P3: Pacemaker Patient Profiling Study

Bradycardia Clinical Trial

Official title:

Pacemaker Patient Profiling (P3) Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00294060
• Other study ID #: 244
• Status: Terminated
• Phase: N/A
• First received: February 16, 2006
• Last updated: April 6, 2011
• Start date: March 2004
• Est. completion date: November 2007

Study information

• Verified date: April 2011
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2013
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bradycardia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Dual Chamber Devices	Pacemaker device choice characterized by the number of patients with dual chamber devices	at original implant	No
Primary	Days Hospitalized	Healthcare utilization clinical outcome characterized by number of days hospitalized in the first year	implant to one year	No
Primary	Multiple In-clinic Visits	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	No