P3: Pacemaker Patient Profiling Study

April 6, 2011 updated by: Medtronic Cardiac Rhythm and Heart Failure

Pacemaker Patient Profiling (P3) Study

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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

2013

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Arizona
      • Prescott, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, 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
    • Colorado
      • Denver, Colorado, 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
    • Georgia
      • Lawrenceville, Georgia, United States
    • Idaho
      • Idaho Falls, Idaho, United States
    • Illinois
      • Hinsdale, Illinois, United States
      • Moline, Illinois, United States
    • Indiana
      • Hammond, Indiana, United States
      • Terre Haute, Indiana, United States
    • Kansas
      • Hutchinson, Kansas, United States
    • Kentucky
      • Edgewood, Kentucky, United States
      • Owensboro, Kentucky, United States
    • Louisiana
      • Lafayette, Louisiana, United States
      • New Orleans, Louisiana, United States
      • Shreveport, Louisiana, United States
    • Maine
      • Scarborough, Maine, United States
    • Maryland
      • Rockville, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • Cambridge, Massachusetts, United States
    • Michigan
      • Alpena, Michigan, United States
    • Mississippi
      • Cleveland, Mississippi, United States
    • Missouri
      • Moberly, Missouri, United States
      • Osage Beach, Missouri, United States
      • St. Joseph, Missouri, United States
      • St. Louis, Missouri, United States
    • Montana
      • Billings, Montana, United States
    • Nebraska
      • Kearney, Nebraska, United States
      • Omaha, Nebraska, United States
    • New Jersey
      • Bridgewater, New Jersey, United States
      • Clifton, New Jersey, United States
      • Elizabeth, New Jersey, United States
      • Galloway, New Jersey, United States
    • New York
      • Elmira, New York, United States
      • Huntington, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
      • Durham, North Carolina, United States
    • Ohio
      • 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
    • Oklahoma
      • Tulsa, Oklahoma, United States
    • Rhode Island
      • Wakefield, Rhode Island, United States
    • South Carolina
      • Greenville, South Carolina, United States
      • Sumter, South Carolina, 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
    • Wisconsin
      • LaCrosse, Wisconsin, United States
      • Waukesha, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at original implant
Days Hospitalized
Time Frame: implant to one year
Healthcare utilization clinical outcome characterized by number of days hospitalized in the first year
implant to one year
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
implant to one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Investigators

  • Study Chair: Ravi Kanagala, MD, Franciscan Skemp Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

February 16, 2006

First Submitted That Met QC Criteria

February 16, 2006

First Posted (Estimate)

February 20, 2006

Study Record Updates

Last Update Posted (Estimate)

May 6, 2011

Last Update Submitted That Met QC Criteria

April 6, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 244

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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