Clinical trial NCT03110627: Increasing Detection of Sub-Clinical Atrial Fibrillation in Defibrillator Patients With the Use of a VDD-ICD Lead
Official title: Increasing Detection of Sub-Clinical Atrial Fibrillation in Defibrillator Patients With the Use of a VDD-ICD Lead: The Dx-AF Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Arrhythmias
Atrial Fibrillation and Flutter
Cardiovascular Diseases
Implantable Cardioverter-Defibrillators
Keywords: Single-chamber ICD (implantable cardioverter-defibrillator)
Cardiac Arrhythmias
Atrial fibrillation
Atrial flutter
Stroke
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Applied Health Research Centre
name: Biotronik Canada Inc
First posted: 2017-04-12
Enrollment: 188
Sex: ALL
Minimum age (years): 51
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: DX AF is a prospective, randomized-controlled, open-label trial. 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).
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Atrial Fibrillation or atrial flutter lasting at least 6 minutes
timeFrame: During the entire time of follow up - 3 years
Secondary outcomes:
measure: Need for any ICD lead repositioning or replacement
timeFrame: 60 days
measure: Pneumothorax
timeFrame: 60 days
measure: New pericardial effusion
timeFrame: 60 days
measure: Cardiac tamponade
timeFrame: 60 days
measure: Procedure-related death or wound infection
timeFrame: 60 days
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver Island Health Authority
state: British Columbia
city: Saint John
country: Canada
facility: Saint John Regional Hospital
state: New Brunswick
city: Sudbury
country: Canada
facility: Health Sciences North
state: Ontario
city: Toronto
country: Canada
facility: Scarborough and Rouge Hospital - Centenary Site
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Laval
country: Canada
facility: IUCPQ - Institut universitaire de cardiologie et de pneumologie de Québec
state: Quebec
city: Montreal
country: Canada
facility: HSCM - L'Hôpital du Sacré-Coeur de Montréal
state: Quebec
city: Sherbrooke
country: Canada
facility: CHUS - Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Eugene Crystal, MD, FRCP(C)
role: PRINCIPAL_INVESTIGATOR
References: