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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
This study compares the pacemaker's automatic pacing threshold measurements to the manual measurements conducted by a health care provider.
The purpose(s) of the study is (are) to evaluate several features available in EnPulse Series pacemaker and report the long term benefit of Atrial Capture Management (ACM) and Ventricular Capture Management (VCM) as demonstrated by accuracy in comparison with manual measurements and variability of ACM and VCM thresholds.
In addition, an evaluation of the timesaving and qualitative benefits of the device feature known as Quick Look II (the computer interface screen of the device programmer) will be measured through the use of a questionnaire completed by the health care professionals involved in patient follow-up care.
This is a one-to-one randomized, multicenter, prospective study in which patients receiving new EnPulse pacemaker implants will be randomized to each of three study arms, 1) routine manual follow-up and follow-up using the automatic features; 2) ACM diagnostics detail on or VCM diagnostics detail on; 3) PMOP on / off or PMOP off / on (6 month cycle).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pacemaker | Device |
| Measure | Description | Time Frame |
|---|---|---|
| The automatic device features Atrial Capture Management and Ventricular Capture Management measure pacing thresholds and is compared to manual pacing thresholds observed at the 6 month follow-up visit |
| Measure | Description | Time Frame |
|---|---|---|
| Observe the variability of multiple pacing thresholds measured with ACM and VCM | ||
| Observe visit time differences using automatic measurements versus traditional follow-up | ||
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Inclusion Criteria:
• Patients that meet ACC/AHA/NASPE 2002 class I or II dual chamber pacing indications (intended for a Pacing Mode programmed to DDD or DDDR)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen W. Mester, MD | Tampa General Hospital | Principal Investigator |
| Lawrence S. Rosenthal, MD | UMass Memorial Health | Principal Investigator |
| Raymond Gendreau, MD | Cite di la Sante de Laval | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anchorage | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20545869 | Derived | Rosenthal LS, Mester S, Rakovec P, Penaranda JB, Sherman JR, Sheldon TJ, Zeng C, Wang P; CAPTURE Trial Investigators. Factors influencing pacemaker generator longevity: results from the complete automatic pacing threshold utilization recorded in the CAPTURE Trial. Pacing Clin Electrophysiol. 2010 Aug;33(8):1020-30. doi: 10.1111/j.1540-8159.2010.02809.x. Epub 2010 Jun 2. |
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| Observe the effects of Post Mode Switch Overdrive Pacing (PMOP) on AT/AF burden. |
| Mobile |
| Alabama |
| United States |
| Fullerton | California | United States |
| Oceanside | California | United States |
| Redondo Beach | California | United States |
| Stanford | California | United States |
| Colorado Springs | Colorado | United States |
| Washington D.C. | District of Columbia | United States |
| Brandon | Florida | United States |
| Daytona Beach | Florida | United States |
| Orlando | Florida | United States |
| Sarasota | Florida | United States |
| Athens | Georgia | United States |
| Gainsville | Georgia | United States |
| Chicago | Illinois | United States |
| Peoria | Illinois | United States |
| Des Moines | Iowa | United States |
| Kansas City | Kansas | United States |
| Worcester | Maine | United States |
| Burlington | Massachusetts | United States |
| Petoskey | Michigan | United States |
| Saint Paul | Minnesota | United States |
| Jackson | Mississippi | United States |
| Columbia | Missouri | United States |
| St Louis | Missouri | United States |
| Flemington | New Jersey | United States |
| Newark | New Jersey | United States |
| Paramus | New Jersey | United States |
| Albuquerque | New Mexico | United States |
| Fayetteville | New York | United States |
| New York | New York | United States |
| High Point | North Carolina | United States |
| Akron | Ohio | United States |
| Cleveland | Ohio | United States |
| Steubenville | Ohio | United States |
| Lawton | Oklahoma | United States |
| Tualatin | Oregon | United States |
| Altoona | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| Pawtucket | Rhode Island | United States |
| Columbia | South Carolina | United States |
| Greenville | South Carolina | United States |
| Sioux Falls | South Dakota | United States |
| Knoxville | Tennessee | United States |
| Oak Ridge | Tennessee | United States |
| Forth Worth | Texas | United States |
| Houston | Texas | United States |
| Richmond | Virginia | United States |
| Spokane | Washington | United States |
| Charleston | West Virginia | United States |
| Wausau | Wisconsin | United States |
| North Vancouver | British Columbia | Canada |
| Kitchener | Ontario | Canada |
| Toronto | Ontario | Canada |
| Laval | Quebec | Canada |
| Québec | Quebec | Canada |
| Saskatoon | Saskatchewan | Canada |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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