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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; Implantable Cardioverter-Defibrillators; Cardiac Arrhythmias; Atrial Fibrillation and Flutter
• Intervention / Treatment: Device: VDD ICD (experimental group); Device: Single chamber VVI ICD (control group)

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 Type: Interventional
• Enrollment (Actual): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5H 3V9
      • Royal Alexandra Hospital
  • British Columbia
    • Vancouver, British Columbia, Canada, V8R 1J8
      • Vancouver Island Health Authority
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 4L4
      • Saint John Regional Hospital
  • Ontario
    • Sudbury, Ontario, Canada, P3E 5J1
      • Health Sciences North
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada, M1E 4B9
      • Scarborough and Rouge Hospital - Centenary Site
  • Quebec
    • Laval, Quebec, Canada, G1V 4G5
      • IUCPQ - Institut universitaire de cardiologie et de pneumologie de Québec
    • Montreal, Quebec, Canada, H4J 1C5
      • HSCM - L'Hôpital du Sacré-Coeur de Montréal
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • CHUS - Centre hospitalier universitaire de Sherbrooke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.; Other Names: Experimental: DX ICD (experimental group)
Active Comparator: VVI ICD; VVI ICD - Single chamber ICD system - Control group	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.; Other Names: Control: Single chamber VVI ICD

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Collaborators: Applied Health Research Centre; Biotronik Canada Inc
• Investigators: Principal Investigator: Eugene Crystal, MD, FRCP(C), Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2017
• Primary Completion (Anticipated): March 31, 2022
• Study Completion (Anticipated): March 31, 2022

Study Registration Dates

• First Submitted: April 7, 2017
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Stroke; Atrial fibrillation; Single-chamber ICD (implantable cardioverter-defibrillator); Cardiac Arrhythmias; Atrial flutter
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Atrial Fibrillation; Arrhythmias, Cardiac
• Other Study ID Numbers: DX01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No