). ASD is a hole in the heart between the upper chambers. The study will compare results with other devices approved by the FDA, which is the agency that checks if medical devices are safe.

The study has some rules for who can join. You must be under 85 years old, weigh at least 33 pounds, and have a specific type of ASD. If you are a female and can have children, you will need a pregnancy test. You cannot join if you have certain heart problems, infections, or are pregnant. You also need to be able to take medications like aspirin and heparin.

  • The study is done in multiple places and has three stages.
  • Participants must take certain medications before and after the procedure.
  • You need to give permission to join the study, or a parent/guardian must do so if you are a minor.
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

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

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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