Heart Failure Clinical Trial

Hemodynamic-GUIDEd Management of Heart Failure

Summary

The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMSâ„¢ 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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

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), 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

Study is for people with:

Heart Failure

Estimated Enrollment:

2358

Study ID:

NCT03387813

Recruitment Status:

Completed

Sponsor:

Abbott Medical Devices

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There are 130 Locations for this study

See Locations Near You

Banner-University Medical Center Phoenix
Phoenix Arizona, 85006, United States
Arizona Cardiovascular Research Center
Phoenix Arizona, 85016, United States
Phoenix Cardiovascular Research Group
Phoenix Arizona, 85018, United States
University of Arizona
Tucson Arizona, 85719, United States
Washington Regional Medical Center
Fayetteville Arkansas, 72703, United States
Baptist Health Medical Center
Little Rock Arkansas, 72205, United States
Arkansas Heart Hospital
Little Rock Arkansas, 72211, United States
John Muir Medical Center
Concord California, 94520, United States
Adventist Health St. Helena
Deer Park California, 94574, United States
Scripps Health
La Jolla California, 92037, United States
University of California at San Diego (UCSD) Medical Center
La Jolla California, 92037, United States
USC University Hospital
Los Angeles California, 90033, United States
Ronald Reagan UCLA Medical Center
Los Angeles California, 90095, United States
Eisenhower Medical Center
Rancho Mirage California, 92270, United States
Sutter Medical Center, Sacramento
Sacramento California, 95816, United States
Mercy Medical Group - Cardiology
Sacramento California, 95819, United States
San Diego Cardiac Center
San Diego California, 92123, United States
California Pacific Medical Center - Van Ness Campus
San Francisco California, 94109, United States
Ventura Cardiology Consultants
Ventura California, 93003, United States
University of Colorado Hospital
Aurora Colorado, 80045, United States
North Colorado Medical Center
Greeley Colorado, 80631, United States
South Denver Cardiology Associates PC
Littleton Colorado, 80120, United States
Hartford Hospital
Hartford Connecticut, 06106, United States
Yale New Haven Hospital
New Haven Connecticut, 06510, United States
George Washington University Hospital
Washington District of Columbia, 20037, United States
Bethesda Memorial Hospital
Boynton Beach Florida, 33466, United States
Morton Plant Hospital
Clearwater Florida, 33756, United States
Memorial Regional Hospital
Hollywood Florida, 33020, United States
First Coast Cardiovascular Institute
Jacksonville Florida, 32216, United States
Memorial Hospital Jacksonville
Jacksonville Florida, 32216, United States
Mercy Hospital
Miami Florida, 33133, United States
Advent Health Orlando
Orlando Florida, 32803, United States
Orlando Regional Medical Center
Orlando Florida, 32806, United States
Tampa General Hospital
Tampa Florida, 33606, United States
Piedmont Athens Regional Medical Center
Athens Georgia, 30606, United States
University Hospital
Augusta Georgia, 30901, United States
WellStar Kennestone Hospital
Marietta Georgia, 30060, United States
Northshore University HealthSystem
Evanston Illinois, 60201, United States
Midwest Cardiovascular Institute
Naperville Illinois, 60540, United States
Advocate Health and Hospitals Corporation
Oakbrook Terrace Illinois, 60181, United States
St. Vincent Hospital
Indianapolis Indiana, 46240, United States
Heart Center of Lake County
Merrillville Indiana, 46410, United States
Iowa Heart Center
West Des Moines Iowa, 50266, United States
Kansas University Medical Center
Kansas City Kansas, 66160, United States
Cardiovascular Research Institute of Kansas
Wichita Kansas, 67226, United States
Our Lady of the Lake Hospital
Baton Rouge Louisiana, 70808, United States
Cardiovascular Institute of the South
Houma Louisiana, 70361, United States
Louisiana State University Health Sciences Center
New Orleans Louisiana, 70112, United States
Ochsner Medical Center
New Orleans Louisiana, 70121, United States
Advanced Cardiovascular Specialists
Shreveport Louisiana, 71105, United States
Brigham and Women's Hospital
Boston Massachusetts, 02115, United States
University of Massachusetts
Worcester Massachusetts, 01655, United States
University of Michigan
Ann Arbor Michigan, 48104, United States
McLaren Health Care Corporation
Auburn Hills Michigan, 48326, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Sparrow Clinical Research Institute
Lansing Michigan, 48912, United States
MidMichigan Medical Center-Midland
Midland Michigan, 48640, United States
Providence Hospital
Southfield Michigan, 48075, United States
Minneapolis Heart Institute
Minneapolis Minnesota, 55407, United States
University of Minnesota Medical Center Fairview
Minneapolis Minnesota, 55455, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
St. Cloud Hospital
Saint Cloud Minnesota, 56303, United States
St. Luke's Hospital
Kansas City Missouri, 64111, United States
