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Atrial Fibrillation in Patients With an Implantable Cardioverter Defibrillator and Coronary Artery Disease.

Atrial Fibrillation in Patients With an Implantable Cardioverter Defibrillator and Coronary Artery Disease.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28810
Enrollment
50
Registered
2017-12-19
Start date
2018-03-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation, implantable cardioverter defibrillator, home monitoring, coronary artery disease.

Interventions

Patients with CAD and <LVEF 35% have a guideline indication for ICD therapy and will receive a single chamber ICD with an algorithm based rhythm recorder.

Sponsors

Academic Medical Center (AMC) Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Age between 65 and 80 years • CAD, evident from a) previous myocardial infarction or b) revascularization through PCI or CABG • LVEF 2 years

Exclusion criteria

Exclusion criteria: • Unwilling or unable to comply with the protocol • Unwilling to sign informed consent • Current atrial fibrillation • A history of atrial fibrillation • Previous catheter or surgical ablation for atrial fibrillation • Use of vitamin K antagonist or NOACs • Use of class 1 or 3 antiarrhythmic drugs for ventricular or supraventricular arrhythmia ` other than AF • Prosthetic heart valves • Dilated or hypertrophic cardiomyopathy • Congenital heart disease for which surgical correction was performed • Inherited arrhythmia syndrome • Active malignant disease • Use of antracyclins in the history • History of TIA, stroke or systemic embolism • Being pregnant or of child bearing potential • Life expectancy<2 years

Design outcomes

Primary

MeasureTime frame
the percentage of patients with AF at 1 or 2 years.

Secondary

MeasureTime frame
1) the time to 10% and 20% of patients with AF. 2) The burden as percentage/day of AF. 3) Occurrence of TIA, stroke or systemic embolism. 4) Cumulative incidence of appropriate and inappropriate ICD therapy.

Contacts

Public ContactJ.R. Groot, de

Academic Medical Center-University of Amsterdam, F3-234

j.r.degroot@amc.uva.nl020-5669111 (tracer 58921)

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)