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

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • VDD ICD (experimental group) Device
    Other Names: Experimental: DX ICD (experimental group)
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: VDD ICD
    Description: 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
  • Single chamber VVI ICD (control group) Device
    Other Names: Control: Single chamber VVI ICD
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: VVI ICD
    Description: VVI ICD - Single chamber ICD system - Control group

Outcomes

Type Measure Time Frame Safety Issue
Primary Atrial Fibrillation or atrial flutter lasting at least 6 minutes During the entire time of follow up - 3 years
Secondary Need for any ICD lead repositioning or replacement 60 days
Secondary Pneumothorax 60 days
Secondary New pericardial effusion 60 days
Secondary Cardiac tamponade 60 days
Secondary Procedure-related death or wound infection 60 days

Sponsors