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

Primary Purpose

Heart Failure, Heart Failure, Systolic, Heart Failure, Diastolic

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CardioMEMS™ HF System
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Hemodynamic Monitoring, CardioMEMS, Pulmonary Artery Pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Banner-University Medical Center Phoenix
  • Arizona Cardiovascular Research Center
  • Phoenix Cardiovascular Research Group
  • University of Arizona
  • Washington Regional Medical Center
  • Baptist Health Medical Center
  • Arkansas Heart Hospital
  • John Muir Medical Center
  • Adventist Health St. Helena
  • Scripps Health
  • University of California at San Diego (UCSD) Medical Center
  • USC University Hospital
  • Ronald Reagan UCLA Medical Center
  • Eisenhower Medical Center
  • Sutter Medical Center, Sacramento
  • Mercy Medical Group - Cardiology
  • San Diego Cardiac Center
  • California Pacific Medical Center - Van Ness Campus
  • Ventura Cardiology Consultants
  • University of Colorado Hospital
  • North Colorado Medical Center
  • South Denver Cardiology Associates PC
  • Hartford Hospital
  • Yale New Haven Hospital
  • George Washington University Hospital
  • Bethesda Memorial Hospital
  • Morton Plant Hospital
  • Memorial Regional Hospital
  • First Coast Cardiovascular Institute
  • Memorial Hospital Jacksonville
  • Mercy Hospital
  • Advent Health Orlando
  • Orlando Regional Medical Center
  • Tampa General Hospital
  • Piedmont Athens Regional Medical Center
  • University Hospital
  • WellStar Kennestone Hospital
  • Northshore University HealthSystem
  • Midwest Cardiovascular Institute
  • Advocate Health and Hospitals Corporation
  • St. Vincent Hospital
  • Heart Center of Lake County
  • Iowa Heart Center
  • Kansas University Medical Center
  • Cardiovascular Research Institute of Kansas
  • Our Lady of the Lake Hospital
  • Cardiovascular Institute of the South
  • Louisiana State University Health Sciences Center
  • Ochsner Medical Center
  • Advanced Cardiovascular Specialists
  • Brigham and Women's Hospital
  • University of Massachusetts
  • University of Michigan
  • McLaren Health Care Corporation
  • Henry Ford Hospital
  • Sparrow Clinical Research Institute
  • MidMichigan Medical Center-Midland
  • Providence Hospital
  • Minneapolis Heart Institute
  • University of Minnesota Medical Center Fairview
  • Mayo Clinic
  • St. Cloud Hospital
  • St. Luke's Hospital
  • North Kansas City Hospital
  • Mercy Hospital St. Louis
  • BryanLGH Heart Institute
  • University of Nebraska Medical Center
  • Renown Regional Medical Center
  • Catholic Medical Center
  • Deborah Heart and Lung Center
  • Hackensack University Medical Center
  • Saint Barnabas Medical Center
  • Lourdes Cardiology Services
  • New Mexico Heart Institute
  • New York University Hospital
  • Mount Sinai Hospital
  • New York-Presbyterian/Columbia University
  • Hudson Valley Cardiovascular Practice, P.C.
  • Rochester General Hospital
  • St. Francis Hospital
  • Carolinas Medical Center
  • Vidant Medical Center
  • NC Heart and Vascular Research
  • WakeMed Hospital
  • Akron City Hospital
  • University Hospitals Cleveland Medical Center
  • The Cleveland Clinic Foundation
  • Ohio State University
  • Ohio Health Research Institute
  • St. Elizabeth Health Center
  • Integris Baptist Medical Center
  • Oklahoma Heart Hospital South
  • Oklahoma Heart Institute at Utica
  • Providence Heart and Vascular
  • Abington Memorial Hospital
  • Pinnacle Health System
  • Penn State Milton S. Hershey Medical Center
  • Lancaster General Hospital
  • Hospital of the University of Pennsylvania
  • Albert Einstein Medical Center
  • Allegheny General Hospital - ASRI
  • The Reading Hospital and Medical Center
  • Main Line Health Center/Lankenau Hospital
  • Rhode Island Hospital
  • Prisma Health-Midlands
  • Greenville Health System
  • Sanford USD Medical Center
  • Tennova Healthcare - Turkey Creek Medical Center
  • Methodist University Hospital
  • St Thomas Hospital
  • Vanderbilt University Medical Center
  • Acension Texas Cardiovascular
  • Austin Heart
  • Baylor University Hospital
  • John Peter Smith Hospital
  • Park Plaza Hospital
  • CHI St. Luke's Health Baylor College of Medicine Med. Ctr.
  • Memorial Hermann Hospital
  • The Methodist Hospital
  • Methodist Healthcare System of San Antonio
  • Virginia Heart - The Cardiovascular Group, P.C.
  • Sentara Norfolk General Hospital
  • Bon Secours Heart & Vascular Institute
  • Winchester Medical Center
  • Providence Everett Medical Center
  • Swedish Medical Center - Heart & Vascular
  • University of Washington Medical Center
  • Aurora Medical Group
  • Waukesha Memorial Hospital
  • Aspirus Wausau Hospital
  • Foothills Medical Centre
  • Vancouver General Hospital (U of BC)
  • Southlake Regional Health Centre
  • Toronto General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Randomized Arm - Treatment Group

