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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long-term safety follow-up | To be eligible, subjects must have actively participated in a Juventas (JVS-100) sponsored trial under IND 14203. |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Newly diagnosed malignancies | A questionnaire will be used to track any newly diagnosed malignancies. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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The patient population eligible for the proposed Registry will be subjects who have completed a Juventas sponsored heart failure study under IND 14203. The patient population will primarily be comprised of symptomatic systolic heart failure patients due to ischemic etiology.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology, P.C. | Birmingham | Alabama | 35211 | United States | ||
| University of Florida |
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| Gainsville |
| Florida |
| 32610-0277 |
| United States |
| Pepin Heart Institute | Tampa | Florida | 33613 | United States |
| Iowa Heart Center | Des Moines | Iowa | 50026 | United States |
| University of Kentucky Gill Heart Institute | Lexington | Kentucky | 40536 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Michigan Cardiovascular Institute | Saginaw | Michigan | 48601 | United States |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Summa Health System | Akron | Ohio | 44309 | United States |
| The Carl and Edyth Lindner Center for Research & Education at The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |