Recurrent Atrial Fibrillation

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: SEEQ monitor

• Registration Number: NCT02898545
• Lead Sponsor: University of Cincinnati

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.

Detailed 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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-08
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-13
• Status Verified: 2017-07
• Primary Completion: 2017-07-20
• Study Completion: 2017-07-20
• Last Update Submitted: 2017-07-28
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SEEQ monitor	SEEQ monitor	Subjects will be monitored via use of the SEEQ monitor

Primary Outcome Measures

Name	Time	Method
Recurrence of atrial fibrillation	28 days	The rate of recurrence of atrial fibrillation will be compared to the recurrence noted in the standard of care arm.

Trial Locations

Locations (1)

University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States