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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03387813
Other study ID # CIP-10170
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 15, 2018
Est. completion date May 17, 2023

Study information

Verified date August 2022
Source Abbott Medical Devices
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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 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 (HFH). 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.


Recruitment information / eligibility

Status Completed
Enrollment 2358
Est. completion date May 17, 2023
Est. primary completion date May 17, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. 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. 2. GUIDE-HF Randomized Arm Only: NYHA Class II, III or IV HF symptoms documented within 30 days prior to consent. 3. GUIDE-HF Single Arm Only: NYHA Class III HF symptoms documented within 30 days prior to consent. 4. 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: 1. Subjects with LVEF = 40%: NT-proBNP = 1000 pg/mL (or BNP = 250 pg/mL). 2. Subjects with LVEF > 40%: NT-proBNP = 700 pg/mL (or BNP = 175 pg/mL). 3. 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 5. = 18 years of age 6. Chest circumference of < 65 inches, if BMI is > 35 kg/m2 7. Written informed consent obtained from subject 8. Willing and able to upload pulmonary artery (PA) pressure information and comply with the follow-up requirements Exclusion Criteria: 1. 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) 2. ACC/AHA Stage D refractory HF (including having received or currently receiving pharmacologic circulatory support with inotropes) 3. Received or are likely to receive an advanced therapy (e.g., mechanical circulatory support or cardiac transplant) in the next 12 months 4. NYHA Class IV HF patients with: 1. Continuous or chronic use of scheduled intermittent inotropic therapy for HF and an INTERMACS level of = 4, OR 2. Persistence of fluid overload with maximum (or dose equivalent) diuretic intervention 5. Glomerular Filtration Rate (eGFR) < 25 mL/min and non-responsive to diuretic therapy, or receiving chronic dialysis 6. Inability to tolerate or receive dual antiplatelet therapy or anticoagulation therapy for one month post-implantation 7. Significant congenital heart disease that has not been repaired and would prevent implantation of the CardioMEMS™ PA Sensor 8. Implanted with mechanical right heart valve(s) 9. Unrepaired severe valvular disease 10. Pregnant or planning to become pregnant in the next 12 months 11. 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). 12. History of current or recurrent (= 2 episodes within 5 years prior to consent) pulmonary emboli and/or deep vein thrombosis 13. Major cardiovascular event (e.g., unstable angina, myocardial infarction, percutaneous coronary intervention, open heart surgery, or stroke, etc.) within 90 days prior to consent 14. Implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) for less than 90 days prior to consent 15. Enrollment into another trial with an active treatment arm 16. Anticipated life expectancy of < 12 months 17. 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
CardioMEMS™ HF System
The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.

