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Pulmonary Artery Pressure monitoring system for patients with Heart Failure
Thomas Heywood, M.D.
This study will evaluate the safety and effectiveness of the CardioMEMS™ HF System for daily monitoring of pulmonary artery (PA) pressure in patients with New York Heart Association (NYHA) Class II, III, or IV Heart Failure with elevated NT-proBNP peptides and/or a prior hospitalization for heart failure. The device data will also be reviewed to look for other indicators of heart failure that may help reduce worsening heart failure and visits to the hospital to treat heart failure symptoms.
Be 18 years of age or older
Be NYHA Class III
Have a heart failure hospitalization within the past 12 month
Be optimally stable on medical therapy for at least 30 days
Patients must not:
Have severe valvular disease that requires repair
Have an active infection
Have had a major cardiovascular event (e.g., unstable angina, myocardial infarction, percutaneous coronary intervention, open heart surgery, stroke, etc.) within 90 days prior to consent
Be enrolled in another trial with an active treatment plan
All patients will be implanted with the CardioMEMS™ device and will have follow-up telephone contacts post-implant at least once every two weeks for the first three months, then monthly until the 12 month follow-up visit. Office visits will occur at 6 and 12 months.
All treatment and physician visits during this study will take place at Anderson Medical Pavilion and/or Prebys Cardiovascular.
Search for NCT# 03387813 at www.clinicaltrials.gov for more information