CardioMEMSTM HF System Post Approval Study

  • STATUS
    Recruiting
  • sponsor
    St. Jude Medical
Updated on 23 November 2020

Summary

CardioMEMSTM HF System Post Approval Study

Description

The CardioMEMS HF System provides a method to measure pulmonary artery (PA) pressures by using a small wireless sensor (about the size of a paperclip) implanted into the pulmonary artery (a vessel close to your heart). Once implanted, the sensor communicates through radio frequency to an antenna contained in a pillow connected to an electronic unit and then transmits this valuable information to a secure website for your doctor to review. You will be able to take these PA pressure measurements yourself at home. In addition to these home readings, your PA pressures can also be obtained in the physician’s office, clinic, or hospital. Your doctor can access the secure website to view your measurements allowing him/her to make earlier treatment changes (usually changes in medications) to manage your heart failure remotely.

The FDA approved the CardioMEMS HF System for commercial use in the USA in May of 2014. Part of the FDA’s responsibility to the public is to make sure that medical devices are safe and work correctly after they are approved. As such, the FDA has requested the sponsor of the device, St. Jude Medical, conduct a Post Approval Study (PAS). This study can give patients, doctors, the sponsor, and the FDA valuable information on the safety, effectiveness and reliability of the CardioMEMS HF System.

Details
Clinical Study IdentifierTX142584
SponsorSt. Jude Medical
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

You are willing to review and sign an informed consent
You are at least 18 years old
You have been diagnosed with heart failure and have been classified as NYHA Class III
You have experienced at least 1 hospitalization within the past 12 months because of your heart failure
Your Body Mass Index (a calculation using your weight and height) is acceptable for the study
You are willing to comply with the requirements of the study, including taking PA pressure readings from home as directed by your doctor
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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