MOMENTUM 3 IDE Clinical Study Protocol



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 100
Updated:2/1/2019
Start Date:September 2, 2014
End Date:April 2019

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Thoratec Corporation MOMENTUM 3, Multi-center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ IDE Clinical Study Protocol

The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by
demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of
advanced, refractory, left ventricular heart failure.

The HM3 LVAS is intended to provide hemodynamic support in patients with advanced, refractory
left ventricular heart failure; either for short term support, such as a bridge to cardiac
transplantation (BTT) or myocardial recovery, or as long term support, such as destination
therapy (DT). The HM3 is intended for use inside or outside the hospital.

Inclusion Criteria:

1. Subject or legal representative has signed Informed Consent Form (ICF)

2. Age ≥ 18 years

3. BSA ≥ 1.2 m2

4. NYHA Class III with dyspnea upon mild physical activity, or NYHA Class IV

5. LVEF ≤ 25%

6. a) Inotrope dependent OR b) CI < 2.2 L/min/m2, while not on inotropes and subjects
must also meet one of the following:

- On Optimal Medical Management (OMM), based on current heart failure practice
guidelines for at least 45 out of the last 60 days and are failing to respond

- Advanced Heart Failure for at least 14 days AND dependent on intra-aortic balloon
pump (IABP) for at least 7 days

7. Females of child bearing age must agree to use adequate contraception

Exclusion Criteria:

1. Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease,
obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive
cardiomyopathy

2. Technical obstacles which pose an inordinately high surgical risk, in the judgment of
the investigator

3. Existence of ongoing mechanical circulatory support (MCS) other than IABP

4. Positive pregnancy test if of childbearing potential

5. Presence of mechanical aortic valve that will not be either converted to a
bioprosthesis or oversewn at the time of LVAD implant

6. History of any organ transplant

7. Platelet count < 100,000 x 103/L (< 100,000/ml)

8. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial
issues that are likely to impair compliance with the study protocol and LVAS
management

9. History of confirmed, untreated AAA > 5 cm in diameter within 6 months of enrollment

10. Presence of an active, uncontrolled infection

11. Intolerance to anticoagulant or antiplatelet therapies or any other
peri/post-operative therapy the investigator will require based upon the patients'
health status

12. Presence of any one of the following risk factors for indications of severe end organ
dysfunction or failure:

1. An INR ≥ 2.0 not due to anticoagulation therapy

2. Total bilirubin > 43 umol/L (2.5 mg/dl), shock liver, or biopsy proven liver
cirrhosis

3. History of severe chronic obstructive pulmonary disease (COPD) defined by
FEV1/FVC < 0.7, and FEV1 <50% predicted

4. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is
unresponsive to pharmacologic intervention

5. History of stroke within 90 days prior to enrollment, or a history of
cerebrovascular disease with significant (> 80%) uncorrected carotid stenosis

6. Serum creatinine ≥ 221 umol/L (2.5 mg/dl) or the need for chronic renal
replacement therapy

7. Significant peripheral vascular disease (PVD) accompanied by rest pain or
extremity ulceration

13. Patient has moderate to severe aortic insufficiency without plans for correction
during pump implant

14. Pre albumin < 150 mg/L (15mg/dL) or Albumin < 30g/L (3 g/dL) (if only one available) ;
pre albumin < 150 mg/L (15mg/dL) and Albumin < 30g/L (3 g/dL) (if both available)

15. Planned Bi-VAD support prior to enrollment

16. Patient has known hypo or hyper coagulable states such as disseminated intravascular
coagulation and heparin induced thrombocytopenia

