Hemodynamic-GUIDEd Management of Heart Failure



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/3/2019
Start Date:March 15, 2018
End Date:April 2023
Contact:Rebecca Apruzzese
Email:rebecca.apruzzese@abbott.com
Phone:818-493-4210

Use our guide to learn which trials are right for you!

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.

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.

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
We found this trial at
61
sites
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Sandip Zalawadiya, MD
Phone: 615-343-4841
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Principal Investigator: Donald Haas, MD
Phone: 215-481-4661
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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Abington, PA
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1199 Prince Avenue
Athens, Georgia 30606
Principal Investigator: Catherine Marti, MD
Phone: 706-475-1828
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Athens, GA
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Principal Investigator: Divya Gupta, MD
Phone: 404-712-0502
Emory University Hospital As the largest health care system in Georgia and the only health...
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2701 Cambridge Court
Auburn Hills, Michigan 48326
Principal Investigator: Kalil Masri, MD
Phone: 989-894-3290
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Austin, Texas 78756
Principal Investigator: Kunjan Bhatt, MD
Phone: 512-206-3603
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Austin, Texas 78705
Principal Investigator: Ernest Haeusslein, MD
Phone: 512-324-3434
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Baton Rouge, Louisiana 70808
Principal Investigator: David Moll, MD
Phone: 225-765-7659
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Cleveland, Ohio 44012
Principal Investigator: Monique Robinson, MD
Phone: 216-983-4724
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Columbus, Ohio 43214
Principal Investigator: Anupam Basuray, MD
Phone: 614-566-1262
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Brent Lampert, MD
Phone: 614-292-4084
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Concord, California 94520
Principal Investigator: Neal White, MD
Phone: 925-674-2287
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3500 Gaston Avenue
Dallas, Texas 75246
Principal Investigator: Shelley Hall, MD
Phone: 254-724-5373
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Fayetteville, Arkansas 72703
Principal Investigator: Joel Carver, MD
Phone: 479-463-7856
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Fort Pierce, Florida 34950
Principal Investigator: Prasad Chalasani, MD
Phone: 772-465-4499
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Greenville, North Carolina 27834
Principal Investigator: Hassan Alhosaini, MD
Phone: 252-847-0162
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Harrisburg, Pennsylvania 17101
Principal Investigator: Roberto Hodara, MD
Phone: 717-920-4400
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Principal Investigator: John Boehmer, MD
Phone: 717-531-6855
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Houston, Texas 77030
Principal Investigator: Sachin Kumar, MD
Phone: 713-486-6751
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Houston, Texas 77030
Principal Investigator: Arvind Bhimaraj, MD, MPH
Phone: 713-441-3916
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Indianapolis, Indiana
Principal Investigator: Ashwin Ravichandran, MD
Phone: 317-338-6161
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Jacksonville, Florida 32216
Principal Investigator: Sumant Lamba, MD
Phone: 612-329-7274
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Jacksonville, Florida 32216
Principal Investigator: Omer Zuberi, MD
Phone: 904-493-3333
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Kansas City, Kansas
Principal Investigator: Andrew Sauer, MD
Phone: 913-588-9722
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Knoxville, Tennessee 37934
Principal Investigator: Malcolm Foster, MD
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La Jolla, California 92037
Principal Investigator: James Heywood, MD
Phone: 858-824-5247
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555 N Duke St
Lancaster, Pennsylvania 17602
(717) 544-5511
Principal Investigator: Tareck Nossuli, MD, PhD
Phone: 717-544-1777
Lancaster General Hospital For more than a century, Lancaster General Hospital has been a leader...
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Lexington, Kentucky
859) 257-9000
Principal Investigator: Maya Guglin, MD PhD
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Lincoln, Nebraska 68506
Principal Investigator: John Steuter, MD
Phone: 402-483-3290
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Little Rock, Arkansas 72211
Principal Investigator: Scott Beau, MD
Phone: 501-748-8425
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Littleton, Colorado 80120
