BENITIONSClinical Trial Intelligence

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
分期不适用
申办方Endotronix, Inc.
状态进行中(已停止招募)
受试者人数738 人
干预(药物)Cordella™ Pulmonary Artery Sensor System
开始日期2020年1月10日
完成日期2028年4月
结果公布日2025年3月3日

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
Former Control Arm0.2787 Events Per Patient Per 6 Months
p-value<0.0001

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
Former Control Arm0.986 Proportion of patients without a DSRC

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
Former Control Arm1.000 Proportion of patients without a PSF

在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文

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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。