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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: VDD ICD (experimental group)
* Device: Single chamber VVI ICD (control group)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 51 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VDD ICD<br>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 | Device: VDD ICD (experimental group)<br>* 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.<br>* Other names: Experimental: DX ICD (experimental group);|
| Active Comparator: VVI ICD<br>VVI ICD - Single chamber ICD system - Control group | Device: Single chamber VVI ICD (control group)<br>* 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.<br>* Other names: Control: Single chamber VVI ICD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial Fibrillation or atrial flutter lasting at least 6 minutes | Atrial Fibrillation or atrial flutter lasting at least 6 minutes detected by the ICD, ECG, Holter monitor or telemetry. | During the entire time of follow up - 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for any ICD lead repositioning or replacement | Composite outcome of serious device-related complications occurring in the 60 days from the time of ICD insertion. | 60 days | 
| Pneumothorax | Composite outcome of serious device-related complications occurring in the 60 days from the time of ICD insertion. | 60 days | 
| New pericardial effusion | Composite outcome of serious device-related complications occurring in the 60 days from the time of ICD insertion. | 60 days | 
| Cardiac tamponade | Composite outcome of serious device-related complications occurring in the 60 days from the time of ICD insertion. | 60 days | 
| Procedure-related death or wound infection | Composite outcome of serious device-related complications occurring in the 60 days from the time of ICD insertion. | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Single-chamber ICD (implantable cardioverter-defibrillator), Cardiac Arrhythmias, Atrial fibrillation, Atrial flutter, Stroke