NCT02898545

Brief Summary

This study will evaluate the recurrence rates of atrial fibrillation that develops in the hospital following non cardiac procedures or surgeries or acute medical illnesses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable atrial-fibrillation

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

September 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2017

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

11 months

First QC Date

September 8, 2016

Last Update Submit

July 28, 2017

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Recurrence of atrial fibrillation

    The rate of recurrence of atrial fibrillation will be compared to the recurrence noted in the standard of care arm.

    28 days

Study Arms (2)

SEEQ monitor

OTHER

Subjects will be monitored via use of the SEEQ monitor

Device: SEEQ monitor

Standard of care

NO INTERVENTION

Subjects will not wear the SEEQ monitor or may have a pre-existing implanted device capable of detecting atrial fibrillation

Interventions

SEEQ monitorDEVICE

An external cardiac rhythm monitor

SEEQ monitor

Eligibility Criteria

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

You may qualify if:

  • Development of atrial fibrillation or flutter during a hospital stay following a non-cardiac procedure or acute medical illness
  • CHADS2VASc score of 2 or more

You may not qualify if:

  • Prior history of atrial fibrillation of flutter
  • Requiring ventilator support or in shock
  • Acute decompensated heart failure or EF =/\< 40%
  • Greater than mild valvular heart disease
  • Other structural heart disease such as more than mild LVH, constrictive or restrictive cardiomyopathy
  • Hyperthyroidism uncontrolled at the time of diagnosis if known
  • Pulmonary embolism that requires thrombolysis or resulted in shock
  • Use of antiarrhythmic drugs (class I or III) at the time of discharge
  • Cardiothoracic surgery in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mehran Attari, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 8, 2016

First Posted

September 13, 2016

Study Start

September 1, 2016

Primary Completion

July 20, 2017

Study Completion

July 20, 2017

Last Updated

August 1, 2017

Record last verified: 2017-07

Locations

US(1)