跳至主要内容
临床试验/NCT05957172
NCT05957172撤回不适用

Mobile Advanced Multi-Parameter Reporting in Patients Wearing a Novel Device: Utilization During Cardiac Rehabilitation

Zoll Medical Corporation0 个研究点开始时间: 2023年1月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Cardiac rehabilitation program referrals and completions (in-clinic or home-based)

研究概览

简要总结

Advanced remote multi-parameter reporting during cardiac rehabilitation (MAPS-III). The primary purpose of this observational study is to collect baseline information of cardiac rehabilitation usage in the US for post-myocardial infarction (MI) patients with EF > 35% while wearing the ZOLL AMS device for 30 to 60 days. Secondary data on biometrics, arrhythmias, symptoms, and healthcare utilization will provide additional background information on this population during the early post-MI cardiac rehabilitation period.

详细描述

To collect baseline data on cardiac rehabilitation usage (referrals and completion) in recent post-MI patients with EF > 35%.To collect data on AMS-derived biometric data (e.g. HR, activity) and arrhythmias, and subject-reported symptoms, beta blocker/ivabradine usage (dose/changes) and cardiovascular events. The participating centers will enroll consenting subjects in a sequential manner to avoid preferential selection of patients to participate in the study. Subjects will be consented by the center study staff, and if eligible will wear the FDA-cleared AMS device for 30-60 days. Subject demographic information and clinical history will be obtained at the time of enrollment. During the study period, the prescribing physician-investigator will be blinded to AMS data. Final subject follow-up will be at 3 months. A sample size of 150 subjects is estimated in order to have 100 subjects with at least 30 days of AMS use for analysis.

研究设计

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

入排标准

年龄范围
21 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Cardiac rehabilitation program referrals and completions (in-clinic or home-based)

时间窗: 30-60 days

Measure the completion rate of patients undergoing cardiac rehabilitation programs i.e. the number of cardiac rehabilitation program referrals vs. number of cardiac rehabilitation program completions

次要结局

  • AMS-derived data - Activity(30-60 days)
  • AMS-derived data - Arrhythmias(30-60 days)
  • AMS-derived data - Heart Rate(30-60 days)
  • Subject reported outcomes - Symptoms(30-60 days)
  • Subject reported outcomes - Beta blocker/ivabradine usage/changes(30-60 days)
  • Subject reported outcomes - Cardiovascular events(30-60 days)

研究者

申办方类型
Industry
责任方
Sponsor

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