Recruiting

Observational Study

Sponsor:

Ottawa Heart Institute Research Corporation

Code:

NCT02808260

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Atrial fibrillation (AF) often starts with short episodes of rapid irregular heartbeats that are only detected by implanted pacemakers or defibrillators. Usually people don't know that they have these episodes. Over time, these episodes can happen more often and last for longer periods. In some people, the heart eventually remains permanently in a fast irregular rhythm, known as atrial fibrillation. This condition can lead to strokes and blood clots. If physicians could detect atrial fibrillation at a very early stage they could treat people early and possibly prevent the condition from becoming permanent. People with implanted devices allow a unique opportunity to constantly monitor the heart rhythm so investigators can detect any irregularities immediately.

Investigators don't know which people are at risk of developing short episodes of fast irregular heartbeats that can lead to atrial fibrillation. The purpose of this study is to find out if there are proteins or chemical changes in the blood that can predict the risk of developing atrial fibrillation. These chemical changes, also known as biomarkers, may also be able to give investigators other clues about atrial fibrillation.

Conditions

Atrial Fibrillation

Study ID

NCT02808260

Start date

Sep 1, 2022

Status verified date

Jul, 2026

Completion date

Sep, 2034

Anticipated

Primary completion date

Sep, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

• Dual chamber permanent pacemaker or defibrillator implanted within previous 10 years

Exclusion Criteria:

  • Clinical atrial fibrillation documented by surface ECG (12 lead ECG, Telemetry, Holter)
  • Participants considered by the investigator to be unsuitable for the study for the following reason: life expectancy less than 2 years due to concomitant disease
  • Participants who are pregnant or breast-feeding
  • Congenital heart disease
  • Inherited arrhythmia syndrome, i.e. Brugada, long QT interval

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • The development of new Sub-Clinical Atrial Fibrillation as recorded on implanted devices [ Time Frame: 11 years ]
  • Sub-clinical Atrial Fibrillation as predicted by biomarkers [ Time Frame: 11 years ]

Central Contacts and Locations

Central contacts

Locations

University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada, K1Y 4W7

Contacts

More Information

Sponsor

Ottawa Heart Institute Research Corporation

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • sub-clinical atrial fibrillation
  • biomarkers
  • implanted pacemaker or defibrillator

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Heart Institute Research Corporation on 2026-07-13.