Locations

Country Name City State
Canada Foothills Medical Centre Calgary Alberta
Canada Southlake Regional Health Centre Newmarket Ontario
Canada Toronto General Hospital Toronto Ontario
Canada Vancouver General Hospital (U of BC) Vancouver British Columbia
United States Abington Memorial Hospital Abington Pennsylvania
United States Akron City Hospital Akron Ohio
United States New Mexico Heart Institute Albuquerque New Mexico
United States University of Michigan Ann Arbor Michigan
United States Piedmont Athens Regional Medical Center Athens Georgia
United States McLaren Health Care Corporation Auburn Hills Michigan
United States University Hospital Augusta Georgia
United States University of Colorado Hospital Aurora Colorado
United States Acension Texas Cardiovascular Austin Texas
United States Austin Heart Austin Texas
United States Our Lady of the Lake Hospital Baton Rouge Louisiana
United States Brigham and Women's Hospital Boston Massachusetts
United States Bethesda Memorial Hospital Boynton Beach Florida
United States Deborah Heart and Lung Center Browns Mills New Jersey
United States Carolinas Medical Center Charlotte North Carolina
United States Morton Plant Hospital Clearwater Florida
United States The Cleveland Clinic Foundation Cleveland Ohio
United States University Hospitals Cleveland Medical Center Cleveland Ohio
United States Prisma Health-Midlands Columbia South Carolina
United States Ohio Health Research Institute Columbus Ohio
United States Ohio State University Columbus Ohio
United States John Muir Medical Center Concord California
United States Baylor University Hospital Dallas Texas
United States Adventist Health St. Helena Deer Park California
United States Henry Ford Hospital Detroit Michigan
United States Northshore University HealthSystem Evanston Illinois
United States Providence Everett Medical Center Everett Washington
United States Virginia Heart - The Cardiovascular Group, P.C. Falls Church Virginia
United States Washington Regional Medical Center Fayetteville Arkansas
United States John Peter Smith Hospital Fort Worth Texas
United States North Colorado Medical Center Greeley Colorado
United States Greenville Health System Greenville South Carolina
United States Vidant Medical Center Greenville North Carolina
United States Hackensack University Medical Center Hackensack New Jersey
United States Pinnacle Health System Harrisburg Pennsylvania
United States Hartford Hospital Hartford Connecticut
United States Penn State Milton S. Hershey Medical Center Hershey Pennsylvania
United States Memorial Regional Hospital Hollywood Florida
United States Cardiovascular Institute of the South Houma Louisiana
United States CHI St. Luke's Health Baylor College of Medicine Med. Ctr. Houston Texas
United States Memorial Hermann Hospital Houston Texas
United States Park Plaza Hospital Houston Texas
United States The Methodist Hospital Houston Texas
United States St. Vincent Hospital Indianapolis Indiana
United States First Coast Cardiovascular Institute Jacksonville Florida
United States Memorial Hospital Jacksonville Jacksonville Florida
United States Kansas University Medical Center Kansas City Kansas
United States St. Luke's Hospital Kansas City Missouri
United States Tennova Healthcare - Turkey Creek Medical Center Knoxville Tennessee
United States Scripps Health La Jolla California
United States University of California at San Diego (UCSD) Medical Center La Jolla California
United States Lancaster General Hospital Lancaster Pennsylvania
United States Sparrow Clinical Research Institute Lansing Michigan
United States BryanLGH Heart Institute Lincoln Nebraska
United States Arkansas Heart Hospital Little Rock Arkansas
United States Baptist Health Medical Center Little Rock Arkansas
United States South Denver Cardiology Associates PC Littleton Colorado
United States Saint Barnabas Medical Center Livingston New Jersey
United States Ronald Reagan UCLA Medical Center Los Angeles California
United States USC University Hospital Los Angeles California
United States Catholic Medical Center Manchester New Hampshire
United States WellStar Kennestone Hospital Marietta Georgia
United States Methodist University Hospital Memphis Tennessee
United States Heart Center of Lake County Merrillville Indiana
United States Mercy Hospital Miami Florida
United States MidMichigan Medical Center-Midland Midland Michigan
United States Aurora Medical Group Milwaukee Wisconsin
United States Minneapolis Heart Institute Minneapolis Minnesota
United States University of Minnesota Medical Center Fairview Minneapolis Minnesota
United States Midwest Cardiovascular Institute Naperville Illinois
United States St Thomas Hospital Nashville Tennessee
United States Vanderbilt University Medical Center Nashville Tennessee
United States Yale New Haven Hospital New Haven Connecticut
United States Louisiana State University Health Sciences Center New Orleans Louisiana
United States Ochsner Medical Center New Orleans Louisiana
United States Mount Sinai Hospital New York New York
United States New York University Hospital New York New York
United States New York-Presbyterian/Columbia University New York New York
United States Sentara Norfolk General Hospital Norfolk Virginia
United States North Kansas City Hospital North Kansas City Missouri
United States Advocate Health and Hospitals Corporation Oakbrook Terrace Illinois
United States Integris Baptist Medical Center Oklahoma City Oklahoma
United States Oklahoma Heart Hospital South Oklahoma City Oklahoma
United States University of Nebraska Medical Center Omaha Nebraska
United States Advent Health Orlando Orlando Florida
United States Orlando Regional Medical Center Orlando Florida
United States Albert Einstein Medical Center Philadelphia Pennsylvania
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania
United States Arizona Cardiovascular Research Center Phoenix Arizona
United States Banner-University Medical Center Phoenix Phoenix Arizona
United States Phoenix Cardiovascular Research Group Phoenix Arizona
United States Allegheny General Hospital - ASRI Pittsburgh Pennsylvania
United States Providence Heart and Vascular Portland Oregon
United States Hudson Valley Cardiovascular Practice, P.C. Poughkeepsie New York
United States Rhode Island Hospital Providence Rhode Island
United States NC Heart and Vascular Research Raleigh North Carolina
United States WakeMed Hospital Raleigh North Carolina
United States Eisenhower Medical Center Rancho Mirage California
United States Renown Regional Medical Center Reno Nevada
United States Bon Secours Heart & Vascular Institute Richmond Virginia
United States Mayo Clinic Rochester Minnesota
United States Rochester General Hospital Rochester New York
United States St. Francis Hospital Roslyn New York
United States Mercy Medical Group - Cardiology Sacramento California
United States Sutter Medical Center, Sacramento Sacramento California
United States St. Cloud Hospital Saint Cloud Minnesota
United States Mercy Hospital St. Louis Saint Louis Missouri
United States Methodist Healthcare System of San Antonio San Antonio Texas
United States San Diego Cardiac Center San Diego California
United States California Pacific Medical Center - Van Ness Campus San Francisco California
United States Swedish Medical Center - Heart & Vascular Seattle Washington
United States University of Washington Medical Center Seattle Washington
United States Advanced Cardiovascular Specialists Shreveport Louisiana
United States Sanford USD Medical Center Sioux Falls South Dakota
United States Providence Hospital Southfield Michigan
United States Tampa General Hospital Tampa Florida
United States University of Arizona Tucson Arizona
United States Oklahoma Heart Institute at Utica Tulsa Oklahoma
United States Ventura Cardiology Consultants Ventura California
United States Lourdes Cardiology Services Voorhees New Jersey
United States George Washington University Hospital Washington District of Columbia
United States Waukesha Memorial Hospital Waukesha Wisconsin
United States Aspirus Wausau Hospital Wausau Wisconsin
United States Iowa Heart Center West Des Moines Iowa
United States The Reading Hospital and Medical Center West Reading Pennsylvania
United States Cardiovascular Research Institute of Kansas Wichita Kansas
United States Winchester Medical Center Winchester Virginia
United States University of Massachusetts Worcester Massachusetts
United States Main Line Health Center/Lankenau Hospital Wynnewood Pennsylvania
United States St. Elizabeth Health Center Youngstown Ohio

