Atrial Fibrillation and Flutter, Cardiac Arrhythmias, Cardiovascular Diseases, Implantable Cardioverter-Defibrillators
Conditions
Keywords
Single-chamber ICD (implantable cardioverter-defibrillator), Cardiac Arrhythmias, Atrial fibrillation, Atrial flutter, Stroke
Brief summary
This study aims to compare the Dx-ICD system (experimental) to standard VVI-ICD (control) on the ability to diagnose silent AF in patients without prior AF receiving an ICD for standard indications.
Detailed description
Recipients of implantable defibrillators (ICD) are at high risk of developing both AF and stroke, given the presence of multiple cardiovascular risk factors. Oral anticoagulation can prevent most strokes in patients with AF; provided that AF is recognized before a stroke occurs. Up to about 40% of incident AF may be sub-clinical, producing minimal or no symptoms, or being too short to allow detection. DX AF is a prospective, randomized-controlled, open-label trial. Patients who are identified on clinical grounds for a single-chamber ICD will be randomized to a VDD ICD (experimental group) or single chamber ICD (control group). The study will compare the Dx-ICD system (experimental) to standard VVI-ICD (control) on the ability to diagnose silent AF in patients without prior AF receiving an ICD for standard indications.
Interventions
DEVICEVDD ICD (experimental group)
Patients who are identified on clinical grounds for a single-chamber ICD will randomized to a VDD ICD (experimental group) or single chamber ICD (control group). The study will compare the Dx-ICD system (experimental) to standard VVI-ICD (control) on the ability to diagnose silent AF in patients without prior AF receiving an ICD for standard indications.
DEVICESingle chamber VVI ICD (control group)
Patients who are identified on clinical grounds for a single-chamber ICD will randomized to a VDD ICD (experimental group) or single chamber ICD (control group). The study will compare the Dx-ICD system (experimental) to standard VVI-ICD (control) on the ability to diagnose silent AF in patients without prior AF receiving an ICD for standard indications.
Sponsors
Applied Health Research Centre
Biotronik Canada Inc
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
DX AF is a prospective, randomized-controlled, open-label trial. Patients who are identified on clinical grounds for a single-chamber ICD will randomized to a VDD ICD (experimental group) or single chamber ICD (control group).
Eligibility
Sex/Gender
ALL
Age
51 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with ischemic or non-ischemic cardiomyopathy, * LVEF\<50%, scheduled for primary or secondary prevention ICD * Treating physicians feel that the use of single chamber ICD is appropriate * No ECG-documented history of AF or flutter * Age \> 50 years
Exclusion criteria
* Known AF or flutter * Current use of class I or III anti-arrhythmic medications * Participants unwilling to attend study follow-up visits, considered unreliable for compliance or with an anticipated life expectancy less than 3 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Atrial Fibrillation or atrial flutter lasting at least 6 minutes | During the entire time of follow up - 3 years | Atrial Fibrillation or atrial flutter lasting at least 6 minutes detected by the ICD, ECG, Holter monitor or telemetry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for any ICD lead repositioning or replacement | 60 days | Composite outcome of serious device-related complications occurring in the 60 days from the time of ICD insertion. |
| Pneumothorax | 60 days | Composite outcome of serious device-related complications occurring in the 60 days from the time of ICD insertion. |
| New pericardial effusion | 60 days | Composite outcome of serious device-related complications occurring in the 60 days from the time of ICD insertion. |
| Cardiac tamponade | 60 days | Composite outcome of serious device-related complications occurring in the 60 days from the time of ICD insertion. |
| Procedure-related death or wound infection | 60 days | Composite outcome of serious device-related complications occurring in the 60 days from the time of ICD insertion. |
Countries
Canada
Outcome results
None listed