临床试验/NCT03723265

NCT03723265已完成不适用

Personalized CRT - Product Surveillance Registry (PSR)

Medtronic0 个研究点目标入组 1,517 人开始时间: 2012年1月最近更新: 2022年5月20日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Medtronic
入组人数: 1,517
主要终点: CRT Response

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the cardiac resynchronization therapy (CRT) response in a real-world patient population and evaluate options to address non-response and patient management.

详细描述

The Personalized CRT study is a multi-center, single arm, prospective observational study. The purpose of the study is to better understand and characterize heart failure (HF) patient management by characterizing the use and clinical benefit of Medtronic market-released features/tools within the HF Patient Management portfolio.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
•Patient has or is intended to receive or be treated with an eligible CRT device
•Patient within 30 days of therapy received at the time of their initial PSR platform enrollment

排除标准

•Patient who is, or is expected to be inaccessible for follow-up
•Patient with exclusion criteria required by local law
•Patient is currently enrolled in or plans to enroll in any concurrent drug and/ or device study that may confound results

结局指标

主要结局

CRT Response

时间窗: Every 3-9 months

A Clinical Composite Score (CCS) endpoint will be used to assess a change in CRT response for all patients from baseline to follow-up visits.

次要结局

Treatment effects for different CRT features in the CRT non-responder population(Every 3-9 months)
Patient outcome post initial CRT implant(Every 3-9 months)
Treatments for CRT non-response(Every 3-9 months)

研究者

发起方

Medtronic

申办方类型

Industry

责任方

Sponsor

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