Prevalence of Sub-Clinical Atrial Fibrillation Using an Implantable Cardiac Monitor

NCT01694394 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 256

Last updated 2018-08-31

No results posted yet for this study

Summary

The primary objective of the study is to determine the rate of detection of sub-clinical atrial fibrillation (≥ 5 minutes)within an average of 12 months following implant of the St. Jude Medical Confirm(R) Implantable Cardiac Monitor in patients with known cardiovascular risk factors and left atrial enlargement, but without prior AF.

Conditions

Interventions

DEVICE

Implantable Cardiac Monitor (Confirm ICM model 2102)

Patients who meet the study criteria will be implanted with a St. Jude Medical Confirm Implantable Cardiac Monitor (Confirm ICM) model 2102 or other St. Jude Medical ICM with the same capabilities.

Sponsors & Collaborators

  • Abbott Medical Devices

    collaborator INDUSTRY
  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV
  • Population Health Research Institute

    lead OTHER

Principal Investigators

  • Jeff Healey, M.D. · Population Health Research Institute

  • Stuart Connolly, M.D. · Population Health Research Institute

  • Marco Alings, M.D. · Working group Cardiovascular research Netherlands

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2016-07-31
Completion
2016-10-31

Countries

  • Canada
  • Netherlands

Study Locations

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Entities

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 NCT01694394 on ClinicalTrials.gov