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CardiAMP™ Heart Failure Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02438306
Recruitment Status : Recruiting
First Posted : May 8, 2015
Last Update Posted : August 16, 2019
Information provided by (Responsible Party):
BioCardia, Inc.

Brief Summary:
This is a prospective, multi-center, randomized (3 Treatment : 2 Sham Control), sham-controlled, patient- and evaluator-blinded study comparing treatment with the CardiAMP cell therapy to a sham treatment. A roll-in phase with a maximum of 10 subjects may occur.

Condition or disease Intervention/treatment Phase
Heart Failure Biological: Autologous cell therapy Other: Sham Phase 3

Detailed Description:

Heart failure is a clinical condition in which the output of blood from the heart is insufficient to meet the metabolic demands of the body. In 2015, the American Heart Association, or AHA, report on heart disease statistics estimated that there are 5.7 million Americans over the age of 20 that have heart failure. Heart failure is increasingly prevalent due to the aging population and the increase in major cardiovascular risk factors, including obesity and diabetes.

The AHA also estimates that one in five adults will develop heart failure after the age of 40. During heart failure progression, the heart steadily loses its ability to respond to increased metabolic demand, and mild exercise soon exceeds the heart's ability to maintain adequate output. Towards the end stage of the disease, the heart cannot pump enough blood to meet the body's needs at rest. At this stage, fluids accumulate in the extremities or in the lungs making the patient bedridden and unable to perform the activities of daily living. The long-term prognosis associated with heart failure is approximately 50% mortality at five years following the initial diagnosis.

CardiAMP is a comprehensive therapeutic treatment that comprises (i) a point of care cell processing platform, and (ii) a biotherapeutic delivery system. CardiAMP is the first comprehensive therapeutic treatment utilizing a patient's own cells for the treatment of ischemic systolic heart failure, which is heart failure that develops after a heart attack. In the screening process, the physician extracts a small sample of the patient's bone marrow in an outpatient procedure performed under local anesthesia. The clinic sends the sample to a centralized diagnostic lab, which tests the sample. During the treatment, a clinician harvests and then prepares the patient's own bone marrow mononuclear cells, or autologous cells, using the CardiAMP point of care cell processing platform, which a cardiologist then delivers into the heart using the Helix biotherapeutic delivery system.

BioCardia intends to submit data obtained from this clinical trial in a Pre-Market Approval Application to the United States Food and Drug Administration

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy System in Patients With Post Myocardial Infarction Heart Failure (CardiAMP Heart Failure Trial)
Study Start Date : December 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: CardiAMP cell therapy
Placement of an introducer guidewire, performance of a left ventriculogram, and treatment with autologous cell therapy.
Biological: Autologous cell therapy
Autologous cell therapy delivered into the heart muscle using the CardiAMP Cell Therapy System. The CardiAMP Cell Therapy System consists of the CardiAMP Cell Separator, a cardiac delivery catheter, and flexible tip guide catheter.

Sham Comparator: Sham Comparator
Placement of an introducer guidewire and performance of a left ventriculogram with no autologous cell therapy treatment.
Other: Sham
An introducer guidewire is placed into the heart and left ventriculography is performed just like it is in the Experimental Arm but no autologous cell therapy is delivered.

Primary Outcome Measures :
  1. Six (6) Minute Walk Distance [ Time Frame: 12 Months ]
    Mean change in Six (6) Minute Walk Distance at 12 months compared to baseline

Secondary Outcome Measures :
  1. Survival Rate [ Time Frame: 12 Months ]
    Survival rate compared between both study arms (non-inferiority, treatment vs sham)

  2. Major Adverse Cardiac Events (MACE) [ Time Frame: 12 months ]
    Freedom from MACE, defined as the composite of all-cause death, hospitalization for worsening heart failure, nonfatal recurrent myocardial infarction, placement of a left ventricular assist device (LVAD), or heart transplantation (non-inferiority, treatment vs sham)

  3. Minnesota Living with Heart Failure Questionnaire (MLHFQ) [ Time Frame: 12 months ]
    Mean change in quality of life score as measured by the MLHFQ at 12 months compared to baseline (superiority, treatment vs sham)

