NCT03110627

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 51 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	VDD 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.
DEVICE	Single 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.

Timeline

• Start date: 2017-03-31
• Primary completion: 2022-03-31
• Completion: 2022-03-31
• First posted: 2017-04-12
• Last updated: 2021-04-30

Locations

9 sites across 1 country: Canada