Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT02438306
Recruitment Status : Recruiting
First Posted : May 8, 2015
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
BioCardia, Inc.

Tracking Information
First Submitted Date  ICMJE May 5, 2015
First Posted Date  ICMJE May 8, 2015
Last Update Posted Date August 16, 2019
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
Six (6) Minute Walk Distance [ Time Frame: 12 Months ]
Mean change in Six (6) Minute Walk Distance at 12 months compared to baseline
Original Primary Outcome Measures  ICMJE
 (submitted: May 7, 2015)
Change in Six (6) Minute Walk Distance at 12 months from baseline [ Time Frame: 12 Months ]
Change History Complete list of historical versions of study NCT02438306 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2019)
  • Survival Rate [ Time Frame: 12 Months ]
    Survival rate compared between both study arms (non-inferiority, treatment vs sham)
  • 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)
  • 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)
  • 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)
  • Survival rate [ Time Frame: 12 months ]
    Survival rate compared between both study arms (superiority, treatment vs sham)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2015)
  • Overall survival as a non-inferiority outcome [ Time Frame: 12 Months ]
  • Freedom from Major Adverse Cardiac Events (composite of all-cause death,hospitalization for worsening heart failure, nonfatal MI, [LVAD], or heart transplantation) as a non-inferiority outcome [ Time Frame: 12 months ]
  • Change in quality of life as measured by Minnesota Living with Heart Failure questionnaire as a superiority outcome [ Time Frame: 12 months ]
  • Overall survival as a superiority outcome [ Time Frame: 12 months ]
  • Survival at 2 years [ Time Frame: 24 months ]
  • Heart Failure Death [ Time Frame: 12 months ]
  • Treatment-emergent Serious Adverse Event at 30-days [ Time Frame: 1 month ]
  • Heart Failure Hospitalization [ Time Frame: 12 months ]
  • All-cause Hospitalization [ Time Frame: 12 months ]
  • Days alive out of hospital [ Time Frame: 12 months ]
  • Freedom from Serious Adverse Events [ Time Frame: 12 months ]
  • NYHA Functional Class [ Time Frame: 12 months ]
  • Time to first MACE [ Time Frame: 12 months ]
  • 6 MWD repeated measure analysis [ Time Frame: 12 months ]
  • Echocardiographic measures of change in ejection fraction, left ventricular end systolic and end diastolic volumes, left ventricular end systolic and end diastolic dimensions, mitral regurgitation (composite) [ Time Frame: 12 months ]
  • Technical Success defined as 10 successful injections of ABM MNC to the target locations. [ Time Frame: Baseline ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CardiAMP™ Heart Failure Trial
Official Title  ICMJE 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)
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: CardiAMP cell therapy
    Placement of an introducer guidewire, performance of a left ventriculogram, and treatment with autologous cell therapy.
    Intervention: Biological: Autologous cell therapy
  • Sham Comparator: Sham Comparator
    Placement of an introducer guidewire and performance of a left ventriculogram with no autologous cell therapy treatment.
    Intervention: Other: Sham
Publications * Raval AN, Cook TD, Duckers HJ, Johnston PV, Traverse JH, Abraham WT, Altman PA, Pepine CJ. The CardiAMP Heart Failure trial: A randomized controlled pivotal trial of high-dose autologous bone marrow mononuclear cells using the CardiAMP cell therapy system in patients with post-myocardial infarction heart failure: Trial rationale and study design. Am Heart J. 2018 Jul;201:141-148. doi: 10.1016/j.ahj.2018.03.016. Epub 2018 Apr 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 7, 2015)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Eric Duckers, MD, PhD 650-226-0120 info@biocardia.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02438306
Other Study ID Numbers  ICMJE BC-14-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party BioCardia, Inc.
Study Sponsor  ICMJE BioCardia, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carl Pepine, MD University of Florida
Principal Investigator: Amish Raval, MD University of Wisconsin, Madison
PRS Account BioCardia, Inc.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP