This is a randomized, double-blind, placebo controlled Phase II study is designed to assess the safety and efficacy of using JVS-100 to treat heart failure.
90 subjects with ischemic cardiomyopathy will be randomized to receive a single dose of 15 or 30 mg of JVS-100 or matching placebo. Subjects will be randomized 1:1:1 to receive either placebo, 15 mg or 30 mg of JVS-100. Subjects will be monitored overnight for 18-24 hours post dose and have scheduled visits at 3 days post-injection for safety evaluations. All subjects will be scheduled for follow-up visits at approximately 30 days (1 month), 120 days (4 months), and 360 days (12 months) to assess safety and cardiac function.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Intramyocardial Injection
Intramyocardial Injection
Intramyocardial Injection
Cardiology PC
Birmingham, Alabama, United States
University of Florida
Gainesville, Florida, United States
Impact of JVS-100 injection on Six Minute Walk Distance (6MWD) at 4 month follow-up
To investigate the impact of single doses of JVS-100 (either 15 or 30 mg) delivered via endomyocardial injection through the BioCardia Helical Infusion catheter on 6 minute walk distance compared to placebo at 4 months post-dosing
Time frame: 4 Months
Impact of JVS-100 injection on Quality of Life at 4 month follow-up
To investigate the impact of single doses of JVS-100 (either 15 or 30 mg) delivered via endomyocardial injection through the BioCardia Helical Infusion catheter on quality of life measured by the Minnesota Living with Heart Failure Questionnaire compared to placebo at 4 months post-dosing
Time frame: 4 months
Impact of JVS-100 Injection on Quality of Life
To investigate the impact of single doses of JVS-100 (either 15 or 30 mg) delivered via endomyocardial injection through the BioCardia Helical Infusion catheter on quality of life measured by the Minnesota Living with Heart Failure Questionnaire compared to placebo at 12 months post-dosing
Time frame: 12 Months
Impact of JVS-100 Injection on NYHA class
To investigate the impact of single doses of JVS-100 (either 15 or 30 mg) delivered via endomyocardial injection through the BioCardia Helical Infusion catheter on NYHA class compared to placebo at 4 months post-dosing
Time frame: 4 months
Impact of JVS-100 Injection on LVEF
To investigate the impact of single doses of JVS-100 (either 15 or 30 mg) delivered via endomyocardial injection through the BioCardia Helical Infusion catheter on Left Ventricular Ejection Fraction as measured by echocardiography compared to placebo at 4 months post-dosing
Time frame: 4 months
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Pepin Heart Institute
Tampa, Florida, United States
Iowa Heart Center
Des Moines, Iowa, United States
Johns Hopkins University
Baltimore, Maryland, United States
Spectrum Health
Grand Rapids, Michigan, United States
Michigan Cardiovascular Institute
Saginaw, Michigan, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
Washington University in St. Louis
St Louis, Missouri, United States
Columbia University Medical Center
New York, New York, United States
...and 6 more locations
Impact of JVS-100 Injection on Time to First Heart Failure Decompensation
To investigate the impact of single doses of JVS-100 (either 15 or 30 mg) delivered via endomyocardial injection through the BioCardia Helical Infusion catheter on the time to first heart failure decompensation compared to placebo
Time frame: Up to 12 months
Impact of JVS-100 Injection on Major Adverse Cardiac Events
To investigate the impact of single doses of JVS-100 (either 15 or 30 mg) delivered via endomyocardial injection through the BioCardia Helical Infusion catheter on the number of major adverse cardiac events (MACE) compared to placebo
Time frame: Up to 12 months
Impact of JVS-100 Injection on number of adverse events
To investigate the impact of single doses of JVS-100 (either 15 or 30 mg) delivered via endomyocardial injection through the BioCardia Helical Infusion catheter on the number of adverse events compared to placebo
Time frame: Up to 12 months
Impact of JVS-100 Injection on number of serious adverse events
To investigate the impact of single doses of JVS-100 (either 15 or 30 mg) delivered via endomyocardial injection through the BioCardia Helical Infusion catheter on the number of serious adverse events compared to placebo
Time frame: Up to 12 months