North Kansas City Hospital
North Kansas City Missouri, 64116, United States
Mercy Hospital St. Louis
Saint Louis Missouri, 63141, United States
BryanLGH Heart Institute
Lincoln Nebraska, 68506, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
Renown Regional Medical Center
Reno Nevada, 89502, United States
Catholic Medical Center
Manchester New Hampshire, 03102, United States
Deborah Heart and Lung Center
Browns Mills New Jersey, 08015, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Saint Barnabas Medical Center
Livingston New Jersey, 07039, United States
Lourdes Cardiology Services
Voorhees New Jersey, 08043, United States
New Mexico Heart Institute
Albuquerque New Mexico, 87102, United States
New York University Hospital
New York New York, 10016, United States
Mount Sinai Hospital
New York New York, 10019, United States
New York-Presbyterian/Columbia University
New York New York, 10032, United States
Hudson Valley Cardiovascular Practice, P.C.
Poughkeepsie New York, 12601, United States
Rochester General Hospital
Rochester New York, 14621, United States
St. Francis Hospital
Roslyn New York, 11576, United States
Carolinas Medical Center
Charlotte North Carolina, 28203, United States
Vidant Medical Center
Greenville North Carolina, 27835, United States
NC Heart and Vascular Research
Raleigh North Carolina, 27607, United States
WakeMed Hospital
Raleigh North Carolina, 27610, United States
Akron City Hospital
Akron Ohio, 44309, United States
University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States
The Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
Ohio State University
Columbus Ohio, 43210, United States
Ohio Health Research Institute
Columbus Ohio, 43214, United States
St. Elizabeth Health Center
Youngstown Ohio, 44501, United States
Integris Baptist Medical Center
Oklahoma City Oklahoma, 73112, United States
Oklahoma Heart Hospital South
Oklahoma City Oklahoma, 73135, United States
Oklahoma Heart Institute at Utica
Tulsa Oklahoma, 74133, United States
Providence Heart and Vascular
Portland Oregon, 97225, United States
Abington Memorial Hospital
Abington Pennsylvania, 19001, United States
Pinnacle Health System
Harrisburg Pennsylvania, 17105, United States
Penn State Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Lancaster General Hospital
Lancaster Pennsylvania, 17603, United States
Hospital of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Albert Einstein Medical Center
Philadelphia Pennsylvania, 19141, United States
Allegheny General Hospital - ASRI
Pittsburgh Pennsylvania, 15212, United States
The Reading Hospital and Medical Center
West Reading Pennsylvania, 19611, United States
Main Line Health Center/Lankenau Hospital
Wynnewood Pennsylvania, 19096, United States
Rhode Island Hospital
Providence Rhode Island, 02903, United States
Prisma Health-Midlands
Columbia South Carolina, 29203, United States
Greenville Health System
Greenville South Carolina, 29605, United States
Sanford USD Medical Center
Sioux Falls South Dakota, 57117, United States
Tennova Healthcare - Turkey Creek Medical Center
Knoxville Tennessee, 37920, United States
Methodist University Hospital
Memphis Tennessee, 38104, United States
St Thomas Hospital
Nashville Tennessee, 37205, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
Acension Texas Cardiovascular
Austin Texas, 78705, United States
Austin Heart
Austin Texas, 78756, United States
Baylor University Hospital
Dallas Texas, 75246, United States
John Peter Smith Hospital
Fort Worth Texas, 76104, United States
Park Plaza Hospital
Houston Texas, 77004, United States
CHI St. Luke's Health Baylor College of Medicine Med. Ctr.
Houston Texas, 77030, United States
Memorial Hermann Hospital
Houston Texas, 77030, United States
The Methodist Hospital
Houston Texas, 77030, United States
Methodist Healthcare System of San Antonio
San Antonio Texas, 78229, United States
Virginia Heart - The Cardiovascular Group, P.C.
Falls Church Virginia, 22042, United States
Sentara Norfolk General Hospital
Norfolk Virginia, 23507, United States
Bon Secours Heart & Vascular Institute
Richmond Virginia, 23226, United States
Winchester Medical Center
Winchester Virginia, 22601, United States
Providence Everett Medical Center
Everett Washington, 98206, United States
Swedish Medical Center - Heart & Vascular
Seattle Washington, 98122, United States
University of Washington Medical Center
Seattle Washington, 98195, United States
Aurora Medical Group
Milwaukee Wisconsin, 53215, United States
Waukesha Memorial Hospital
Waukesha Wisconsin, 53188, United States
Aspirus Wausau Hospital
Wausau Wisconsin, 54401, United States
Foothills Medical Centre
Calgary Alberta, T2N2T, Canada
Vancouver General Hospital (U of BC)
Vancouver British Columbia, V5Z 1, Canada
Southlake Regional Health Centre
Newmarket Ontario, L3Y 2, Canada
Toronto General Hospital
Toronto Ontario, M5G 2, Canada

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

2358

Study ID:

NCT03387813

Recruitment Status:

Completed

Sponsor:


Abbott Medical Devices

How clear is this clinincal trial information?

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