Heart Failure Clinical Trial

CardiAMP™ Cell Therapy Heart Failure Trial

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.

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Full 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

View Eligibility Criteria

Eligibility 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%.
Qualification of a pre-procedure screening of bone-marrow aspiration

Exclusion Criteria:

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

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

250

Study ID:

NCT02438306

Recruitment Status:

Recruiting

Sponsor:

BioCardia, Inc.

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There are 30 Locations for this study

See Locations Near You

Cardiology PC
Birmingham Alabama, 35211, United States More Info
Susan DeRamus
Contact
[email protected]
Mayo Clinic
Phoenix Arizona, 85054, United States
USC
Los Angeles California, 90033, United States
Cedars Sinai Medical Center
Los Angeles California, 90048, United States More Info
Klevin Reyes
Contact
[email protected]
Stanford Medical Center, Stanford Health Care
Palo Alto California, 94305, United States More Info
Fouzia Khan, BS
Contact
[email protected]
California Pacific Medical Center
San Francisco California, 94115, United States More Info
Milena Ferreira
Contact
[email protected]
University of Colorado, Denver
Aurora Colorado, 80045, United States More Info
Jackson Hayes, BS
Contact
[email protected]
MedStar Health Research Institute
Washington District of Columbia, 20010, United States More Info
Shreejana Pokharel, MPH
Contact
[email protected]
Morton Plant Mease Health Care
Clearwater Florida, 33756, United States More Info
Delia Johnson, RN
Contact
[email protected]
University of Florida - College of Medicine/ div of Cardiovascular Medicine
Gainesville Florida, 32606, United States More Info
Sarah J Long, RN
Contact
[email protected]
Northwestern University
Chicago Illinois, 60611, United States
Iowa Heart
Des Moines Iowa, 50266, United States More Info
Colleena Schaefer, RN
Contact
515-235-5114
[email protected]
John Hopkins University School of Medicine - Dept of Cardiology
Baltimore Maryland, 21287, United States More Info
Michele Fisher, RN
Contact
[email protected]
Suburban Hospital
Bethesda Maryland, 20814, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States More Info
Margaret Fox, RN
Contact
[email protected]
Melanee Schimmel, RN
Contact
[email protected]
Michigan Cardiovascular Institute
Saginaw Michigan, 48601, United States More Info
Brandon Gagnon, RN
Contact
989-907-8031
[email protected]
Michigan Heart - St.Joseph Mercy Health System (Trinity Health)
Ypsilanti Michigan, 48197, United States More Info
Nora Marchelletta, RN
Contact
[email protected]
University of Minnesota
Minneapolis Minnesota, 55455, United States
Saint Luke's Hospital
Kansas City Missouri, 64111, United States More Info
Jackie Smith, RN
Contact
816-932-8414
[email protected]
Atlantic Health System
Morristown New Jersey, 07960, United States More Info
Jessica Bukhari, BSN, RN
Contact
973-971-8597
[email protected]
New York University School of Medicine
New York New York, 10010, United States More Info
Sevinj Sasunova
Contact
[email protected]
Cornell University
New York New York, 10065, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States More Info
Danielle Kellner, MSN
Contact
216-445-6321
[email protected]
Oklahoma Heart
Tulsa Oklahoma, 74104, United States More Info
Colene Hollandson, RN, BSN
Contact
918-295-0300
[email protected]
Stern Cardiovascular Foundation
Memphis Tennessee, 38103, United States More Info
Kari Fondren, RN
Contact
901-271-4062
kar[email protected]
Texas Heart Institute
Houston Texas, 77030, United States
Virginia Commonwealth University (VCU) Medical Center
Richmond Virginia, 23298, United States
Swedish Health Services
Seattle Washington, 98122, United States
Division of Cardiovascular Medicine, University of Wisconsin Hospital and Clinics
Madison Wisconsin, 53792, United States More Info
Cassondra Vander Ark, RN MS CCRC
Contact
[email protected]
Ottawa Heart Institute
Ottawa Ontario, KIY 4, Canada More Info
Nancy Page
Contact
613-696-7000
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

250

Study ID:

NCT02438306

Recruitment Status:

Recruiting

Sponsor:


BioCardia, Inc.

How clear is this clinincal trial information?

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