P3: Pacemaker Patient Profiling Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00294060
Recruitment Status : Terminated (Preliminary analysis determined there was sufficient data to support objectives and allow early completion. The last patient visit occurred on November 6, 2007.)
First Posted : February 20, 2006
Results First Posted : May 6, 2011
Last Update Posted : May 6, 2011
Information provided by:
Medtronic Cardiac Rhythm and Heart Failure

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.

Condition or disease

Study Type : Observational
Actual Enrollment : 2013 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pacemaker Patient Profiling (P3) Study
Study Start Date : March 2004
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Primary Outcome Measures :
  1. Number of Participants With Dual Chamber Devices [ Time Frame: at original implant ]
    Pacemaker device choice characterized by the number of patients with dual chamber devices

  2. Days Hospitalized [ Time Frame: implant to one year ]
    Healthcare utilization clinical outcome characterized by number of days hospitalized in the first year

  3. Multiple In-clinic Visits [ Time Frame: implant to one year ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00294060

  Hide Study Locations
United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Prescott, Arizona, United States
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
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
United States, Colorado
Denver, Colorado, United States
United States, Florida
Ft. 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
United States, Georgia
Lawrenceville, Georgia, United States
United States, Idaho
Idaho Falls, Idaho, United States
United States, Illinois
Hinsdale, Illinois, United States
Moline, Illinois, United States
United States, Indiana
Hammond, Indiana, United States
Terre Haute, Indiana, United States
United States, Kansas
Hutchinson, Kansas, United States
United States, Kentucky
Edgewood, Kentucky, United States
Owensboro, Kentucky, United States
United States, Louisiana
Lafayette, Louisiana, United States
New Orleans, Louisiana, United States
Shreveport, Louisiana, United States
United States, Maine
Scarborough, Maine, United States
United States, Maryland
Rockville, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
Cambridge, Massachusetts, United States
United States, Michigan
Alpena, Michigan, United States
United States, Mississippi
Cleveland, Mississippi, United States
United States, Missouri
Moberly, Missouri, United States
Osage Beach, Missouri, United States
St. Joseph, Missouri, United States
St. Louis, Missouri, United States
United States, Montana
Billings, Montana, United States
United States, Nebraska
Kearney, Nebraska, United States
Omaha, Nebraska, United States
United States, New Jersey
Bridgewater, New Jersey, United States
Clifton, New Jersey, United States
Elizabeth, New Jersey, United States
Galloway, New Jersey, United States
United States, New York
Elmira, New York, United States
Huntington, New York, United States
United States, North Carolina
Charlotte, North Carolina, United States
Durham, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
Cleveland Heights, Ohio, United States
Cleveland, 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
United States, Oklahoma
Tulsa, Oklahoma, United States
United States, Rhode Island
Wakefield, Rhode Island, United States
United States, South Carolina
Greenville, South Carolina, United States
Sumter, South Carolina, United States
United States, Texas
Austin, Texas, United States
Beaumont, Texas, United States
Houston, Texas, United States
Humble, Texas, United States
Lubbock, Texas, United States
Mc Allen, Texas, United States
San Antonio, Texas, United States
Tomball, Texas, United States
Victoria, Texas, United States
Wichita Falls, Texas, United States
United States, Wisconsin
LaCrosse, Wisconsin, United States
Waukesha, Wisconsin, United States
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Study Chair: Ravi Kanagala, MD Franciscan Skemp Healthcare

Responsible Party: P3 Study Team, Medtronic CRDM Identifier: NCT00294060     History of Changes
Other Study ID Numbers: 244
First Posted: February 20, 2006    Key Record Dates
Results First Posted: May 6, 2011
Last Update Posted: May 6, 2011
Last Verified: April 2011

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes