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Preliminary analysis determined there was sufficient data to support objectives and allow early completion. The last patient visit occurred on November 6, 2007.
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The P3 Study is a United States post market study to gather data on clinical status, primary indications, device therapy choices, clinical management and outcomes for patients with implantable pacemakers.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dual Chamber Devices | Pacemaker device choice characterized by the number of patients with dual chamber devices | at original implant |
| Days Hospitalized | Healthcare utilization clinical outcome characterized by number of days hospitalized in the first year | implant to one year |
| Multiple In-clinic Visits | Follow-up practice pattern assessed by the number of patients with a dual chamber device that had two or more routine pacemaker in-clinic visits with a device interrogation | implant to one year |
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Inclusion Criteria:
Exclusion Criteria:
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Primary care clinic
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| Name | Affiliation | Role |
|---|---|---|
| Ravi Kanagala, MD | Franciscan Skemp Healthcare | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
Only patients who received an approved study device were enrolled in the registry.
Patients were enrolled in the study from March 2004 through April 2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pacing Patients | Patients implanted with a pacemaker. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Prescott |
| Arizona |
| United States |
| Little Rock | Arkansas | United States |
| Aliso Viejo | California | United States |
| Anaheim | California | United States |
| Arcadia | California | United States |
| Escondido | California | United States |
| Fountain Valley | California | United States |
| La Mesa | California | United States |
| Laguna Hills | California | United States |
| Mission Viejo | California | United States |
| Orange | California | United States |
| Riverside | California | United States |
| Tarzana | California | United States |
| Whittier | California | United States |
| Wildomar | California | United States |
| Denver | Colorado | United States |
| Fort Lauderdale | Florida | United States |
| Lauderdale Lakes | Florida | United States |
| Melbourne | Florida | United States |
| Ocala | Florida | United States |
| Sarasota | Florida | United States |
| Vero Beach | Florida | United States |
| Lawrenceville | Georgia | United States |
| Idaho Falls | Idaho | United States |
| Hinsdale | Illinois | United States |
| Moline | Illinois | United States |
| Hammond | Indiana | United States |
| Terre Haute | Indiana | United States |
| Hutchinson | Kansas | United States |
| Edgewood | Kentucky | United States |
| Owensboro | Kentucky | United States |
| Lafayette | Louisiana | United States |
| New Orleans | Louisiana | United States |
| Shreveport | Louisiana | United States |
| Scarborough | Maine | United States |
| Rockville | Maryland | United States |
| Boston | Massachusetts | United States |
| Cambridge | Massachusetts | United States |
| Alpena | Michigan | United States |
| Cleveland | Mississippi | United States |
| Moberly | Missouri | United States |
| Osage Beach | Missouri | United States |
| Saint Joseph | Missouri | United States |
| St Louis | Missouri | United States |
| Billings | Montana | United States |
| Kearney | Nebraska | United States |
| Omaha | Nebraska | United States |
| Bridgewater | New Jersey | United States |
| Clifton | New Jersey | United States |
| Elizabeth | New Jersey | United States |
| Galloway | New Jersey | United States |
| Elmira | New York | United States |
| Huntington | New York | United States |
| Charlotte | North Carolina | United States |
| Durham | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Cleveland Heights | Ohio | United States |
| Columbus | Ohio | United States |
| Dublin | Ohio | United States |
| Kettering | Ohio | United States |
| Lima | Ohio | United States |
| Lorain | Ohio | United States |
| Mayfield Heights | Ohio | United States |
| Middleburg Heights | Ohio | United States |
| Zanesville | Ohio | United States |
| Tulsa | Oklahoma | United States |
| Wakefield | Rhode Island | United States |
| Greenville | South Carolina | United States |
| Sumter | South Carolina | United States |
| Austin | Texas | United States |
| Beaumont | Texas | United States |
| Houston | Texas | United States |
| Humble | Texas | United States |
| Lubbock | Texas | United States |
| McAllen | Texas | United States |
| San Antonio | Texas | United States |
| Tomball | Texas | United States |
| Victoria | Texas | United States |
| Wichita Falls | Texas | United States |
| La Crosse | Wisconsin | United States |
| Waukesha | Wisconsin | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pacing Patients | Patients implanted with a pacemaker. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Dual Chamber Devices | Pacemaker device choice characterized by the number of patients with dual chamber devices | Posted | Number | Participants with dual chamber devices | at original implant |
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| Primary | Days Hospitalized | Healthcare utilization clinical outcome characterized by number of days hospitalized in the first year | Patients with a twelve-month follow-up visit were included in the analysis. | Posted | Mean | Standard Deviation | average days hospitalized | implant to one year |
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| Primary | Multiple In-clinic Visits | Follow-up practice pattern assessed by the number of patients with a dual chamber device that had two or more routine pacemaker in-clinic visits with a device interrogation | Only those patients with a dual chamber device completing 12 months of follow-up were included in this analysis. | Posted | Number | participants with 2 or more visits | implant to one year |
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Adverse events were not collected in the P3 Study. The products used in the study are market approved and were used within the indications for use as indicated in the product labeling.
Centers were instructed to report Unanticipated Adverse Device Events (UADE) in the same manner as required for any commercially available device, that is, through the Medical Device Reporting (MDR) processes and in accordance with any reporting requirements required by their IRB.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pacing Patients | Patients implanted with a pacemaker. | 0 | 0 | 0 | 0 |
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Characterization of objectives also encompassed 8 device features (Capture Management, MVP, APP, ARS, PMOP, Rate Response, Mode Switch, Sinus Preference) and 10 additional clinical outcomes. More information is available through the point of contact.
In most cases, contracts allow investigators to publish study results per the publication plan/protocol following Medtronic's review to determine whether confidential information ("CI") is disclosed. Any such CI is deleted prior to publication/presentation. Medtronic may not censor/interfere with the publication except as described. Investigators may not publish any single-site publications until the main multi-site study publication has occurred.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| P3 Study Team | Medtronic CRDM | 800-328-2518 | medtroniccrmtrials@medtronic.com |
| ID | Term |
|---|---|
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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