P3: Pacemaker Patient Profiling Study

This study has been terminated.
(Preliminary analysis determined there was sufficient data to support objectives and allow early completion. The last patient visit occurred on November 6, 2007.)
Sponsor:
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00294060
First received: February 16, 2006
Last updated: April 6, 2011
Last verified: April 2011
  Purpose

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
Bradycardia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pacemaker Patient Profiling (P3) Study

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Number of Participants With Dual Chamber Devices [ Time Frame: at original implant ] [ Designated as safety issue: No ]
    Pacemaker device choice characterized by the number of patients with dual chamber devices

  • Days Hospitalized [ Time Frame: implant to one year ] [ Designated as safety issue: No ]
    Healthcare utilization clinical outcome characterized by number of days hospitalized in the first year

  • Multiple In-clinic Visits [ Time Frame: implant to one year ] [ Designated as safety issue: No ]
    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


Enrollment: 2013
Study Start Date: March 2004
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294060

  Hide Study Locations
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, 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
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 Disease Management
Investigators
Study Chair: Ravi Kanagala, MD Franciscan Skemp Healthcare
  More Information

No publications provided

Responsible Party: P3 Study Team, Medtronic CRDM
ClinicalTrials.gov Identifier: NCT00294060     History of Changes
Other Study ID Numbers: 244
Study First Received: February 16, 2006
Results First Received: July 1, 2009
Last Updated: April 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Pacemaker
Bradycardia

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

ClinicalTrials.gov processed this record on September 18, 2014