PROACTIVE-HF IDE Trial Heart Failure NYHA Class III
不适用
进行中(已停止招募)
NCT04089059
| 适应症 | Heart Failure NYHA Class III |
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| 分期 | 不适用 |
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| 申办方 | Endotronix, Inc. |
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| 状态 | 进行中(已停止招募) |
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| 受试者人数 | 738 人 |
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| 干预(药物) | Cordella™ Pulmonary Artery Sensor System |
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| 开始日期 | 2020年1月10日 |
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| 完成日期 | 2028年4月 |
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| 结果公布日 | 2025年3月3日 |
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摘要
This is a prospective, open- label, single arm, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System in NYHA Class III Heart Failure Patients compared to a Performance Goal (PG).
Efficacy 6 Month Incidence of HF Related Hospitalizations (HFH) or All-cause Mortality
6 months · Events Per Patient Per 6 Months
| Modified Intent-to-Treat (mITT) | 0.1549 Events Per Patient Per 6 Months |
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| Former Control Arm | 0.2787 Events Per Patient Per 6 Months |
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Safety: Freedom From Device/System Related Complication
6 months · Proportion of patients without a DSRC
| Intent-to-Treat (ITT) | 0.992 Proportion of patients without a DSRC |
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| Former Control Arm | 0.986 Proportion of patients without a DSRC |
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Safety: Freedom From Pressure Sensor Failure
6 months · Proportion of patients without a PSF
| Intent-to-Treat (ITT) | 0.998 Proportion of patients without a PSF |
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| Former Control Arm | 1.000 Proportion of patients without a PSF |
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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。