Registry to Assess Safety for Subjects That Have Completed a Juventas Sponsored HF Protocol Under IND # 14203

Study Overview
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Brief Summary
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This is an exploratory registry that will include subjects who have been randomized to receive JVS-100 treatment (at one of multiple doses) or placebo by one of a number of delivery systems (e.g. endomyocardial injection, retrograde infusion) in a previous Juventas clinical trial.

Detailed Description
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This Registry will assess the ongoing safety of subjects including morbidity/mortality parameters as they relate to heart failure and track any newly diagnosed malignancies. The logistics of the study are as follows: to be eligible, subjects must have actively participated in a Juventas sponsored trial under IND 14203. After consent, subjects will be followed for up to three years post receipt of investigational product during which time they will receive phone calls (every 3 months) from the study site asking about their health. Questions will be aimed at cardiovascular related events including: Hospitalizations ER Visits Unscheduled visits with Cardiologist Newly diagnosed malignancies Serious Adverse Events (SAEs) will not be reported in this study; however, data pertaining to such events will be captured (i.e. date of admission and diagnosis.). Data will be captured on paper CRFs, collected by Juventas (or their designee) and will be entered into a clinical database for analysis.

Official Title
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A Registry to Assess the Ongoing Safety for Subjects That Have Been Randomized and Completed a Juventas Sponsored Heart Failure Protocol Under IND # 14203

Conditions
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Ischemic Heart Failure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participated in and completed a Juventas sponsored heart failure study under IND 14203 Exclusion Criteria: Unwillingness to sign informed consent form Unwillingness or inability to receive phone calls for required follow up assessments Subjects actively participating in another regenerative medicine trial should be discussed with sponsor prior to enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Long-term safety follow-up<br>To be eligible, subjects must have actively participated in a Juventas (JVS-100) sponsored trial under IND 14203. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity/Mortality | A questionnaire will be used to assess the ongoing safety of subjects including morbidity/mortality parameters as they relate to heart failure. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Newly diagnosed malignancies | A questionnaire will be used to track any newly diagnosed malignancies. | 3 years |