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.
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
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
188
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.
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.
Royal Alexandra Hospital
Edmonton, Alberta, Canada
Vancouver Island Health Authority
Vancouver, British Columbia, Canada
Saint John Regional Hospital
Saint John, New Brunswick, Canada
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.
Time frame: During the entire time of follow up - 3 years
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.
Time frame: 60 days
Pneumothorax
Composite outcome of serious device-related complications occurring in the 60 days from the time of ICD insertion.
Time frame: 60 days
New pericardial effusion
Composite outcome of serious device-related complications occurring in the 60 days from the time of ICD insertion.
Time frame: 60 days
Cardiac tamponade
Composite outcome of serious device-related complications occurring in the 60 days from the time of ICD insertion.
Time frame: 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.
Time frame: 60 days
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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