Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Atrial Fibrillation
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Atrial fibrillation (AF) is considered to be a progressive condition that starts with episodes of paroxysmal AF (short runs of AF), progresses to persistent AF (can be reverted to normal rhythm) and eventually to permanent AF. More than 25% of people with paroxysmal AF will go on to develop persiste...

Atrial fibrillation (AF) is considered to be a progressive condition that starts with episodes of paroxysmal AF (short runs of AF), progresses to persistent AF (can be reverted to normal rhythm) and eventually to permanent AF. More than 25% of people with paroxysmal AF will go on to develop persistent or chronic atrial fibrillation. The progression rate is around 5% per annum. AF can result in devastating outcomes such as stroke/TIA and systemic embolic events. In people with implanted devices such as ICDs, investigators can detect non-symptomatic rapid atrial arrhythmia, known as subclinical atrial fibrillation (SCAF), before it becomes symptomatic. In the ASSERT trial, SCAF was detected in 10% of patients with newly implanted devices within the first 3 months. Of these, nearly 16% developed clinical atrial fibrillation within 2.5 years vs 3% in those who did not exhibit SCAF within the first 3 months. During the follow up period, a further 24.5% of patients developed SCAF. People with SCAF also had a higher risk of stroke and systemic embolism. Earlier diagnosis and treatment of AF may lead to better prevention and outcomes. The availability of serum based biomarkers that can predict the early onset of atrial fibrillation, may help in the identification of patients at risk for developing AF early. This would also allow the identification of the patient population most suitable for the evaluation of possible future intervention strategies to prevent the onset of atrial fibrillation, and alter its natural history and complications. In this study investigators will study patients that have a new permanent pacemaker or defibrillator implanted. These devices continuously monitor the patient's heart rhythm, detecting any irregularities. Patients with these devices are followed up in outpatient clinics on a regular basis. The information from the devices is downloaded at each follow up visit and analyzed by staff in the clinic. Investigators will recruit patients for this study 4 weeks after the device was implanted. After obtaining consent, investigators will collect a blood sample for measuring biomarkers. They will interview the participant in regards to previous health history, smoking, alcohol consumption, family history and current medications. Investigators will measure the blood pressure and heart rate. After one year when the participant returns for a clinical follow up visit, another blood sample will be drawn for biomarkers. Any irregular heart rhythms that were detected on the implanted device will be recorded. Investigators will also ask the participant in regards to any illnesses and hospitalizations during the past year. Participants' medical records will be reviewed annually for the next 10 years, to monitor for any irregular heart rhythms, hospitalizations and death.

Tracking Information

NCT #
NCT02808260
Collaborators
Genome Canada
Investigators
Principal Investigator: Peter Liu, MD Ottawa Heart Institute Research Corporation