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

Not Applicable

• Conditions: Cardiac Arrhythmias; Implantable Cardioverter-Defibrillators; Cardiovascular Diseases; Atrial Fibrillation and Flutter
• Interventions: Device: VDD ICD (experimental group); Device: Single chamber VVI ICD (control group)

• Registration Number: NCT03110627
• Lead Sponsor: Unity Health Toronto

Brief 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.

Study Timeline

• Study Start: 2017-03-31
• Study First Submitted: 2017-04-07
• Study First Submitted QC: 2017-04-07
• Study First Posted: 2017-04-12
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-30
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 188

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VDD ICD	VDD ICD (experimental 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
VVI ICD	Single chamber VVI ICD (control group)	VVI ICD - Single chamber ICD system - Control group

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (9)

Royal Alexandra Hospital; 🇨🇦 Edmonton, Alberta, Canada

Vancouver Island Health Authority; 🇨🇦 Vancouver, British Columbia, Canada

Saint John Regional Hospital; 🇨🇦 Saint John, New Brunswick, Canada

Health Sciences North; 🇨🇦 Sudbury, Ontario, Canada

Scarborough and Rouge Hospital - Centenary Site; 🇨🇦 Toronto, Ontario, Canada

IUCPQ - Institut universitaire de cardiologie et de pneumologie de Québec; 🇨🇦 Laval, Quebec, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

HSCM - L'Hôpital du Sacré-Coeur de Montréal; 🇨🇦 Montreal, Quebec, Canada

CHUS - Centre Hospitalier Universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada