CardioMEMSTM HF System Post Approval Study
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- STATUS
- Recruiting
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- sponsor
- St. Jude Medical
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
| Condition | Congestive Heart Failure, High Blood Pressure (Hypertension) |
|---|---|
| Clinical Study Identifier | TX142584 |
| Sponsor | St. Jude Medical |
| Last Modified on | 23 November 2020 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf 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.
Learn moreComplete 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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