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


- candidate number28363
- NTR NumberNTR6910
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-dec-2017
- Secondary IDsNL63311.018.17 
- Public TitleAtrial Fibrillation in Patients With an Implantable Cardioverter Defibrillator and Coronary Artery Disease.
- Scientific TitleAtrial Fibrillation in Patients With an Implantable Cardioverter Defibrillator and Coronary Artery Disease.
- ACRONYMINDICO AF
- hypothesisTo investigate the incidence of new-onset AF in patients with coronary artery disease and an impaired LVEF, who will receive a single chamber ICD as primary prevention for sudden cardiac death.
- Healt Condition(s) or Problem(s) studiedAtrial Fibrillation, Coronary artery disease, Implantable cardiac device (ICD), Self-monitoring
- Inclusion criteria Age between 65 and 80 years
CAD, evident from a) previous myocardial infarction or b) revascularization through PCI or CABG
LVEF<35%, quantified on MRI or with nuclear imaging
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 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
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mrt-2018
- planned closingdate1-feb-2020
- Target number of participants50
- InterventionsPatients with CAD and
- Primary outcomethe percentage of patients with AF at 1 or 2 years.
- Secondary outcome1) 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.
- TimepointsStandard ICD interrogation will take place on a quarterly basis. The occurrence of AF will be monitored via remote monitoring and documented in the eCRF every month, during one year or until we reach an event rate of 10% and 20%.
- Trial web sitenone
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD, PhD J.R. Groot, de
- CONTACT for SCIENTIFIC QUERIESMD S.W.E. Baalman
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Medtronic
- Publications
- Brief summaryRationale: Post-myocardial infarction patients with reduced left ventricular ejection fraction (LVEF) are indicated for Implantable Cardioverter-Defibrillator (ICD) therapy as primary prevention for sudden cardiac death (SCD). Timely detection of atrial fibrillation (AF) in ICD patients is clinically important for appropriate treatment for prevention of AF related complications, most importantly stroke, heart failure and inappropriate ICD shocks. Patients with a two- or three chamber ICD and coronary artery disease (CAD) show a higher incidence of AF than age matched controls. If CAD patients with a single chamber ICD carry a similar risk for AF remains unknown. Recently, single chamber ICDs including algorithm based rhythm recorders are developed to investigate the incidence and prevalence of AF.

Objective: To investigate the incidence of new-onset AF in patients with CAD and an impaired LVEF, who will receive a single chamber ICD as primary prevention for SCD.

Study design: This study will be a multicentre observational study. Patients with CAD and
Study population: Patients, with CAD, LVEF <35% and without a history of AF, who are indicated for a single chamber ICD as primary prevention for SCD.

Intervention: Patients will, as per guideline recommendation, receive a single chamber ICD with an algorithm based rhythm recorder.

Main study parameters: Main study parameters are new-onset or silent AF.

The study with regard to a broader research plan: This study will underscore the importance of AF detection in single chamber ICD patients, remote patient monitoring and improvement of patient care. Thereby it may serve as a pilot study for upcoming large international trials on AF detection algorithm in patients with single chamber ICDs.
- Main changes (audit trail)
- RECORD19-dec-2017 - 8-jan-2018


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