Predicting Development of SCAF in Device Patients

NCT02808260 | Recruiting

• 1 other identifier: 20160338
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• The development of new Sub-Clinical Atrial Fibrillation as recorded on implanted devices

  Participants will be monitored by clinical follow up for a year and then medical record reviews for an additional 10 years

  11 years

• Sub-clinical Atrial Fibrillation as predicted by biomarkers

  Biomarkers will be measured at baseline and after 1 year to see if biomarkers can predict which people will develop sub-clinical atrial fibrillation during the 11 year follow up period

  11 years

Secondary Outcomes (1)

• The development of clinical atrial fibrillation, including persistent atrial fibrillation.

  11 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Investigators will recruit patients with a permanent defibrillator or pacemaker who have an upcoming appointment at the Device Clinic.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead
• Genome Canada: collaborator

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be collected for the measurement of biomarkers

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pablo Nery, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tammy Knight

CONTACT

613-696-7000; tknight@ottawaheart.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: June 21, 2016
• Study Start: September 1, 2022
• Primary Completion (Estimated): September 1, 2034
• Study Completion (Estimated): September 1, 2034
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)