PROACTIVE-HF IDE Trial Heart Failure NYHA Class III

단계 해당 없음 진행 중(모집 완료) NCT04089059

요약

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

Safety: Freedom From Device/System Related Complication

6 months · Proportion of patients without a DSRC

Safety: Freedom From Pressure Sensor Failure

6 months · Proportion of patients without a PSF

BENITIONS에서 보기 ClinicalTrials.gov 원문 보기

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