Sponsors (1)

Lead Sponsor Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other (Randomized Arm) Cardiovascular mortality The number of deaths with cardiovascular cause 12 months post-implantation
Other (Randomized Arm) All-cause hospitalizations The number of hospitalizations of any cause 12 months post-implantation
Other (Randomized Arm) Frequency of subject PA pressure uploads The frequency of subject uploads of PA pressure 12 months post-implantation
Other (Randomized Arm) Frequency of clinician review of subject PA pressure uploads The frequency of clinician review of subject uploads of PA pressure 12 months post-implantation
Other (Randomized Arm) HF medication changes The number of changes in HF medications 12 months post-implantation
Other (Randomized Arm) PA pressure measurements PA pressure measurements Baseline through 12 months post-implantation
Other (Randomized Arm) NT-proBNP (or BNP) NT-proBNP (or BNP) measurements Baseline, 6, and 12 months post-implantation
Other (Randomized Arm) HFHs post- vs. pre-implantation The number of HFHs at 12 months post-implantation compared to the num ber of HFHs in the 12 months prior to implantation 12 months post-implantation
Other (Single Arm) EQ-5D-5L Health status as assessed by the EQ-5D-5L Questionnaire Baseline, 6, and 12 months post-implantation
Other (Single Arm) KCCQ-12 Health status as assessed by the KCCQ-12 Baseline, 6, and 12 months post-implantation
Other (Single Arm) 6MHW Test 6MHW Test Distance Baseline, 6, and 12 months post-implantation
Other (Single Arm) Cardiovascular mortality The number of deaths of cardiovascular cause 12 months post-implantation
Other (Single Arm) All-cause hospitalizations The number of hospitalizations of any cause 12 months post-implantation
Other (Single Arm) Frequency of subject PA pressure uploads The frequency of subject uploads of PA pressure 12 months post-implantation
Other (Single Arm) Frequency of clinician review of subject PA pressure uploads The frequency of clinician review of subject uploads of PA pressure 12 months post-implantation
Other (Single Arm) HF medication changes The number of changes in HF medications 12 months post-implantation
Other (Single Arm) PA pressure measurements PA pressure measurements Baseline through 12 months post-implantation
Other (Single Arm) NT-proBNP (or BNP) NT-proBNP (or BNP) measurements Baseline, 6, and 12 months post-implantation
Primary (Randomized Arm) Composite outcome of (1) HFHs, (2) intravenous diuretic visits, and (3) all-cause mortality The composite of:
The number of recurrent HFHs
The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
The number of deaths of any cause
added together with equal weighting into a total number of events
12 months post-implantation
Primary (Single Arm) Composite outcome of (1) HFHs, (2) intravenous diuretic visits, and (3) all-cause mortality The composite outcome of:
The number of recurrent HFHs
The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
The number of deaths of any cause
added together with equal weighting into a total number of events
12 months post-implantation
Secondary (Randomized Arm) Composite outcome of (1) HFHs and (2) intravenous diuretic visits The composite outcome of:
The number of recurrent HFHs
The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
added together with equal weighting into a total number of events
12 months post-implantation
Secondary (Randomized Arm) EQ-5D-5L Health status as assessed by the EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Questionnaire Baseline, 6, and 12 months post-implantation
Secondary (Randomized Arm) KCCQ-12 Health status as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Baseline, 6, and 12 months post-implantation
Secondary (Randomized Arm) 6MHW Test Six Minute Hall Walk (6MHW) Test Distance Baseline, 6, and 12 months post-implantation
Secondary (Randomized Arm) HFHs The number of recurrent HFHs 12 months post-implantation
Secondary (Randomized Arm) Intravenous diuretic visits The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy 12 months post-implantation
Secondary (Randomized Arm) All-cause mortality The number of deaths of any cause 12 months post-implantation
Secondary (Randomized Arm) Safety: Freedom from DSRCs Freedom from device/system related complications (DSRCs) 12 months post-implantation
Secondary (Single Arm) Composite outcome of (1) HFHs and (2) intravenous diuretic visits The composite outcome of:
The number of recurrent HFHs
The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
added together with equal weighting into a total number of events
12 months post-implantation
Secondary (Single Arm) HFHs post- vs. pre-implantation The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation 12 months post-implantation
Secondary (Single Arm) HFHs The number of HFHs 12 months post-implantation
Secondary (Single Arm) Intravenous diuretic visits The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy 12 months post-implantation
Secondary (Single Arm) All-cause mortality The number of deaths of any cause 12 months post-implantation
Secondary (Single Arm) Safety: Freedom from DSRCs Freedom from DSRCs 12 months post-implantation
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