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Benefits of µCor in Ambulatory Decompensated Heart Failure

NCT03476187 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 257

Last updated 2025-01-08

Study results available
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Summary

Subjects meeting the inclusion/exclusion criteria will wear the µCor for at least 90 days. During the study, clinic follow up will occur every 30 days. For all subjects, each scheduled clinic visit will include assessment of cardiac symptoms and any relevant clinically actionable events. The subject will be given a daily diary to track symptoms, unplanned hospital visits, medication changes, and all other heart failure related clinical events. Weekly phone calls to the subject will be given throughout the duration of the study to remind the patient to use the subject diary and to collect and record heart failure related clinical events. Subjects will be contacted six months and one year from initial enrollment to assess the vital status of the subject, any heart failure related clinical events since the end of µCor wear, and any health care utilization since the end of µCor wear.

Conditions

Interventions

DEVICE

µCor

Monitor with µCor

Sponsors & Collaborators

  • Zoll Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Steven J. Szymkiewicz, MD · Zoll Medical Corporation

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-17
Primary Completion
2024-01-08
Completion
2024-04-09
FDA Device
Yes

Countries

  • United States
  • Austria
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03476187 on ClinicalTrials.gov