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

Cardiovascular Diseases Clinical Trial

— Dx-AF  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03110627
• Other study ID #: Dx01
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 31, 2017
• Est. completion date: March 31, 2022

Study information

• Verified date: April 2021
• Source: Unity Health Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 188
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 51 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Royal Alexandra Hospital	Edmonton	Alberta
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	Saint John Regional Hospital	Saint John	New Brunswick
Canada	CHUS - Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	Health Sciences North	Sudbury	Ontario
Canada	Scarborough and Rouge Hospital - Centenary Site	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Vancouver Island Health Authority	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Unity Health Toronto	Applied Health Research Centre, Biotronik Canada Inc

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Pneumothorax	Composite outcome of serious device-related complications occurring in the 60 days from the time of ICD insertion.	60 days
Secondary	New pericardial effusion	Composite outcome of serious device-related complications occurring in the 60 days from the time of ICD insertion.	60 days
Secondary	Cardiac tamponade	Composite outcome of serious device-related complications occurring in the 60 days from the time of ICD insertion.	60 days
Secondary	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