Investigation to Optimize Hemodynamic Management of Left Ventricular Assist Devices Using the CardioMEMS™



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/3/2019
Start Date:August 17, 2017
End Date:September 30, 2019
Contact:Stella Osuji
Email:stella.osuji@abbott.com
Phone:972-526-9644

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Investigation to Optimize Hemodynamic Management of HeartMate II™ Left Ventricular Assist Device Patients Using the CardioMEMS™ Pulmonary Artery Pressure Sensor in Advanced Heart Failure

This observational post market study is intended to characterize hemodynamic-guided
management of patients with an existing left ventricular assist device (LVAD) to protocol
specified target ranges and its impact on functional status, quality of life, and
readmissions

The study is an observational, single group study where all participants receive the same
intervention. The study plans to enroll up to 100 patients at 25 US sites. All patients will
have a HeartMate Left Ventricular Assist Device (LVAD) and a CardioMEMS device implanted as
standard of care. After enrollment into the study, the patient will be followed until six
month follow up completion. The objective of this clinical investigation is to understand the
role of hemodynamic monitoring in LVAD patients and:

- Characterize PA pressure measurements with the CardioMEMS HF System in LVAD patients
under different clinical and physiologic conditions

- Characterize the effects of PA pressure on functional status, quality of life, and
hospital readmissions of LVAD patients

- Evaluate target ranges for PA pressure and assess the impact of medication and pump
speed changes on PA pressures

Inclusion Criteria:

1. Subject has CardioMEMS HF PA Sensor and a commercially-approved HeartMate LVAD (Group
A) OR Subject has commercially-approved HeartMate LVAD, is experiencing NYHA class III
symptoms, and has had a previous HF hospitalization and meets FDA indications for
CardioMEMS. The CardioMEMS sensor must be implanted within 72 hours of consent (Group
B)

2. Signed an informed consent form and agreed to provide access to patient and device
data (including CardioMEMS Merlin.net data)

3. No connectivity or transmission problems with CardioMEMS

4. On HeartMate LVAD support for at least 3 months

5. Age ≥ 18 years

Exclusion Criteria:

1. Current participation in an investigation that is likely to confound study results or
affect study outcome

2. Current participation in the MOMENTUM3 IDE Clinical trial and has not completed the
two year follow-up for that trial

3. Inability to perform 6MHW test due to conditions other than heart failure (e.g. severe
arthritis, orthopedic issues, amputation etc.)
We found this trial at
15
sites
4242 Dewey Ave
Omaha, Nebraska 68105
(800) 922-0000
Principal Investigator: Adam Burdorf, MD
Phone: 402-559-5127
Nebraska Medical Center Formed in 1997 by combining the operations of University Hospital, Bishop Clarkson...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Jay Bhama, MD
Phone: 319-353-5236
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Rebecca Cogswell, MD
Phone: 612-625-0920
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Columbus, Ohio 43210
Principal Investigator: Sitaramesh Emani, MD
Phone: 614-688-5506
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Columbus, OH
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Houston, Texas 77030
Principal Investigator: Arvind Bhimaraj, MD
Phone: 713-441-9837
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La Jolla, California 92037
Principal Investigator: Thomas Heywood, MD
Phone: 858-216-7370
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La Jolla, CA
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Lexington, Kentucky
859) 257-9000
Principal Investigator: Maya Guglin, MD
Phone: 859-323-8663
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Los Angeles, California 90033
Principal Investigator: Andrew Yoon, MD
Phone: 323-442-7283
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Los Angeles, CA
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Los Angeles, California 90095
Principal Investigator: Ali Nsair, MD
Phone: 301-794-4794
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2900 West Oklahoma Avenue
Milwaukee, Wisconsin 53215
Principal Investigator: Nasir Sulemanjee, MD
Phone: 414-385-2474
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Portland, Oregon 97220
Principal Investigator: Jacob Abraham, MD
Phone: 503-216-7370
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16 West Jones Street
Raleigh, North Carolina 27599
Principal Investigator: Christopher Chien, MD
Phone: 919-962-4896
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Raleigh, NC
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Salt Lake City, Utah 84132
Principal Investigator: Stavros Drakos, MD
Phone: 801-585-2340
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3131 Berger Avenue
San Diego, California 92123
Principal Investigator: Brian Jaske, MD
Phone: 858-244-6886
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Winston-Salem, North Carolina 27610
Principal Investigator: Priyesh Patel, MD
Phone: 919-350-2243
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