17. Participation in any other clinical investigation that is likely to confound study
results or affect the study

18. Any condition other than HF that could limit survival to less than 24 months
We found this trial at
69
sites
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Mary Keebler, MD
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Michael Givertz, MD
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Jason Katz, MD
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
Principal Investigator: Eric Skipper, MD
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Carmelo Milano, MD
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Principal Investigator: Shashank Desai, MD
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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Gainesville, Florida 32610
Principal Investigator: Charles Klodell, MD
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Pavan Atluri, MD
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Frederick Tibayan, MD
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Principal Investigator: Leway Chen, MD
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Principal Investigator: Christiano Caldeira, MD
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Francis Pagani, MD
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Atlanta, Georgia 30309
Principal Investigator: David Dean, MD
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
Principal Investigator: Andreas Brieke, MD
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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1800 Orleans Street
Baltimore, Maryland 21287
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Beverly Hills, California 90211
Principal Investigator: Francisco Arabia, MD
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Adrian Van Bakel, MD
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlottesville, Virginia 22908
Principal Investigator: John Kern, MD
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Principal Investigator: Allen Anderson, MD
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
Principal Investigator: Sirtaz Adatya, MD
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Nader Moazami, MD
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Columbus, Ohio 43210
Principal Investigator: Ahmet Kilic, MD
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3310 Live Oak St
Dallas, Texas 75204
(214) 820-2687
Principal Investigator: Brian Lima, MD
Baylor Research Institute Baylor Research Institute (BRI) is a dedicated research center for finding prevention...
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: Hassan Nemeh, MD
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Grand Rapids, Michigan 44506
Principal Investigator: Martin Streuber, MD
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Hershey, Pennsylvania 17033
Principal Investigator: Walter Pae, MD
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Houston, Texas 77030
Principal Investigator: Igor Gregoric, MD
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Houston, Texas 77030
Principal Investigator: Brian Bruckner, MD
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Houston, Texas 77225
Principal Investigator: Steve Singh, MD
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Indianapolis, Indiana 46202
Principal Investigator: I-Wen Wang, MD
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Indianapolis, Indiana
Principal Investigator: Mary Walsh, MD
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Principal Investigator: Jay Bhama, MD
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
Principal Investigator: Eric Adler, MD
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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800 Rose Street
Lexington, Kentucky 40536
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Little Rock, Arkansas 72205
Principal Investigator: John Ransom, MD
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Louisville, Kentucky 40202
Principal Investigator: Mark Slaughter, MD
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Madison, Wisconsin 53792
Principal Investigator: Shahab Akhter, MD
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Milwaukee, Wisconsin 53215
Principal Investigator: Francis Downey, MD
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2450 Riverside Ave
Minneapolis, Minnesota 55454
(612) 273-3000
Principal Investigator: Ranjit John, MD
University of Minnesota Medical Center, Fairview Improving patients' lives drives the innovation that makes University...
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800 E 28th St
Minneapolis, Minnesota 55407
(612) 863-4000
Abbott Northwestern Hospital Our hospital has a long and proud history as a health care...
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Nashville, Tennessee 37205
Principal Investigator: Don Chomsky, MD
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Principal Investigator: Abeel Mangi, MD
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
Principal Investigator: Aditya Bansai, MD
Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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New York, New York 10029
Principal Investigator: Anelechi Anyanwu, MD
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Yoshifumi Naka, MD
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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201 Lyons Ave
Newark, New Jersey 07112
(973) 926-7000
Principal Investigator: Margarita Camacho, MD
Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
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600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
Principal Investigator: Michael McGrath, MD
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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4440 West 95th Street
Oak Lawn, Illinois 60453
708.684.8000
Principal Investigator: Antone Tatooles, MD
Advocate Christ Medical Center Advocate Health Care, named among the nation
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Oklahoma City, Oklahoma
Principal Investigator: James Long, MD
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: John Um, MD
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Principal Investigator: Scott Silvestry, MD
Florida Hospital Florida Hospital is one of the country
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: John Entwistle III, MD
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Principal Investigator: Stephen Bailey, MD
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Richmond, Virginia 23226
Principal Investigator: Marc Katz, MD
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Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: Vigneshwar Kasirajan, MD
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Principal Investigator: John Stulak, MD
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Sacramento, California 95815
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Saint Louis, Missouri 63110
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Salt Lake City, Utah 84132
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7901 Frost Street
San Diego, California 92123
858-939-3400
Principal Investigator: Robert Adamson, MD
Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
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45 Castro Street
San Francisco, California 94114
(415) 600-6000
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
Principal Investigator: Nahush Mokadam, MD
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: Richard Ha, MD
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Washington, District of Columbia
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