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CardiAMP™ Heart Failure Trial

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ClinicalTrials.gov Identifier: NCT02438306
Recruitment Status : Recruiting
First Posted : May 8, 2015
Last Update Posted : October 24, 2018
Sponsor:
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


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

  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

  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

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



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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
Criteria

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%.

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 ClinicalTrials.gov identifier (NCT number): NCT02438306


Contacts
Contact: Eric Duckers, MD, PhD 650-226-0120 info@biocardia.com

Locations
United States, Arizona
Mayo Clinic Recruiting
Phoenix, Arizona, United States, 85054
Contact: Sarah Kirkland       Kirkland.Sarah@mayo.edu   
United States, California
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Tracey Early, BS       Tracey.Early@cshs.org   
Stanford Medical Center, Stanford Health Care Recruiting
Palo Alto, California, United States, 94305
Contact: Fouzia Khan, BS       fouziak@stanford.edu   
United States, Colorado
University of Colorado, Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Alisha Shudy       Alisha.Shudy@ucdenver.edu   
United States, District of Columbia
MedStar Health Research Institute Recruiting
Washington, District of Columbia, United States, 20010
Contact: Shreejana Pokharel, MPH       Shreejana.Pokharel@medstar.net   
United States, Florida
Morton Plant Mease Health Care Recruiting
Clearwater, Florida, United States, 33756
Contact: Delia Johnson, RN       Delia.Johnson@baycare.org   
University of Florida - College of Medicine/ div of Cardiovascular Medicine Recruiting
Gainesville, Florida, United States, 32606
Contact: Sarah J Long, RN    352-265-0111    Sarah.Long@medicine.ufl.edu   
United States, Iowa
Iowa Heart Recruiting
Des Moines, Iowa, United States, 50266
Contact: Megan Murphy, RN       MMurphy@iowaheart.com   
United States, Maryland
John Hopkins University School of Medicine - Dept of Cardiology Recruiting
Baltimore, Maryland, United States, 21287
Contact: Audrey Dudek, RN       adudek1@jhmi.edu   
Suburban Hospital Recruiting
Bethesda, Maryland, United States, 20814
Contact: Mandy Murphy, RN       Mmurph70@jhmi.edu   
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Margaret Fox, RN       MFOX@hfhs.org   
Michigan Heart - St.Joseph Mercy Health System (Trinity Health) Recruiting
Ypsilanti, Michigan, United States, 48197
Contact: Nora Marchelletta, RN       nmarchelletta@MichiganHeart.com   
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Coley Landvik, RN       clandvik@umn.edu   
United States, New Jersey
Atlantic Health System Recruiting
Morristown, New Jersey, United States, 07960
Contact: Cathy VanZile, RN       Catherine.VanZile@atlantichealth.org   
United States, Oklahoma
Oklahoma Heart Recruiting
Tulsa, Oklahoma, United States, 74104
Contact: Jolene Durham, RN, MSN       S.Durham@hillcrest.com   
United States, Virginia
Virginia Commonwealth University (VCU) Medical Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Melissa Sears, RN       melissa.sears@vcuhealth.org   
United States, Washington
Swedish Health Services Recruiting
Seattle, Washington, United States
Contact: Charlene Boisjolie, MA, RN       Charlene.Boisjolie@swedish.org   
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       cav@medicine.wisc.edu   
Sponsors and Collaborators
BioCardia, Inc.
Investigators
Principal Investigator: Carl Pepine, MD University of Florida
Principal Investigator: Amish Raval, MD University of Wisconsin, Madison

Additional Information:
Responsible Party: BioCardia, Inc.
ClinicalTrials.gov Identifier: NCT02438306     History of Changes
Other Study ID Numbers: BC-14-001
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases