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To evaluate whether atrial fibrillation (AF) therapies in Guidant Pulsar Max II or Insignia Plus DR have an effect on the occurance of AF in patients with no prior history of AF
This multi-centre, randomized, cross-over, prospective study will evaluate the occurrence of AF with AF pacing therapies programmed on (APP and VRR) and with AF therapies programmed off (APP and VRR) in patients with no known prior history of AF (all patients have a pacing indication). The occurrence of AF as well as time to first event and AF burden (frequecy and duration).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APP and VRR on | Experimental | APP and VRR turned on at 2 week visit |
|
| APP and VRR off | Active Comparator | APP and VRR turned off |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guidant Pulsar Max II or Insignia Plus DR | Device | market approved pacemaker. programmed per protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare the occurrence of AF (>350 bpm) during a period when AF pacing therapies are programmed on (APP and VRR) and during when AF therapies are programmed off. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| To compare AF burden between patients with AF therapies programmed on (APP and VRR) and patients with AF pacing therapies turned off (APP and VRR). Burden is defined as the product of the number of AF events and duration of events. To compare the time to | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence Sterns, MD | Victoria Cardiac Arrythmia trials | Principal Investigator |
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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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| Atrial pacing preference turned on or off | Device | programing changes in the device |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |