Clinical trial NCT00294060: P3: Pacemaker Patient Profiling Study
Official title: Pacemaker Patient Profiling (P3) Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Bradycardia
Keywords: Pacemaker
Bradycardia
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2006-02-20
Enrollment: 2013
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief 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.


Eligibility 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

Primary outcomes:
measure: Number of Participants With Dual Chamber Devices
timeFrame: at original implant
measure: Days Hospitalized
timeFrame: implant to one year
measure: Multiple In-clinic Visits
timeFrame: implant to one year
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Prescott
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Aliso Viejo
country: United States
state: California
city: Anaheim
country: United States
state: California
city: Arcadia
country: United States
state: California
city: Escondido
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: La Mesa
country: United States
state: California
city: Laguna Hills
country: United States
state: California
city: Mission Viejo
country: United States
state: California
city: Orange
country: United States
state: California
city: Riverside
country: United States
state: California
city: Tarzana
country: United States
state: California
city: Whittier
country: United States
state: California
city: Wildomar
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Ft. Lauderdale
country: United States
state: Florida
city: Lauderdale Lakes
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Vero Beach
country: United States
state: Florida
city: Lawrenceville
country: United States
state: Georgia
city: Idaho Falls
country: United States
state: Idaho
city: Hinsdale
country: United States
state: Illinois
city: Moline
country: United States
state: Illinois
city: Hammond
country: United States
state: Indiana
city: Terre Haute
country: United States
state: Indiana
city: Hutchinson
country: United States
state: Kansas
city: Edgewood
country: United States
state: Kentucky
city: Owensboro
country: United States
state: Kentucky
city: Lafayette
country: United States
state: Louisiana
city: New Orleans
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Scarborough
country: United States
state: Maine
city: Rockville
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Cambridge
country: United States
state: Massachusetts
city: Alpena
country: United States
state: Michigan
city: Cleveland
country: United States
state: Mississippi
city: Moberly
country: United States
state: Missouri
city: Osage Beach
country: United States
state: Missouri
city: St. Joseph
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Billings
country: United States
state: Montana
city: Kearney
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Bridgewater
country: United States
state: New Jersey
city: Clifton
country: United States
state: New Jersey
city: Elizabeth
country: United States
state: New Jersey
city: Galloway
country: United States
state: New Jersey
city: Elmira
country: United States
state: New York
city: Huntington
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland Heights
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Dublin
country: United States
state: Ohio
city: Kettering
country: United States
state: Ohio
city: Lima
country: United States
state: Ohio
city: Lorain
country: United States
state: Ohio
city: Mayfield Heights
country: United States
state: Ohio
city: Middleburg Heights
country: United States
state: Ohio
city: Zanesville
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Wakefield
country: United States
state: Rhode Island
city: Greenville
country: United States
state: South Carolina
city: Sumter
country: United States
state: South Carolina
city: Austin
country: United States
state: Texas
city: Beaumont
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Humble
country: United States
state: Texas
city: Lubbock
country: United States
state: Texas
city: Mc Allen
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Tomball
country: United States
state: Texas
city: Victoria
country: United States
state: Texas
city: Wichita Falls
country: United States
state: Texas
city: LaCrosse
country: United States
state: Wisconsin
city: Waukesha
country: United States
state: Wisconsin
Study officials:
affiliation: Franciscan Skemp Healthcare
name: Ravi Kanagala, MD
role: STUDY_CHAIR
References: