To investigate the incidence of new-onset AF in patients with CAD and a single chamber ICD.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Incidence of new-onset AF in patients with CAD, LVEF <35 and no history of AF
with a single chamber ICD.
- The burden of AF in patients in whom we detect AF during this study.
Secondary outcome
- Time to an eventrate of 20% is reached.
- Determine if specific blood biomarkers reflecting different pathogenic
pathways in AF (fibrosis, oxidative stress and inflamtion), can be related tp
AF.
Background summary
Coronary artery disease (CAD) patients with reduced left ventricular ejection
fraction (LVEF) are indicated for Implantable Cardioverter Defibrillator (ICD)
therapy as 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 such as stroke
and inappropriate ICD shocks. Patients with a two- or three chamber ICD and CAD
show a higher incidence of AF. 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.
Study objective
To investigate the incidence of new-onset AF in patients with CAD and a single
chamber ICD.
Study design
This study will be a multicentre observational study. Patients with CAD, 35% and no history of AF will receive an single chamber ICD including an
algorithm based rhythm recorder. In combination with remote monitoring data
will be collected every month during 1 year or until an event rate of 20%.
Blood drawing and a twelve lead ECG will be made on the day of implantation and
during 6 and 12 months follow up, during standard ICD interoggation. All
patients in whom AF is documented will be invited for an outpatient visit and
will receive adequate anticoagulation treatment, when appropriate according to
CHADSVASc score.
Study burden and risks
The risk of AF in a population of patients with CAD and a reduced LVEF is high,
but the available data are derived from patients wit a two- or three chamber
ICD. It is likely that patients with CAD and a reduced LVEF recieving a single
chamber ICD for prevention of SCD carry a similar high risk for AF. Particpants
will recieve a single chamber ICD including an alghorythm based rhythm recorder
for the detection of AF. In order to detect AF, patients are asked to use the
patient unit once a month to send the stored data to the AMC. Follow-up of
patients will be performed in one of the participating centers at 6 and 12
months and every six months during standard ICD interrogation untill we reach
an event rate of 20%. .Participants will have potential benefit through the
early detection of AF and start of oral anticoagulation therapy.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL63311.018.17 |
OMON | NL-OMON28810 |