Increasing Detection of Sub-Clinical Atrial Fibrillation in Defibrillator Patients With the Use of a VDD-ICD Lead (Dx-AF)

Increasing Detection of Sub-Clinical Atrial Fibrillation in Defibrillator Patients With the Use of a VDD-ICD Lead

Increasing Detection of Sub-Clinical Atrial Fibrillation in Defibrillator Patients With the Use of a VDD-ICD Lead: The Dx-AF Study

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.

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.

Cardiac Arrhythmias, Atrial Fibrillation and Flutter, Cardiovascular Diseases, Implantable Cardioverter-Defibrillators

Single-chamber ICD (implantable cardioverter-defibrillator), Cardiac Arrhythmias, Atrial fibrillation, Atrial flutter, Stroke

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).

VDD ICD - A single-lead ICD system with the ability to sense atrial rhythm from the floating electrode (a VDD-ICD known as the DX) - 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.

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.

Atrial Fibrillation or atrial flutter lasting at least 6 minutes detected by the ICD, ECG, Holter monitor or telemetry.

Composite outcome of serious device-related complications occurring in the 60 days from the time of ICD insertion.

Composite outcome of serious device-related complications occurring in the 60 days from the time of ICD insertion.

Composite outcome of serious device-related complications occurring in the 60 days from the time of ICD insertion.

Composite outcome of serious device-related complications occurring in the 60 days from the time of ICD insertion.

Composite outcome of serious device-related complications occurring in the 60 days from the time of ICD insertion.

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