Study ID: GUIDE-HF
The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF system in an expanded patient population including heart failure (HF) patients outside of the present indication, but at risk for future HF events or mortality.
This trial is for patients who have been diagnosed with certain types of chronic HF. (Note: The study device has already been FDA approved for NYHA Class III heart failure patients who've been hospitalized within the prior 12 months.)
Participants are grouped into two study arms, and all participants receive the CardioMEMs system, which is a battery-less pressure sensor permanently implanted in the pulmonary artery. The system transmits pressure measurements from the patient to a secure website. Health care personnel access the measurements to remotely manage patients.
This clinical trial includes patients with NYHA Class II, III, or IV HF who have an elevated N-terminal NT-proBNP or an elevated brain natriuretic peptide and/or a prior HF hospitalization.
The GUIDE-HF IDE trial consists of two arms: a randomized arm and a single arm.
- Diagnosis and treatment for heart failure (HF) regardless of left ventricular ejection fraction for > 90 days prior to the date of consent. Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended by current AHA/ACC guidelines as standard-of-care for HF therapy in the U.S., with any intolerance documented
- GUIDE-HF randomized arm only: NYHA Class II, III or IV HF symptoms documented within 30 days prior to consent
- GUIDE-HF single arm only: NYHA Class III HF symptoms documented within 30 days prior to consent
- HF hospitalization within 12 months prior to consent and/or elevated N-terminal pro-brain natriuretic peptide or brain natriuretic peptide within 30 days prior to consent
Other criteria apply. See the website below for more information.
- Must have been diagnosed with Class II, III, or IV heart failure.
- Must be willing and able to upload pulmonary artery pressure information and comply with follow-up requirements.