Randomized Arm - Control Group

Single Arm

Arm Description

Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System.

Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System.

Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System.

Outcomes

Primary Outcome Measures

(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
(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

Secondary Outcome Measures

(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
(Randomized Arm) EQ-5D-5L
Health status as assessed by the EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Questionnaire
(Randomized Arm) KCCQ-12
Health status as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
(Randomized Arm) 6MHW Test
Six Minute Hall Walk (6MHW) Test Distance
(Randomized Arm) HFHs
The number of recurrent HFHs
(Randomized Arm) Intravenous diuretic visits
The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
(Randomized Arm) All-cause mortality
The number of deaths of any cause
(Randomized Arm) Safety: Freedom from DSRCs
Freedom from device/system related complications (DSRCs)
(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
(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
(Single Arm) HFHs
The number of HFHs
(Single Arm) Intravenous diuretic visits
The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
(Single Arm) All-cause mortality
The number of deaths of any cause
(Single Arm) Safety: Freedom from DSRCs
Freedom from DSRCs

Full Information

First Posted
December 12, 2017
Last Updated
August 8, 2023
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT03387813
Brief Title
Hemodynamic-GUIDEd Management of Heart Failure
Acronym
GUIDE-HF
Official Title
Hemodynamic-GUIDEd Management of Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
May 17, 2023 (Actual)
Study Completion Date
May 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Heart Failure, Hemodynamic Monitoring, CardioMEMS, Pulmonary Artery Pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2358 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Randomized Arm - Treatment Group
Arm Type
Experimental
Arm Description
Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System.
Arm Title
Randomized Arm - Control Group
Arm Type
Experimental
Arm Description
Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System.
Arm Title
Single Arm
Arm Type
Experimental
Arm Description
Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System.
Intervention Type
Device
Intervention Name(s)
CardioMEMS™ HF System
Other Intervention Name(s)
CardioMEMS, CardioMEMS PA Sensor, CardioMEMS HF System
Intervention Description
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.
Primary Outcome Measure Information:
Title
(Randomized Arm) Composite outcome of (1) HFHs, (2) intravenous diuretic visits, and (3) all-cause mortality
Description
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
Time Frame
12 months post-implantation
Title
(Single Arm) Composite outcome of (1) HFHs, (2) intravenous diuretic visits, and (3) all-cause mortality
Description
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
Time Frame
12 months post-implantation
Secondary Outcome Measure Information:
Title
(Randomized Arm) Composite outcome of (1) HFHs and (2) intravenous diuretic visits
Description
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
Time Frame
12 months post-implantation
Title
(Randomized Arm) EQ-5D-5L
Description
Health status as assessed by the EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Questionnaire
Time Frame
Baseline, 6, and 12 months post-implantation
Title
(Randomized Arm) KCCQ-12
Description
Health status as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Time Frame
Baseline, 6, and 12 months post-implantation
Title
(Randomized Arm) 6MHW Test
Description
Six Minute Hall Walk (6MHW) Test Distance
Time Frame
Baseline, 6, and 12 months post-implantation
Title
(Randomized Arm) HFHs
Description
The number of recurrent HFHs
Time Frame
12 months post-implantation
Title
(Randomized Arm) Intravenous diuretic visits
Description
The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
Time Frame
12 months post-implantation
Title
(Randomized Arm) All-cause mortality
Description
The number of deaths of any cause
Time Frame
12 months post-implantation
Title
(Randomized Arm) Safety: Freedom from DSRCs
Description
Freedom from device/system related complications (DSRCs)
Time Frame
12 months post-implantation
Title
(Single Arm) Composite outcome of (1) HFHs and (2) intravenous diuretic visits
Description
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
Time Frame
12 months post-implantation
Title
(Single Arm) HFHs post- vs. pre-implantation
Description
The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation
Time Frame
12 months post-implantation
Title
(Single Arm) HFHs
Description
The number of HFHs
Time Frame
12 months post-implantation
Title
(Single Arm) Intravenous diuretic visits
Description
The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
Time Frame
12 months post-implantation
Title
(Single Arm) All-cause mortality
Description
The number of deaths of any cause
Time Frame
12 months post-implantation
Title
(Single Arm) Safety: Freedom from DSRCs
Description
Freedom from DSRCs
Time Frame
12 months post-implantation
Other Pre-specified Outcome Measures:
Title
(Randomized Arm) Cardiovascular mortality
Description
The number of deaths with cardiovascular cause
Time Frame
12 months post-implantation
Title
(Randomized Arm) All-cause hospitalizations
Description
The number of hospitalizations of any cause
Time Frame
12 months post-implantation
Title
(Randomized Arm) Frequency of subject PA pressure uploads
Description
The frequency of subject uploads of PA pressure
Time Frame
12 months post-implantation
Title
(Randomized Arm) Frequency of clinician review of subject PA pressure uploads
Description
The frequency of clinician review of subject uploads of PA pressure
Time Frame
12 months post-implantation
Title
(Randomized Arm) HF medication changes
Description
The number of changes in HF medications
Time Frame
12 months post-implantation
Title
(Randomized Arm) PA pressure measurements
