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

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.

Study Overview

• Status: Withdrawn
• Conditions: Cardiac Event; Cardiac Disease; STEMI; Heart Attack; Cardiac Infarct; NSTEMI
• Intervention / Treatment: Device: ZOLL Arrhythmia Management System

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 Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Post-MI patients with an EF >35% undergoing cardiac rehabilitation

Description

Inclusion Criteria

1. Both male and female subjects who are between 21 - 75 years of age, inclusively
2. Subjects who are consented and enrolled into the study prior to discharge from the qualifying acute myocardial infarction
3. Subjects with a consistent EF >35% post the qualifying acute myocardial infarction

Exclusion Criteria

1. Subjects with an implantable cardiac device such as left ventricular assistive device, pacemaker, an implanted cardioverter defibrillator (ICD), a cardiac resynchronization therapy device, subcutaneous ICDs, pressure monitors, and loop monitors.
2. Subjects with wearable cardioverter defibrillator, Holter monitors, wearable event recorders, and other mobile cardiac telemetry devices at the same time.
3. Subjects with a skin condition preventing them from wearing the AMS device.
4. Subjects who are non-ambulatory for any reason.
5. Subjects who are self-reporting to be pregnant.
6. Subjects with comorbidities that would preclude adherence to a cardiac rehabilitation program - at the discretion of the physician.
7. Subjects participating or planning to participate in another interventional study during the protocol-defined study period

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Active Treatment; 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	Device: ZOLL Arrhythmia Management System; AMS records rhythm, heart rate, subject-reported symptoms, and multiple parameters that include respiration rate, activity, and body posture (biometric data); Other Names: AMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac rehabilitation program referrals and completions (in-clinic or home-based)	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	30-60 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zoll Medical Corporation

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2023
• Primary Completion (Estimated): July 1, 2023
• Study Completion (Estimated): October 1, 2023

Study Registration Dates

• First Submitted: January 23, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Estimated): July 24, 2023

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: STEMI; myocardial infarction; NSTEMI; heart attack
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Vascular Diseases; Infarction; Myocardial Infarction; Heart Diseases; Cardiovascular Diseases
• Other Study ID Numbers: 90D0257

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No