CardioMEMS HF System Post Approval Study
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|ClinicalTrials.gov Identifier: NCT02279888|
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : April 7, 2020
|Condition or disease||Intervention/treatment|
|Heart Failure Left-Sided Heart Failure Congestive Heart Failure||Device: CardioMEMS HF System|
The primary objective of this study is to demonstrate the safety and to report clinical performance of the CardioMEMS™ HF System in real world setting.
Prospective, non-randomized, open-label, multi-center, post-market study designed to characterize the use of the CardioMEMS™ HF System in a real-world setting in the US; N=1200. It is the condition of approval study.
|Study Type :||Observational|
|Actual Enrollment :||1200 participants|
|Official Title:||CardioMEMS HF System Post Approval Study|
|Actual Study Start Date :||January 2015|
|Actual Primary Completion Date :||October 11, 2019|
|Actual Study Completion Date :||February 3, 2020|
CardioMEMS HF System Group
Patients implanted with a CardioMEMS HF System.
Device: CardioMEMS HF System
Pulmonary artery pressure sensor
- freedom from device/system related complication [ Time Frame: two year ]
- freedom from pressure sensor failure [ Time Frame: two year ]
- heart failure hospitalization rate [ Time Frame: one year ]
- all-cause mortality [ Time Frame: one year ]
- heart failure hospitalization or death rate [ Time Frame: one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279888
|United States, West Virginia|
|West Virginia Heart Institute|
|Morgantown, West Virginia, United States, 26505|
|Study Chair:||Lynne Stevenson, MD||Brigham and Women's|