NCT02977104

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2017

Completed
Last Updated

December 8, 2017

Status Verified

December 1, 2017

Enrollment Period

4.4 years

First QC Date

November 16, 2016

Last Update Submit

December 6, 2017

Conditions

Cardiac Arrhythmia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Patients in afib or flutter

OTHER

Maestro ECG

Other: Maestro ECG

Patients in sinus rhythm

OTHER

Maestro ECG

Other: Maestro ECG

Interventions

Maestro ECGOTHER

Telemetry is obtained through the Maestro handheld ECG device.

Patients in afib or flutterPatients in sinus rhythm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ability to provide informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Cardiovascular Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rakesh Latchamsetty, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 40 subjects with Atrial Fibrillation 10 subjects with Atrial Flutter 20 subjects with Sinus Rhythm
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 16, 2016

First Posted

November 30, 2016

Study Start

July 1, 2013

Primary Completion

December 5, 2017

Study Completion

December 5, 2017

Last Updated

December 8, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)