Study Stopped
Preliminary analysis determined there was sufficient data to support objectives and allow early completion. The last patient visit occurred on November 6, 2007.
P3: Pacemaker Patient Profiling Study
Pacemaker Patient Profiling (P3) Study
1 other identifier
observational
2,013
1 country
83
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2004
Typical duration for all trials
83 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 16, 2006
CompletedFirst Posted
Study publicly available on registry
February 20, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedResults Posted
Study results publicly available
May 6, 2011
CompletedMay 6, 2011
April 1, 2011
3.7 years
February 16, 2006
July 1, 2009
April 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Eligibility Criteria
Primary care clinic
You may qualify if:
- Patient meets Class I / Class II indications for pacing
- Patient implanted with one of the following market-approved single or dual chamber Medtronic devices: EnRhythm™, EnPulse®, Kappa® 700, Kappa® 900, Vitatron Clarity™, Vitatron Selection® AFm, Vitatron C-Series, Vitatron T-Series, or the AT500™ DDDR Pacing System
You may not qualify if:
- Patient is enrolled in a device or cardiovascular drug study that affects treatment and/or study device programming
- Patient whose life expectancy is less than two years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (83)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Prescott, Arizona, United States
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Aliso Viejo, California, United States
Unknown Facility
Anaheim, California, United States
Unknown Facility
Arcadia, California, United States
Unknown Facility
Escondido, California, United States
Unknown Facility
Fountain Valley, California, United States
Unknown Facility
La Mesa, California, United States
Unknown Facility
Laguna Hills, California, United States
Unknown Facility
Mission Viejo, California, United States
Unknown Facility
Orange, California, United States
Unknown Facility
Riverside, California, United States
Unknown Facility
Tarzana, California, United States
Unknown Facility
Whittier, California, United States
Unknown Facility
Wildomar, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Fort Lauderdale, Florida, United States
Unknown Facility
Lauderdale Lakes, Florida, United States
Unknown Facility
Melbourne, Florida, United States
Unknown Facility
Ocala, Florida, United States
Unknown Facility
Sarasota, Florida, United States
Unknown Facility
Vero Beach, Florida, United States
Unknown Facility
Lawrenceville, Georgia, United States
Unknown Facility
Idaho Falls, Idaho, United States
Unknown Facility
Hinsdale, Illinois, United States
Unknown Facility
Moline, Illinois, United States
Unknown Facility
Hammond, Indiana, United States
Unknown Facility
Terre Haute, Indiana, United States
Unknown Facility
Hutchinson, Kansas, United States
Unknown Facility
Edgewood, Kentucky, United States
Unknown Facility
Owensboro, Kentucky, United States
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Lafayette, Louisiana, United States
Unknown Facility
New Orleans, Louisiana, United States
Unknown Facility
Shreveport, Louisiana, United States
Unknown Facility
Scarborough, Maine, United States
Unknown Facility
Rockville, Maryland, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Cambridge, Massachusetts, United States
Unknown Facility
Alpena, Michigan, United States
Unknown Facility
Cleveland, Mississippi, United States
Unknown Facility
Moberly, Missouri, United States
Unknown Facility
Osage Beach, Missouri, United States
Unknown Facility
Saint Joseph, Missouri, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Billings, Montana, United States
Unknown Facility
Kearney, Nebraska, United States
Unknown Facility
Omaha, Nebraska, United States
Unknown Facility
Bridgewater, New Jersey, United States
Unknown Facility
Clifton, New Jersey, United States
Unknown Facility
Elizabeth, New Jersey, United States
Unknown Facility
Galloway, New Jersey, United States
Unknown Facility
Elmira, New York, United States
Unknown Facility
Huntington, New York, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Durham, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Cleveland Heights, Ohio, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Dublin, Ohio, United States
Unknown Facility
Kettering, Ohio, United States
Unknown Facility
Lima, Ohio, United States
Unknown Facility
Lorain, Ohio, United States
Unknown Facility
Mayfield Heights, Ohio, United States
Unknown Facility
Middleburg Heights, Ohio, United States
Unknown Facility
Zanesville, Ohio, United States
Unknown Facility
Tulsa, Oklahoma, United States
Unknown Facility
Wakefield, Rhode Island, United States
Unknown Facility
Greenville, South Carolina, United States
Unknown Facility
Sumter, South Carolina, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Beaumont, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Humble, Texas, United States
Unknown Facility
Lubbock, Texas, United States
Unknown Facility
McAllen, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Tomball, Texas, United States
Unknown Facility
Victoria, Texas, United States
Unknown Facility
Wichita Falls, Texas, United States
Unknown Facility
La Crosse, Wisconsin, United States
Unknown Facility
Waukesha, Wisconsin, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- P3 Study Team
- Organization
- Medtronic CRDM
Study Officials
- STUDY CHAIR
Ravi Kanagala, MD
Franciscan Skemp Healthcare
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 16, 2006
First Posted
February 20, 2006
Study Start
March 1, 2004
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
May 6, 2011
Results First Posted
May 6, 2011
Record last verified: 2011-04