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Subclinical Postoperative Atrial Fibrillation

NCT02522364 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2017-10-19

No results posted yet for this study

Summary

Postoperative atrial fibrillation and atrial flutter (POAF) is the most common complication after cardiac surgery requiring intervention or prolonged hospital stay.

POAF is associated with higher mortality and higher risk of thromboembolic events.

However, It is yet unknown whether a now event of postoperative atrial fibrillation is an indication of a chronic arrhythmic disease - a tendency towards developing recurrent atrial fibrillation or merely a response to the stress of surgery with not recurrence. This distinction is critical to determine the appropriate therapy. Since recurred events of atrial fibrillation (Paroxysmal atrial fibrillation) are associated with long term risk for stroke and thromboembolic evens patients with PAF are treated with long term anticoagulation. Missing the long term recurrence of arrhythmia may result in under-treatment and pose a significant risk of stroke.

Bio-Monitor is a subcutaneous implanted device that automatically detects arrhythmias and stores electrocardiogram (ECG) recordings. It will enable the detection of atrial fibrillation over a period of years and allow correct diagnosis and appropriate treatment.

The purpose of the study is to study the long term behavior of POAF, determine the likelihood of developing paroxysmal atrial fibrillation in patients with POAF and to define the risk factors for this eventuality

Conditions

Interventions

DEVICE

BioMonitor device

Implantation of a BioMonitor device and continuously monitoring heart rhythm for study duration

OTHER

Standard

Clinical and intermittent electrocardiographic follow-up of patients

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Principal Investigators

  • Michael Glikson, MD · Sheba Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-12-31
Completion
2019-12-31

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02522364 on ClinicalTrials.gov