Hemodynamic-Guided Management of Heart Failure (CIP-10170)

Brief description of study

The purpose of this research study is to see if a heart pressure sensor called the CardioMEMS™ PA Sensor (referred to as “the device”) within the CardioMEMS™ HF System can improve health outcomes of people with heart failure. This small sensor is implanted into the heart on the tip of a catheter and through a vein. It takes a daily reading of the pulmonary artery pressure, which reflects the pressures within the heart. The pulmonary artery pressure reading is sent to a secure website that your study doctor can see to help him/her adjust your treatment (usually changes in medications). Ideally, this is to be done before the symptoms get too serious. The CardioMEMS™ HF System received FDA approval for patients who have New York Heart Association (NYHA) Class III heart failure and history of a hospitalization for heart failure in the prior year. In this study, the CardioMEMS™ HF System is considered experimental because it will be used for patients who have been assessed as NYHA Class II or NYHA Class IV and for NYHA Class III patients without a hospitalization for heart failure in the last year.

Clinical Study Identifier: s19-00760

ClinicalTrials.gov Identifier: NCT03387813

Principal Investigator: Tajinderpal Saraon.

Other Investigators: Josephine Quinlan, Meifung K Schuman, Maureen Coletta Geary, Alyssa Nicole Amerosa, Rebecca Reich, Alex Reyentovich, Shaline D Rao, Mauli Patel.

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