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Active Clinical Trials

Hemodynamic-GUIDEd Management of Heart Failure (GUIDE-HF)

Active NCT:
03387813
Allegheny General Hospital
Allegheny General Hospital

Sponsor: 
St. Jude Medical
Contact: 

For more information, please contact Joan Rossi at 412-359-3293 or Joan.Rossi@ahn.org.

Hemodynamic-GUIDEd Management of Heart Failure (GUIDE-HF)

Purpose: 

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.

Ages Eligible for Study:  18 Years and older   (Adult, Senior)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

Inclusion Criteria:

Diagnosis and treatment for heart failure (HF) (regardless of left ventricular ejection fraction (LVEF)) for > 90 days prior to the date of consent:

a. Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current American Heart Association (AHA)/American College of Cardiology (ACC) guidelines as standard-of-care for HF therapy in the United States, 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 (HFH) within 12 months prior to consent and/or elevated N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or Brain Natriuretic Peptide (BNP)) within 30 days prior to consent defined as:

Subjects with LVEF ≤ 40%: NT-proBNP ≥ 1000 pg/mL (or BNP ≥ 250 pg/mL).

Subjects with LVEF > 40%: NT-proBNP ≥ 700 pg/mL (or BNP ≥ 175 pg/mL).

Thresholds for NT-proBNP and BNP (for both LVEF ≤ 40% and LVEF > 40%) will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 25 kg/m2

≥ 18 years of age

Chest circumference of < 65 inches, if BMI is > 35 kg/m2

Written informed consent obtained from subject

Willing and able to upload pulmonary artery (PA) pressure information and comply with the follow-up requirements

Exclusion Criteria:

Intolerance to all neuro-hormonal antagonists (i.e., intolerance to angiotensin converting enzyme-inhibitors (ACE-I), angiotensin receptor blockers (ARB), angiotensin-neprilysin inhibitors (ARNi), and beta-blockers)

ACC/AHA Stage D refractory HF (including having received or currently receiving pharmacologic circulatory support with inotropes)

Received or are likely to receive an advanced therapy (e.g., mechanical circulatory support or cardiac transplant) in the next 12 months

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

Glomerular Filtration Rate (eGFR) < 25 mL/min and non-responsive to diuretic therapy, or receiving chronic dialysis

Inability to tolerate or receive dual antiplatelet therapy or anticoagulation therapy for one month post-implantation

Significant congenital heart disease that has not been repaired and would prevent implantation of the CardioMEMS™ PA Sensor

Implanted with mechanical right heart valve(s)

Unrepaired severe valvular disease

Pregnant or planning 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 (blood, sputum or urine).

History of current or recurrent (≥ 2 episodes) pulmonary emboli and/or deep vein thromboses

Major cardiovascular event (e.g., unstable angina, myocardial infarction, percutaneous coronary intervention, open heart surgery, or stroke, etc.) within 90 days prior to consent

Implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) for less than 90 days prior to consent

Enrollment into another trial with an active treatment arm

Anticipated life expectancy of < 12 months

Any condition that, in the opinion of the Investigator, would not allow for utilization of the CardioMEMS™ HF System to manage the subject using information gained from hemodynamic measurements to adjust medications, including the presence of unexpectedly severe pulmonary hypertension (e.g., trans-pulmonary gradient >15) at implant right heart catheterization (RHC), a history of non-compliance, or any condition that would preclude CardioMEMS™ PA Sensor implantation