Description
PA pressure measurements
Time Frame
Baseline through 12 months post-implantation
Title
(Randomized Arm) NT-proBNP (or BNP)
Description
NT-proBNP (or BNP) measurements
Time Frame
Baseline, 6, and 12 months post-implantation
Title
(Randomized Arm) HFHs post- vs. pre-implantation
Description
The number of HFHs at 12 months post-implantation compared to the num ber of HFHs in the 12 months prior to implantation
Time Frame
12 months post-implantation
Title
(Single Arm) EQ-5D-5L
Description
Health status as assessed by the EQ-5D-5L Questionnaire
Time Frame
Baseline, 6, and 12 months post-implantation
Title
(Single Arm) KCCQ-12
Description
Health status as assessed by the KCCQ-12
Time Frame
Baseline, 6, and 12 months post-implantation
Title
(Single Arm) 6MHW Test
Description
6MHW Test Distance
Time Frame
Baseline, 6, and 12 months post-implantation
Title
(Single Arm) Cardiovascular mortality
Description
The number of deaths of cardiovascular cause
Time Frame
12 months post-implantation
Title
(Single Arm) All-cause hospitalizations
Description
The number of hospitalizations of any cause
Time Frame
12 months post-implantation
Title
(Single Arm) Frequency of subject PA pressure uploads
Description
The frequency of subject uploads of PA pressure
Time Frame
12 months post-implantation
Title
(Single Arm) Frequency of clinician review of subject PA pressure uploads
Description
The frequency of clinician review of subject uploads of PA pressure
Time Frame
12 months post-implantation
Title
(Single Arm) HF medication changes
Description
The number of changes in HF medications
Time Frame
12 months post-implantation
Title
(Single Arm) PA pressure measurements
Description
PA pressure measurements
Time Frame
Baseline through 12 months post-implantation
Title
(Single Arm) NT-proBNP (or BNP)
Description
NT-proBNP (or BNP) measurements
Time Frame
Baseline, 6, and 12 months post-implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nessa Johnson, PhD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Banner-University Medical Center Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Arizona Cardiovascular Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Phoenix Cardiovascular Research Group
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
Washington Regional Medical Center
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Baptist Health Medical Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Arkansas Heart Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
John Muir Medical Center
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Adventist Health St. Helena
City
Deer Park
State/Province
California
ZIP/Postal Code
94574
Country
United States
Facility Name
Scripps Health
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of California at San Diego (UCSD) Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
USC University Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Eisenhower Medical Center
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Sutter Medical Center, Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Mercy Medical Group - Cardiology
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
San Diego Cardiac Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
California Pacific Medical Center - Van Ness Campus
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Ventura Cardiology Consultants
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
North Colorado Medical Center
City
Greeley
State/Province
Colorado
ZIP/Postal Code
80631
Country
United States
Facility Name
South Denver Cardiology Associates PC
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
George Washington University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Bethesda Memorial Hospital
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33466
Country
United States
Facility Name
Morton Plant Hospital
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33020
Country
United States
Facility Name
First Coast Cardiovascular Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Memorial Hospital Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Mercy Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Advent Health Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Orlando Regional Medical Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Piedmont Athens Regional Medical Center
City
Athens
State/Province
Georgia
ZIP/Postal Code
30606
Country
United States
Facility Name
University Hospital
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
WellStar Kennestone Hospital
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Northshore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Midwest Cardiovascular Institute
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Facility Name
Advocate Health and Hospitals Corporation
City
Oakbrook Terrace
State/Province
Illinois
ZIP/Postal Code
60181
Country
United States
Facility Name
St. Vincent Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46240
Country
United States
Facility Name
Heart Center of Lake County
City
Merrillville
State/Province
Indiana
ZIP/Postal Code
46410
Country
United States
Facility Name
Iowa Heart Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Kansas University Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Cardiovascular Research Institute of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
Our Lady of the Lake Hospital
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Cardiovascular Institute of the South
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70361
Country
United States
Facility Name
Louisiana State University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Advanced Cardiovascular Specialists
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
McLaren Health Care Corporation
City
Auburn Hills
State/Province
Michigan
ZIP/Postal Code
48326
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Sparrow Clinical Research Institute
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
MidMichigan Medical Center-Midland
City
Midland
State/Province
Michigan
ZIP/Postal Code
48640
Country
United States
Facility Name
