MedPath

INDICO AF - Atrial Fibrillation in patients with an implantable cardioverter defibrillator and coronary artery disease.

Completed
Conditions
Atrial Fibrillation
irregular heartbeat
10007521
Registration Number
NL-OMON55649
Lead Sponsor
Academisch Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
50
Inclusion Criteria

• Age between 18 and 80 years
• CAD, evident from a) previous myocardial infarction or b) revascularization
through PCI or CABG
• LVEF<35%, quantified on MRI, with nuclear imaging or determined by
echocardiography
• Willing and able to sign informed consent and to comply with the protocol and
with the follow-up
• Life expectancy > 2 years

Exclusion Criteria

• Unwilling to sign informed consent
• Current atrial fibrillation
• A history of atrial fibrillation not including postoperative atrial
fibrillation
• Previous catheter or surgical ablation for atrial fibrillation
• Current use or current indication 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
• Being pregnant or of child bearing potential
• Life expectancy<2 years

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>- Incidence of new-onset AF in patients with CAD, LVEF <35 and no history of AF<br /><br>with a single chamber ICD.<br /><br>- The burden of AF in patients in whom we detect AF during this study.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>- Time to an eventrate of 20% is reached.<br /><br>- Determine if specific blood biomarkers reflecting different pathogenic<br /><br>pathways in AF (fibrosis, oxidative stress and inflamtion), can be related tp<br /><br>AF.</p><br>
© Copyright 2025. All Rights Reserved by MedPath