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| Name | Class |
|---|---|
| Sorin Group Canada | INDUSTRY |
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The aims of this study are to assess the clinical benefits resulting from SafeR by comparison with standard dual chamber programming (DDD) with a long atrioventricular (AV) delay.
The benefits will be assessed by comparing the percentage of ventricular pacing, the incidence of atrial arrhythmias, and the evolution of the hemodynamic status as observed through echo parameter and atrial natriuretic peptide/brain natriuretic peptide (ANP/BNP) measurements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DDD long AV delay | No Intervention | Pacemaker is programmed in DDD mode with long AV delay (250 msec) | |
| AAI SafeR | Active Comparator | Pacemaker is programmed in AAI SafeR mode |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pacing mode | Device | To determine which mode (DDD vs AAI SafeR)minimizes ventricular pacing |
|
| Measure | Description | Time Frame |
|---|---|---|
| to evaluate the effectiveness of SafeR | 1 and 3 years | |
| preserve natural AV conduction compared to DDD Long AVD | 1 and 3 years | |
| demonstrate the effectiveness of SafeR to reduce AF incidence on a LT basis | 1 and 3 years | |
| compare the effects of SafeR vs DDD Long AVD on LV function | 1 and 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| total mortality | 1 and 3 years | |
| CHF-related mortality & hospitalisations | 1 and 3 years | |
| evolution of systemic BP |
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Inclusion Criteria:
Exclusion Criteria:
The patients presenting with one or more of the following characteristics cannot be included:
Permanent complete AV block
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| Name | Affiliation | Role |
|---|---|---|
| Bernard Thibault, MD | Montreal Heart Institute, Research Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Alexandra Hospital | Edmonton | Alberta | T5H 3V9 | Canada | ||
| Grey Nuns Hospital, Edmonton |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| 1 and 3 years |
| AF-related AEs | 1 and 3 years |
| evolution of cardiac asynchrony [interventricular (RV-LV) & intraventricular (4 segments) | 1 and 3 years |
| Edmonton |
| Alberta |
| T6L 5X8 |
| Canada |
| Kingston Hospital, Queens University | Kingston | Ontario | K7L 2V7 | Canada |
| Southlake Regional Hospital | Newmarket | Ontario | L3Y 2P9 | Canada |
| St Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| Institut Universitaire de Cardiologie et de Pneumologie | Québec | Quebec | G1V 4G5 | Canada |
| Hôtel-Dieu de St Jérome | Saint Jérome | Quebec | J7Z 5T3 | Canada |
| Centre hospitalier régional de Trois-Rivières | Trois-Rivières | Quebec | G8Z 3R9 | Canada |
| Royal University Hospital, Saskatoon | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| D013568 |
| Pathological Conditions, Signs and Symptoms |