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A clinical study of The CardioMEMS™ HF System for the treatment of heart failure (HF)

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

ClinicalTrials.gov Identifier: NCT03387813

ABOUT THIS STUDY

The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS HF System in an expanded patient population including HF patients outside of the present indication, but at risk for future HF events or mortality.

The trial includes patients with New York Heart Association (NYHA) Class II, III, or IV HF patients who have an elevated N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or an elevated Brain Natriuretic Peptide (BNP)) and/or a prior HF hospitalization.

The GUIDE-HF IDE trial will include approximately 3600 subjects at approximately 140 North American sites and consists of two arms: a Randomized Arm and a Single Arm.

Learn More About The CardioMEMS HF System

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ELIGIBILITY CRITERIA

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  • Heart Failure
  • Heart Failure, Systolic
  • Heart Failure, Diastolic
  • Heart Failure NYHA Class II
  • Heart Failure NYHA Class III
  • Heart Failure NYHA Class IV
  • Heart Failure,Congestive
  • Heart Failure With Reduced Ejection Fraction
  • Heart Failure With Normal Ejection Fraction
  • Heart Failure; With Decompensation

The CardioMEMS HF System is made up of the PA pressure sensor itself, an external electronics measurement system and HF website called the Merlin.net™ Patient Care Network (PCN).

  • The sensor is implanted into the distal branch of the descending pulmonary artery.
  • The patient is instructed to take daily pressure readings from home using the external electronics measurement system called the Patients Electronics System (PES).
  • Information is transmitted securely from the PES to the Merlin.net PCN and is immediately available to the clinicians for review.
  • The information consists of systolic, diastolic, and mean pressure trend information and pulmonary artery pressure waveforms.

Males and Females

18 Years and older

  • Diagnosis and treatment for HF (regardless of left ventricular ejection fraction (LVEF)) 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 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
  • Intolerance to all neuro-hormonal antagonists (i.e., intolerance to angiotensin converting enzyme-inhibitors (ACE-I), angiotensin receptor blockers (ARB), angiotensin-neprilysin inhibitors (ARNi), hydralazine/isosorbide dinitrate 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 within 5 years prior to consent) pulmonary emboli and/or deep vein thrombosis
  • 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

TRIAL DETAILS

Study Type: Interventional

  • Estimated Enrollment: 3600 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Treatment
  • Actual Study Start Date: March 15, 2018

Duration

  • Treatment / Follow up: 12 months

Site Visits

  • Screening/Baseline: 1 visit
  • Implant: 1 visit
  • Follow-up: 2 visits (6 months and 12 months)

Trial Procedures

  • Taking daily readings
  • Heart Failure Examination
  • Quality of Life Questionnaires
  • Blood tests
  • Phone contact

Prior Approval

  • The study device has been FDA approved for NYHA Class III HF patients with a HF hospitalization within the prior 12 months.

Trial Sites

View list of Trial sites on
Clinicaltrials.gov

Supporting Data

The CardioMEMS HF System makes a significant difference in patients’ lives.
Proven to improve quality of life1,2, functional capacity1,2, decrease mortality4,5, HF hospitalization1,3 and reduce HF related hospitalization costs3.

In a commercial setting, PA pressure-guided therapy for HF:7

  • Decreased PA pressures
  • Decreased HF hospitalizations by 58%
  • Across all EF ranges
  • Across sex and race
  • Decreased all-cause hospitalization by 28%
  • PA pressure-guided therapy is safe with few device/system related complications (0.3%) and a low rate of pressure sensor failure (0.1%).7 The CardioMEMS HF System is the ONLY heart failure management tool shown to be effective in HFpEF6.

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The CardioMEMS HF System is a product of Abbott, formerly St. Jude Medical

References
  • Abraham WT, et al. The Lancet, 387(10017), 453-461.
    Abraham, W. T., Adamson, P. B., Bourge, R. C., Aaron, M. F., Costanzo, M. R., Stevenson, L. W., et al. (2011). Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomized controlled trial. The Lancet, 377(9766), 658-666.
  • Jermyn R, et al. Clinical Cardiology. doi: 10.1002/clc.22643.
    Jermyn, R., Alam, A., Kvasic, J., Saeed, O., & Jorde, U. (2016). Hemodynamic-guided heart-failure management using a wireless implantable sensor: Infrastructure, methods, and results in a community heart failure disease-management program. Clinical Cardiology. doi: 10.1002/clc.22643.
  • Desai AS, et al. J Am Coll Cardiol, 2017;69(19):2357–65
    Desai AS, Bhimaraj A, Bharmi R, et al. Ambulatory hemodynamic monitoring reduces heart failure hospitalizations in “real-world” clinical practice. J Am Coll Cardiol 2017;69:2357–65.
  • Abraham, et al. Presented at ACC 2018
    Abraham J, Jonsson O, Oliveira G, et al. Lower Mortality and Heart Failure Hospitalization Rates in Patients Implanted with Pulmonary Artery Pressure Sensor – A Real-world Comparative Effectiveness Study (2018) Presented at the 67th Annual Scientific Sessions of the American College of Cardiology. JACC, 2018;71 (11 Supplement) A311.
  • Givertz MM, et al. J Am Coll Cardiol 2017; 70:1875–86.
    Givertz MM, Stevenson LW, Costanzo MR, et al., on behalf of the CHAMPION Trial Investigators. Pulmonary artery pressure–guided management of patients with heart failure and reduced ejection fraction. J Am Coll Cardiol 2017; 70:1875–86
  • Adamson PB, et al. Circulation: Heart Failure, 7(6), 935-944.
    Adamson, P. B., Abraham, W. T., Bourge, R. C., Costanzo, M. R., Hasan, A., Yadav, C., et al. (2014). Wireless pulmonary artery pressure monitoring guides management to reduce decompensation in heart failure with preserved ejection fraction. Circulation: Heart Failure, 7(6), 935-944.
  • Shavelle D, et al. Presented at ACC 2019
    Shavelle DM. Pulmonary artery pressure-guided therapy for ambulatory heart failure patients in clinical practice: 1-year outcomes from the CardioMEMS post-approval study. Presented at: ACC 2019. March 17, 2019. New Orleans, LA
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FOR MORE INFORMATION

Questions about the trial?
Email an Abbott Clinical Trial Contact

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Learn More About The CardioMEMS HF System

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