P3: Pacemaker Patient Profiling Study

NCT ID: NCT00294060

Last Updated: 2011-05-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

2013 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-03-31

Study Completion Date

2007-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Bradycardia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Responsible Party

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Medtronic CRDM

Principal Investigators

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Ravi Kanagala, MD

Role: STUDY_CHAIR

Franciscan Skemp Healthcare

Locations

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Birmingham, Alabama, United States

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Prescott, Arizona, United States

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Little Rock, Arkansas, United States

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Aliso Viejo, California, United States

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Anaheim, California, United States

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Arcadia, California, United States

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Escondido, California, United States

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Fountain Valley, California, United States

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La Mesa, California, United States

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Laguna Hills, California, United States

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Mission Viejo, California, United States

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Orange, California, United States

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Riverside, California, United States

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Tarzana, California, United States

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Whittier, California, United States

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Wildomar, California, United States

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Denver, Colorado, United States

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Fort Lauderdale, Florida, United States

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Lauderdale Lakes, Florida, United States

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Melbourne, Florida, United States

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Ocala, Florida, United States

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Sarasota, Florida, United States

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Vero Beach, Florida, United States

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Lawrenceville, Georgia, United States

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Idaho Falls, Idaho, United States

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Hinsdale, Illinois, United States

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Moline, Illinois, United States

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Hammond, Indiana, United States

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Terre Haute, Indiana, United States

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Hutchinson, Kansas, United States

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Edgewood, Kentucky, United States

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Owensboro, Kentucky, United States

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Lafayette, Louisiana, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, United States

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Scarborough, Maine, United States

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Rockville, Maryland, United States

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Boston, Massachusetts, United States

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Cambridge, Massachusetts, United States

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Alpena, Michigan, United States

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Cleveland, Mississippi, United States

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Moberly, Missouri, United States

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Osage Beach, Missouri, United States

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Saint Joseph, Missouri, United States

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St Louis, Missouri, United States

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Billings, Montana, United States

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Kearney, Nebraska, United States

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Omaha, Nebraska, United States

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Bridgewater, New Jersey, United States

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Clifton, New Jersey, United States

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Elizabeth, New Jersey, United States

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Galloway, New Jersey, United States

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Elmira, New York, United States

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Huntington, New York, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Cleveland Heights, Ohio, United States

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Columbus, Ohio, United States

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Dublin, Ohio, United States

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Kettering, Ohio, United States

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Lima, Ohio, United States

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Lorain, Ohio, United States

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Mayfield Heights, Ohio, United States

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Middleburg Heights, Ohio, United States

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Zanesville, Ohio, United States

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Tulsa, Oklahoma, United States

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Wakefield, Rhode Island, United States

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Greenville, South Carolina, United States

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Sumter, South Carolina, United States

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Austin, Texas, United States

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Beaumont, Texas, United States

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Houston, Texas, United States

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Humble, Texas, United States

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Lubbock, Texas, United States

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McAllen, Texas, United States

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San Antonio, Texas, United States

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Tomball, Texas, United States

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Victoria, Texas, United States

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Wichita Falls, Texas, United States

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La Crosse, Wisconsin, United States

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Waukesha, Wisconsin, United States

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Countries

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United States

Other Identifiers

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244

Identifier Type: -

Identifier Source: org_study_id

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