INDICO AF - Atrial Fibrillation in patients with an implantable cardioverter defibrillator and coronary artery disease.
- Conditions
- Atrial Fibrillationirregular heartbeat10007521
- 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
• 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
• 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
Name Time Method <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
Name Time Method <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>