Ignite Creation Date:
2024-05-06 @ 7:17 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05957172
Status:
WITHDRAWN
Last Update Posted:
2023-07-24
First Post:
2023-01-23
Brief Title:
Mobile Advanced Multi-Parameter Reporting in Patients Wearing a Novel Device Utilization During Cardiac Rehabilitation
Sponsor:
Zoll Medical Corporation
Organization:
Zoll Medical Corporation
Study Overview
Official Title:
Mobile Advanced Multi-Parameter Reporting in Patients Wearing a Novel Device Utilization During Cardiac Rehabilitation
Status:
WITHDRAWN
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Futility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAPS-III
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 35To collect data on AMS-derived biometric data eg HR activity and arrhythmias and subject-reported symptoms beta blockerivabradine usage dosechanges 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None