NCT02041832

Brief Summary

Using implantable loop recorder the investigators wish to detect atrial fibrillation in high risk patients and compare it to the results using conventional Holter monitoring. The hypothesis is that 10-15% of high risk patients have subclinical atrial fibrillation. The investigators want to detect those people so they can receive appropriate anticoagulation treatment. The patients will get a comprehensive workup including ecg, echocardiography and blood tests.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 22, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 28, 2016

Status Verified

September 1, 2016

Enrollment Period

2.9 years

First QC Date

November 28, 2013

Last Update Submit

September 27, 2016

Conditions

Arterial HypertensionDiabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • First episode of atrial fibrillation

    1 year

Secondary Outcomes (1)

  • Correlation between echocardiographic parameters and incidence of atrial fibrillation

    1 year

Other Outcomes (1)

  • Correlation between biomarkers and incidence of atrial fibrillation

    1 year

Study Arms (2)

Holter monitoring

OTHER

Screening of patients with older age, arterial hypertension and diabetes for paroxysmal atrial fibrillation by using conventional Holter monitoring

Other: Conventional Holter monitoring

Implantable loop recorder

OTHER

Screening of patients with older age, arterial hypertension and diabetes mellitus for paroxysmal atrial fibrillation by using an implantable loop recorder

Device: Implantable loop recorder

Interventions

Conventional Holter monitoringOTHER

Patients undergo 72h Holter monitoring

Holter monitoring
Implantable loop recorderDEVICE

Implantation of loop recorder with follow-up by remote monitoring

Also known as: REVEAL XT
Implantable loop recorder

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • age \> 65 years
  • arterial hypertension (at least dual treatment)
  • diabetes mellitus (oral antidiabetics or insulin)

You may not qualify if:

  • known atrial fibrillation
  • ischaemic heart disease
  • Current anticoagulation treatment
  • Ejection fraction \<45 %
  • significant valvular heart disease
  • previous stroke/transient ischemic attack
  • peripheral arterial disease
  • end stage renal disease
  • thyreotoxicosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haderslev Hospital

Haderslev, 6100, Denmark

Location

Related Publications (1)

  • Philippsen TJ, Christensen LS, Hansen MG, Dahl JS, Brandes A. Detection of Subclinical Atrial Fibrillation in High-Risk Patients Using an Insertable Cardiac Monitor. JACC Clin Electrophysiol. 2017 Dec 26;3(13):1557-1564. doi: 10.1016/j.jacep.2017.06.020. Epub 2017 Nov 6.

    PMID: 29759838DERIVED

MeSH Terms

Conditions

HypertensionDiabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Axel Brandes, Assoc. Prof.

    Odense University Hospital/University of Southern Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 28, 2013

First Posted

January 22, 2014

Study Start

October 1, 2013

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 28, 2016

Record last verified: 2016-09

Locations

DK(1)