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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02898545
Other study ID # 2015-2478
Secondary ID
Status Completed
Phase N/A
First received September 8, 2016
Last updated July 28, 2017
Start date September 2016
Est. completion date July 20, 2017

Study information

Verified date July 2017
Source University of Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Eligible individuals with no previous history of atrial fibrillation or flutter who develop a limited episode of atrial fibrillation during a hospital stay for an acute medical illness or non-cardiothoracic surgery or procedure. Patients will be monitored for a period of 1 month using Medtronic SEEQ monitors for recurrence. Subjects will self assign to wear the SEEQ monitor or standard of care. Individuals with implanted cardiac devices capable of detecting atrial fibrillation will also be included.


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date July 20, 2017
Est. primary completion date July 20, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
SEEQ monitor
An external cardiac rhythm monitor

Locations

Country Name City State
United States University of Cincinnati Medical Center Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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