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

  Show 83 Study Locations
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