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 and Heart Failure
ClinicalTrials.gov Identifier:
NCT00294060
First received: February 16, 2006
Last updated: April 6, 2011
Last verified: April 2011

February 16, 2006
April 6, 2011
March 2004
November 2007   (final data collection date for primary outcome measure)
  • 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
Not Provided
Complete list of historical versions of study NCT00294060 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
P3: Pacemaker Patient Profiling Study
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Primary care clinic
Bradycardia
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2013
November 2007
November 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00294060
244
No
Not Provided
Not Provided
P3 Study Team, Medtronic CRDM
Medtronic Cardiac Rhythm and Heart Failure
Not Provided
Study Chair: Ravi Kanagala, MD Franciscan Skemp Healthcare
Medtronic Cardiac Rhythm and Heart Failure
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP