PROACTIVE-HF IDE Trial Heart Failure NYHA Class III

該当なし実施中（募集終了） NCT04089059

対象疾患	Heart Failure NYHA Class III
相	該当なし
スポンサー	Endotronix, Inc.
ステータス	実施中（募集終了）
参加者数	738 名
介入（薬剤）	Cordella™ Pulmonary Artery Sensor System
開始日	2020年1月10日
完了日	2028年4月
結果公開日	2025年3月3日

概要

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 Arm	0.2787 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 Arm	0.986 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 Arm	1.000 Proportion of patients without a PSF

BENITIONS で見る ClinicalTrials.gov の原文を見る

同じ疾患の他の治験

Implantation of a Permanent Interatrial Shunt to Reduce Left Atrial Filling Pressures Foll — samir kapadia
Precision Guided Tacrolimus Dosing in Pediatric Heart Transplant — University of Utah
Mechanism and Effects of Manipulating Chloride Homeostasis in Acute Heart Failure — Yale University
Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using th — Boston Children's Hospital
Improving How Older Adults at Risk for Cardiovascular Outcomes Are Selected for Care Coord — Weill Medical College of Cornell University
Crome/Cobalt Respiration Study — Medtronic Cardiac Rhythm and Heart Failure

すべての治験

このページは ClinicalTrials.gov の公開データをまとめたものです。医学的助言ではなく、投資助言でもありません。必ず専門医にご相談ください。

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