Detection of Subclinical Atrial Fibrillation in High Risk Patients Using Implantable Loop Recorder

NCT ID: NCT02041832

Last Updated: 2016-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-09-30

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.

Conditions

Arterial Hypertension; Diabetes Mellitus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Holter monitoring

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

Group Type: OTHER

Conventional Holter monitoring

Intervention Type: OTHER

Patients undergo 72h Holter monitoring

Implantable loop recorder

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

Group Type: OTHER

Implantable loop recorder

Intervention Type: DEVICE

Implantation of loop recorder with follow-up by remote monitoring

Interventions

Conventional Holter monitoring

Patients undergo 72h Holter monitoring

Intervention Type: OTHER

Implantable loop recorder

Implantation of loop recorder with follow-up by remote monitoring

Intervention Type: DEVICE

Other Intervention Names

REVEAL XT

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Axel Brandes

OTHER

Sponsor Role: lead

Responsible Party

Axel Brandes

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Axel Brandes, Assoc. Prof.

Role: STUDY_DIRECTOR

Odense University Hospital/University of Southern Denmark

Locations

Haderslev Hospital

Haderslev, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 29759838 (View on PubMed)

Other Identifiers

S-20130062

Identifier Type: OTHER

Identifier Source: secondary_id

ILR-Afib-study

Identifier Type: -

Identifier Source: org_study_id