Principal Investigator: Ira Dauber, MD
Phone: 303-703-2191
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94 Old Short Hills Road
Livingston, New Jersey 07039
(973) 322-5000
Principal Investigator: Mark Zucker, MD
Phone: 973-429-8333
Saint Barnabas Medical Center As a Barnabas Health facility, Saint Barnabas Medical Center is committed...
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Los Angeles, California 90033
Principal Investigator: Luanda Grazette, MD
Phone: 323-442-7983
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Manchester, New Hampshire 03102
Principal Investigator: Robert Capodilupo, MD
Phone: 603-665-2443
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Merrillville, Indiana 46410
Principal Investigator: Andre Artis, MD
Phone: 219-884-9180
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Milwaukee, Wisconsin 14450
Principal Investigator: Nasir Sulemanjee, MD
Phone: 414-385-2432
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Minneapolis, Minnesota 55407
Principal Investigator: Mosi Bennett, MD, PhD
Phone: 612-863-7493
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Nashville, Tennessee 37205
Principal Investigator: Mark Aaron, MD
Phone: 615-222-3136
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1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
Principal Investigator: Selim Krim, MD
Phone: 504-842-5257
Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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New Orleans, Louisiana 70112
Principal Investigator: Murtuza Ali, MD
Phone: 504-568-2349
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622 West 168th Street
New York, New York 10032
Principal Investigator: Kelly Axsom, MD
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Oakbrook Terrace, Illinois 60181
Principal Investigator: Maria Rosa Costanzo, MD
Phone: 630-785-2671
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Oklahoma City, Oklahoma
Principal Investigator: Douglas Horstmanshof, MD
Phone: 405-951-8213
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Principal Investigator: Nirav Raval, MD
Phone: 407-303-7556
Florida Hospital Florida Hospital is one of the country
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Pittsburgh, Pennsylvania 15212
Principal Investigator: Raymond Benza, MD
Phone: 412-359-3293
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Portland, Oregon 97225
Principal Investigator: Jacob Abraham, MD
Phone: 503-216-2110
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Poughkeepsie, New York 12601
Principal Investigator: James Lyons, MD
Phone: 845-473-1188
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Raleigh, North Carolina 27610
Principal Investigator: Christopher Chien, MD, FACC
Phone: 919-784-4031
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Rancho Mirage, California 92270
Principal Investigator: Leon Feldman, MD
Phone: 760-346-0642
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Roslyn, New York 11576
Principal Investigator: Rita Jermyn, MD
Phone: 516-622-4528
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Sacramento, California 95816
Principal Investigator: Munir Janmohamed, MD
Phone: 916-453-4947
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1406 6th Avenue North
Saint Cloud, Minnesota 56303
Principal Investigator: Jamie Pelzel, MD
Phone: 320-251-2700
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San Diego, California 92123
Principal Investigator: Brian Jaski, MD
Phone: 858-244-6886
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550 17th Avenue
Seattle, Washington 98122
Principal Investigator: Terrie-Ann Benjamin, MD
Phone: 206-215-2455
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Sioux Falls, South Dakota 57117
Principal Investigator: Orvar Jonsson, MD
Phone: 605-312-2271
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16001 W 9 Mile Rd
Southfield, Michigan 48075
(248) 849-3000
Principal Investigator: Marcel Zughaib, MD
Phone: 248-465-4828
Providence Hospital St. John Providence Health System is comprised of five hospitals plus more than...
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Tucson, Arizona 85721
(520) 621-2211
Principal Investigator: Jennifer Cook, MD, FAHA
Phone: 520-626-4899
University of Arizona The University of Arizona is a premier, public research university. Established in...
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Ventura, California 93003
Principal Investigator: Thomas Kong, MD
Phone: 805-648-2763
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Wausau, Wisconsin 54401
Principal Investigator: German Larrain, MD
Phone: 715-847-2273
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West Reading, Pennsylvania 19612
Principal Investigator: Jared Green, DO
Phone: 484-628-4317
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Wynnewood, Pennsylvania 19096
Principal Investigator: Christopher Droogan, DO
Phone: 484-476-2021
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