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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02743520
Other study ID # 20150860
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 6, 2017
Est. completion date April 3, 2019

Study information

Verified date October 2020
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this research study is to learn about arrhythmia detection in obstructive sleep apnea (OSA). For several years patients with OSA have an increased likelihood of having irregular heartbeats. This study will determine how often patients with OSA have irregular heartbeats. This study will also define which OSA patients are most likely to have irregular heartbeats. The participant is being asked to be in the study because the participant has been diagnosed with obstructive sleep apnea (OSA).


Recruitment information / eligibility

Status Completed
Enrollment 86
Est. completion date April 3, 2019
Est. primary completion date April 3, 2019
Accepts healthy volunteers No
Gender All
Age group 40 Years to 85 Years
Eligibility Inclusion Criteria: 1. Diagnosis of OSA within the last 12 months 2. No previous diagnosis of atrial fibrillation 3. Able and willing to follow-up as an outpatient 4. Age 40-85 years Exclusion Criteria: 1. Life expectancy < 2 years 2. Dementia or other neurologic condition which would make outpatient follow-up difficult 3. CHADS score <2 4. Alcohol or drug abuse which would interfere with outpatient follow-up 5. Severe Congestive heart failure (NYHA class 3 or 4) or use of left ventricular assist device. 6. Current dialysis treatment or planned treatment within 12 months 7. Known bleeding disorder or prothrombin time >15 seconds 8. Mechanical heart valve requiring anticoagulation 9. Moderate to severe mitral stenosis or regurgitation 10. Prior clinical diagnosis of ischemic stroke (radiologic infarcts are not excluded) 11. Chronic obstructive pulmonary disease with oxygen dependence 12. Pregnant patients or patients that plan to become pregnant within the course of the study*. 13. Patients with anticipated need for a pacemaker during the course of the study *If any patients become pregnant during the course of the study, pregnancy outcomes will not be followed

Study Design


Intervention

Device:
The Lifestar Act III
The Lifestar Act III is a chest-worn continuous Electrocardiogram (ECG) monitor and arrhythmia detector. The device is equipped with four electrodes on a harness with a Bluetooth transceiver and a buzzer. The ECG signals will be transmitted via Bluetooth to an application arranged to process and transmit the ECG recordings.

Locations

Country Name City State
United States University of Miami Miami Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Miami Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Definite Atrial Fibrillation (Defined as an Irregularly Irregular Rhythm With Absence of p Waves) New cases of atrial fibrillation as evaluated by the LifestarAct III. Week 2
Secondary Number of Participants With Frequent Ventricular Premature Contractions More than 100 contraction during a 24 hour period as evaluated by the LifestarAct III. week 2
Secondary Longest Duration of Atrial Fibrillation Longest duration of Atrial Fibrillation in minutes compare to the rests of Atrial Fibrillation in a 24 hours, as evaluated by the LifestarAct III. Week 2
Secondary Atrial Fibrillation Episodes Lasting More Than Six Minutes In participants with atrial fibrillation as evaluated by the LifestarAct III. Week 2
Secondary The Number of Participants With Frequent Premature Atrial Contractions More than 100 contraction during a 24 hour period as evaluated by the LifestarAct III. Week 2
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