Providence Hospital
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Minneapolis Heart Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
University of Minnesota Medical Center Fairview
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
St. Cloud Hospital
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
St. Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
North Kansas City Hospital
City
North Kansas City
State/Province
Missouri
ZIP/Postal Code
64116
Country
United States
Facility Name
Mercy Hospital St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
BryanLGH Heart Institute
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Renown Regional Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Catholic Medical Center
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03102
Country
United States
Facility Name
Deborah Heart and Lung Center
City
Browns Mills
State/Province
New Jersey
ZIP/Postal Code
08015
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Saint Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
Lourdes Cardiology Services
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
New Mexico Heart Institute
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
New York University Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
New York-Presbyterian/Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Hudson Valley Cardiovascular Practice, P.C.
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Rochester General Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Facility Name
St. Francis Hospital
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Vidant Medical Center
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27835
Country
United States
Facility Name
NC Heart and Vascular Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
WakeMed Hospital
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Akron City Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44309
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Ohio Health Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
St. Elizabeth Health Center
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44501
Country
United States
Facility Name
Integris Baptist Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Oklahoma Heart Hospital South
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73135
Country
United States
Facility Name
Oklahoma Heart Institute at Utica
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Facility Name
Providence Heart and Vascular
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Pinnacle Health System
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17105
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17603
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Albert Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Allegheny General Hospital - ASRI
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
The Reading Hospital and Medical Center
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Main Line Health Center/Lankenau Hospital
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Prisma Health-Midlands
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Greenville Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Sanford USD Medical Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117
Country
United States
Facility Name
Tennova Healthcare - Turkey Creek Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Methodist University Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
St Thomas Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Acension Texas Cardiovascular
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Austin Heart
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Baylor University Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
John Peter Smith Hospital
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Park Plaza Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
CHI St. Luke's Health Baylor College of Medicine Med. Ctr.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Methodist Healthcare System of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Virginia Heart - The Cardiovascular Group, P.C.
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Bon Secours Heart & Vascular Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Winchester Medical Center
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Providence Everett Medical Center
City
Everett
State/Province
Washington
ZIP/Postal Code
98206
Country
United States
Facility Name
Swedish Medical Center - Heart & Vascular
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Aurora Medical Group
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Waukesha Memorial Hospital
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Facility Name
Aspirus Wausau Hospital
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N2T9
Country
Canada
Facility Name
Vancouver General Hospital (U of BC)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Southlake Regional Health Centre
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P9
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35266003
Citation
Zile MR, Desai AS, Costanzo MR, Ducharme A, Maisel A, Mehra MR, Paul S, Sears SF, Smart F, Chien C, Guha A, Guichard JL, Hall S, Jonsson O, Johnson N, Sood P, Henderson J, Adamson PB, Lindenfeld J. The GUIDE-HF trial of pulmonary artery pressure monitoring in heart failure: impact of the COVID-19 pandemic. Eur Heart J. 2022 Jul 14;43(27):2603-2618. doi: 10.1093/eurheartj/ehac114.
Results Reference
derived
PubMed Identifier
34461042
Citation
Lindenfeld J, Zile MR, Desai AS, Bhatt K, Ducharme A, Horstmanshof D, Krim SR, Maisel A, Mehra MR, Paul S, Sears SF, Sauer AJ, Smart F, Zughaib M, Castaneda P, Kelly J, Johnson N, Sood P, Ginn G, Henderson J, Adamson PB, Costanzo MR. Haemodynamic-guided management of heart failure (GUIDE-HF): a randomised controlled trial. Lancet. 2021 Sep 11;398(10304):991-1001. doi: 10.1016/S0140-6736(21)01754-2. Epub 2021 Aug 27.
Results Reference
derived

Learn more about this trial

Hemodynamic-GUIDEd Management of Heart Failure

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