  4. Time to first MACE [ Time Frame: 12 months ]
    Time (in days) to first MACE during the 12 months after the baseline measurements (superiority, treatment vs sham)

  5. Survival rate [ Time Frame: 12 months ]
    Survival rate compared between both study arms (superiority, treatment vs sham)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • New York Heart Association (NYHA) Class II or III
  • A diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI).
  • On stable evidence-based medical and device therapy for heart failure or post-infarction left ventricular dysfunction, per the 2013 ACC/AHA Heart Failure guidelines, for at least three (3) months prior to randomization.
  • Left ventricular ejection fraction between 20% and 40%.
  • Cell potency assay score of '3'.

Exclusion Criteria:

• Other cardiac or vascular system or other health-related criteria which may be seen in a patient's history and physical examination.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02438306

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Contact: Eric Duckers, MD, PhD 650-226-0120

  Hide Study Locations
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United States, Arizona
Mayo Clinic Recruiting
Phoenix, Arizona, United States, 85054
Contact: Sarah Kirkland   
United States, California
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Tracey Early, BS   
Stanford Medical Center, Stanford Health Care Recruiting
Palo Alto, California, United States, 94305
Contact: Fouzia Khan, BS   
California Pacific Medical Center Recruiting
San Francisco, California, United States, 94115
Contact: Milena Ferreira   
United States, Colorado
University of Colorado, Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Alisha Shudy   
United States, District of Columbia
MedStar Health Research Institute Recruiting
Washington, District of Columbia, United States, 20010
Contact: Shreejana Pokharel, MPH   
United States, Florida
Morton Plant Mease Health Care Recruiting
Clearwater, Florida, United States, 33756
Contact: Delia Johnson, RN   
University of Florida - College of Medicine/ div of Cardiovascular Medicine Recruiting
Gainesville, Florida, United States, 32606
Contact: Sarah J Long, RN   
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Daniel Roshevsky   
United States, Iowa
Iowa Heart Recruiting
Des Moines, Iowa, United States, 50266
Contact: Megan Murphy, RN   
United States, Maryland
John Hopkins University School of Medicine - Dept of Cardiology Recruiting
Baltimore, Maryland, United States, 21287
Contact: Audrey Dudek, RN   
Suburban Hospital Recruiting
Bethesda, Maryland, United States, 20814
Contact: Sarah Lowe   
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Margaret Fox, RN   
Contact: Melanee Schimmel, RN   
Michigan Cardiovascular Institute Recruiting
Saginaw, Michigan, United States, 48601
Contact: Amanda Reif   
Michigan Heart - St.Joseph Mercy Health System (Trinity Health) Recruiting
Ypsilanti, Michigan, United States, 48197
Contact: Nora Marchelletta, RN   
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Coley Landvik, RN   
United States, New Jersey
Atlantic Health System Recruiting
Morristown, New Jersey, United States, 07960
Contact: Cathy VanZile, RN   
Contact: Jenelle Purpura, RN   
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10010
Contact: Raven Dwyer   
Cornell University Not yet recruiting
New York, New York, United States, 10065
Contact: Heather Glum   
United States, Oklahoma
Oklahoma Heart Recruiting
Tulsa, Oklahoma, United States, 74104
Contact: Jolene Durham, RN, MSN   
United States, Texas
Texas Heart Institute Recruiting
Houston, Texas, United States, 77030
Contact: Sara Sampaio   
United States, Virginia
Virginia Commonwealth University (VCU) Medical Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Laura Cei   
United States, Washington
Swedish Health Services Recruiting
Seattle, Washington, United States, 98122
Contact: Charlene Boisjolie, MA, RN   
United States, Wisconsin
Division of Cardiovascular Medicine, University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792-0001
Contact: Cassondra Vander Ark, RN MS CCRC   
Sponsors and Collaborators
BioCardia, Inc.
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Principal Investigator: Carl Pepine, MD University of Florida
Principal Investigator: Amish Raval, MD University of Wisconsin, Madison

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: BioCardia, Inc. Identifier: NCT02438306     History of Changes
Other Study ID Numbers: BC-14-001
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases