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

Withdrawn

• Conditions: NSTEMI; Cardiac Infarct; STEMI; Cardiac Event; Heart Attack; Cardiac Disease
• Interventions: Device: ZOLL Arrhythmia Management System

• Registration Number: NCT05957172
• Lead Sponsor: Zoll Medical Corporation

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2023-01
• Study First Submitted: 2023-01-23
• Status Verified: 2023-07
• Primary Completion: 2023-07
• Study First Submitted QC: 2023-07-13
• Last Update Submitted: 2023-07-13
• Study First Posted: 2023-07-24
• Last Update Posted: 2023-07-24
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Active Treatment	ZOLL Arrhythmia Management System	Subjects assigned to wear the FDA-cleared AMS device for 30-60 days Sequential enrollment to avoid preferential selection Investigator blinded to the AMS data

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
AMS-derived data - Activity	30-60 days	Changes in total daily activity as detected by the AMS accelerometers
AMS-derived data - Arrhythmias	30-60 days	Occurrence of Arrhythmias as detected by the AMS
AMS-derived data - Heart Rate	30-60 days	Improvement in nighttime resting heart rate
Subject reported outcomes - Symptoms	30-60 days	Occurrence and changes in symptoms recorded via weekly diary
Subject reported outcomes - Beta blocker/ivabradine usage/changes	30-60 days	Initiation/Termination/Changes in beta blocker/ivabradine usage recorded via weekly diary
Subject reported outcomes - Cardiovascular events	30-60 days	Cardiovascular events as measured by health care use i.e. unplanned health care provider visits due to cardiovascular event, recorded via weekly diary