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| Name | Class |
|---|---|
| Applied Health Research Centre | OTHER |
| Biotronik Canada Inc | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VDD ICD | Experimental | 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 |
|
| VVI ICD | Active Comparator | VVI ICD - Single chamber ICD system - Control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VDD ICD (experimental group) | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eugene Crystal, MD, FRCP(C) | Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Alexandra Hospital | Edmonton | Alberta | T5H 3V9 | Canada | ||
| Vancouver Island Health Authority |
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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).
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|
|
| Single chamber VVI ICD (control group) | 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. |
|
|
| 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 |
| Vancouver |
| British Columbia |
| V8R 1J8 |
| Canada |
| Saint John Regional Hospital | Saint John | New Brunswick | E2L 4L4 | Canada |
| Health Sciences North | Greater Sudbury | Ontario | P3E 5J1 | Canada |
| Scarborough and Rouge Hospital - Centenary Site | Toronto | Ontario | M1E 4B9 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| IUCPQ - Institut universitaire de cardiologie et de pneumologie de Québec | Laval | Quebec | G1V 4G5 | Canada |
| HSCM - L'Hôpital du Sacré-Coeur de Montréal | Montreal | Quebec | H4J 1C5 | Canada |
| CHUS - Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | Quebec | J1H 5N4 | Canada |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D001281 | Atrial Fibrillation |
| D002318 | Cardiovascular Diseases |
| D001282 | Atrial Flutter |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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