A Registry to Assess the Ongoing Safety for Subjects That Have Been Randomized and Completed a Juventas Sponsored Heart Failure Protocol Under IND # 14203
试验速览
- 阶段
- 不适用
- 入组人数
- 165
- 试验地点
- 14
- 主要终点
- Morbidity/Mortality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participated in and completed a Juventas sponsored heart failure study under IND 14203
排除标准
- •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
结局指标
主要结局
Morbidity/Mortality
时间窗: 3 years
A questionnaire will be used to assess the ongoing safety of subjects including morbidity/mortality parameters as they relate to heart failure.
次要结局
- Newly diagnosed malignancies(3 years)