Maestro Handheld Cardiac Monitor Validation | NCT02977104

Studies
Maestro Handheld Cardiac Monitor Validation

NCT02977104

Sponsor

University of Michigan

Status

Completed

Last Update Posted

Dec 8, 2017Actual

Enrollment

70Actual

Phase

Not Applicable

Conditions

Cardiac Arrhythmia

Interventions

Maestro ECG

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2013Actual

Primary Completion Date

Dec 5, 2017Actual

Completion Date

Dec 5, 2017Actual

First Submitted Date

Nov 16, 2016

First Submission Date that Met QC Criteria

Nov 27, 2016

First Posted Date

Nov 30, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2017

Last Update Posted Date

Dec 8, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to demonstrate that the Maestro hand held heart monitor can accurately diagnose Atrial Fibrillation, atrial flutter or normal sinus rhythm in patients.

Detailed Description

The purpose of this study is to determine if Maestro can be used to detect heart arrhythmias, specifically atrial fibrillation in humans. Maestro will be used to measure heart rate and rhythm at the same time that patients are being monitored with a standard 3, 5, or 12 lead electrocardiogram (ECG) in a clinical setting. The recorded Maestro results will be compared to the ECG results to assess Maestro's accuracy.

Data will be analyzed by a pass/fail criterial. The data will be downloaded and printed for the investigators' interpretation who will first review and code the data from Meastro, blinded to the ECG findings. Then the investigators will interpret the ECG findings and the 2 sets of data will be compared. The ECG result is the true value with which to compare the Maestro result.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients in afib or flutter	Other	Maestro ECG	Other: Maestro ECG
Patients in sinus rhythm	Other	Maestro ECG	Other: Maestro ECG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Maestro ECG	Other	Telemetry is obtained through the Maestro handheld ECG device.	Patients in afib or flutter Patients in sinus rhythm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity and Specificity of atrial fibrillation detection	Each sample acquired by the Maestro system will be automatically analyzed and rhythm categorized by the automated algorithm. This will then be assessed for accuracy and sensitivity and specificity for detection of atrial fibrillation will be calculated.	6 seconds

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ability to provide informed consent

Exclusion Criteria:

implanted pacemakers
open wounds or abrasions on their hands
prior damage to hands or thumbs precluding obtaining an ECG tracing

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rakesh Latchamsetty, MD	University of Michigan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Michigan Cardiovascular Center		Ann Arbor	Michigan	48109	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001145	Arrhythmias, Cardiac

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided