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

NCT ID: NCT03110627

Last Updated: 2021-04-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-31
• Study Completion Date: 2022-03-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

VDD ICD

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

Group Type: EXPERIMENTAL

VDD ICD (experimental group)

Intervention Type: DEVICE

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.

VVI ICD

VVI ICD - Single chamber ICD system - Control group

Group Type: ACTIVE_COMPARATOR

Single chamber VVI ICD (control group)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Experimental: DX ICD (experimental group); Control: Single chamber VVI ICD

Eligibility Criteria

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

• Minimum Eligible Age: 51 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Applied Health Research Centre

OTHER

Sponsor Role: collaborator

Biotronik Canada Inc

INDUSTRY

Sponsor Role: collaborator

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eugene Crystal, MD, FRCP(C)

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

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

Greater Sudbury, Ontario, Canada

Scarborough and Rouge Hospital - Centenary Site

Toronto, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

IUCPQ - Institut universitaire de cardiologie et de pneumologie de Québec

Laval, Quebec, Canada

HSCM - L'Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, Canada

CHUS - Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Countries

Canada

Other Identifiers

Dx01

Identifier Type: -

Identifier Source: org_study_id