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

Unity Health Toronto

Status: Unknown

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

Treatments: Device: Single chamber VVI ICD (control group); Device: VDD ICD (experimental group)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03110627

Dx01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 188 patients

Sex: All

Ages: 51+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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188 participants in 2 patient groups

VDD ICD

Experimental group

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

Treatment:

Device: VDD ICD (experimental group)

VVI ICD

Active Comparator group

Description:

VVI ICD - Single chamber ICD system - Control group

Treatment:

Device: Single chamber VVI ICD (control group)