Overview

This trial is active, not recruiting.

Condition atrial fibrillation
Treatment seeq monitor
Phase phase 0
Sponsor University of Cincinnati
Start date August 2016
End date August 2018
Trial size 40 participants
Trial identifier NCT02898545, 2015-2478

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose screening
Arm
(Other)
Subjects will be monitored via use of the SEEQ monitor
seeq monitor
An external cardiac rhythm monitor
(No Intervention)
Subjects will not wear the SEEQ monitor or may have a pre-existing implanted device capable of detecting atrial fibrillation

Primary Outcomes

Measure
Recurrence of atrial fibrillation
time frame: 28 days

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Recurrent Atrial Fibrillation
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Cincinnati.