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Investigation of the BrioVAD System for the Treatment of Left Ventricular Heart Failure

Study of BrioVAD System for Left Ventricular Heart Failure Treatment

Recruiting
18 years and older
All
Phase N/A

The study looks at a new device called the BrioVAD System, which helps weak hearts pump blood. The study will compare how safe and effective the BrioVAD is compared to another device, the HeartMate 3, for people with severe heart failure. Heart failure is when your heart doesn’t pump blood as well as it should. The BrioVAD and HeartMate 3 are both types of Left Ventricular Assist Devices (LVADs), which help the left side of the heart to pump blood. The study will take place in multiple hospitals and will compare the two devices to see if BrioVAD is just as good.

  • Participation: Only adults who have been approved for LVAD surgery can join.
  • Duration: The study does not specify the exact length, but it involves significant medical evaluations and possibly surgery.
  • Risks: There are risks related to surgery and device use, such as infection or blood clotting issues.

Before joining, participants need to provide consent, and females need a negative pregnancy test. People with certain health problems, recent heart attacks, or surgeries may not qualify. If interested, speak with your doctor to see if you meet the requirements and understand the potential risks and benefits.

Study details
    Cardiovascular Diseases
    Heart Diseases
    Heart Failure

NCT06310031

BrioHealth Solutions, Inc.

19 January 2025

Step 1 Get in touch with the nearest study center
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  • 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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