Hemodynamic-Guided Management of Heart Failure (CIP-10170)
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Heart Failure
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Age: Between 18 - 110 Years
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Gender: Male or Female
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Other Inclusion Criteria:
- Subjects have diagnosis and treatment for Heart Failure (HF) for > 90 days
- Subjects be on stable, optimally titrated medical therapy for at least 30 days
- 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.
- Subjects who had Heart Failure Hospitalization (HFH) within 12 months prior to consent and/or elevated NT-proBNP (or BNP) within 30 days prior to consent
- Subjects who are 18 years or older
- Chest circumference of < 65 inches, if BMI is > 35 kg/m2
- Able to understand and provide written informed consent
- Subjects who are willing and able to upload PA pressure information and comply with the follow-up requirements as per the protocol
You may not be eligible for this study if the following are true:
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- Subjects with intolerance to all neuro-hormonal antagonists
- Subjects with ACC/AHA Stage D refractory Heart Failure (HF)
- Those who received or are likely to receive an advanced therapy
- NYHA Class IV HF patients with:
- Continuous or chronic use of scheduled intermittent inotropic therapy for HF and an INTERMACS level of = 4, OR
- Persistence of fluid overload with maximum (or dose equivalent) diuretic intervention
- Those who have Glomerular Filtration Rate (eGFR) < 25 mL/min/1.73m2 and non-responsive to diuretic therapy, or receiving chronic dialysis
- Subjects with inability to tolerate or receive dual antiplatelet therapy or anticoagulation therapy for one month post-implantation
- Subjects with significant congenital heart disease that has not been repaired and would prevent implantation of the CardioMEMS™ PA Sensor
- Those with implanted with mechanical right heart valve(s) or unrepaired severe valvular disease
- Subjects who are pregnant or plan to become pregnant in the next 12 months
- An active, ongoing infection, defined as being febrile, an elevated white blood cell count, on intravenous antibiotics, and/or positive cultures
- Subjects who have history of current or recurrent pulmonary emboli and/or deep vein thromboses
- Those who had major cardiovascular event within 90 days prior
- Subjects who have been implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRTDefibrillator (CRT-D)
- Subjects who enrolled in another trial
- Those who have an anticipated life expectancy of < 12 months
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.