Recruiting

Observational StudyProduct Surveillance Registry

Sponsor:

Medtronic

Code:

NCT01524276

Conditions

Cardiac Rhythm Disorders

Urological Disorders

Neurological Disorders

Cardiovascular Disorders

Digestive Disorders

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.

Conditions

Cardiac Rhythm Disorders

Urological Disorders

Neurological Disorders

Cardiovascular Disorders

Digestive Disorders

Study ID

NCT01524276

Start date

Jan, 2012

Status verified date

Dec, 2025

Completion date

Jan, 2040

Anticipated

Primary completion date

Jan, 2040

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
Patient has or is intended to receive or be treated with an eligible Medtronic product
Patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment

Exclusion Criteria:

Patient who is, or will be, inaccessible for follow-up
Patient with exclusion criteria required by local law
Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results

Study Design

Enrollment

100000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

Safety and Effectiveness of Market Released products [ Time Frame: Every 6-12 months (Therapy-dependent) ]

Central Contacts and Locations

Central contacts

Medtronic Product Surveillance Registry

rs.productsurveillanceregistry@medtronic.com

Locations

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Birmingham, Alabama, United States

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Huntsville, Alabama, United States

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Chandler, Arizona, United States

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Phoenix, 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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Chula Vista, California, United States

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Colton, California, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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Napa, California, United States

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Redwood City, California, United States

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Salinas, California, United States

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San Diego, California, United States

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Stanford, California, United States

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Torrance, California, United States

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Ventura, California, United States

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Aurora, Colorado, United States

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Colorado Springs, Colorado, United States

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Lakewood, Colorado, United States

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Darien, Connecticut, United States

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Hartford, Connecticut, United States

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New Haven, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Bradenton, Florida, United States

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Clearwater, Florida, United States

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Davie, Florida, United States

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Jacksonville, Florida, United States

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Naples, Florida, United States

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Panama City, Florida, United States

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Safety Harbor, Florida, United States

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Sarasota, Florida, United States

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Tampa, Florida, United States

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Weston, Florida, United States

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Chicago, Illinois, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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Iowa City, Iowa, United States

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West Des Moines, Iowa, United States

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Kansas City, Kansas, United States

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Edgewood, Kentucky, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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Hyattsville, Maryland, United States

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Salisbury, Maryland, United States

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Silver Spring, Maryland, United States

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Boston, Massachusetts, United States

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Holyoke, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Bay City, Michigan, United States

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Lansing, Michigan, United States

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Rochester Hills, Michigan, United States

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Ypsilanti, Michigan, United States

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Coon Rapids, Minnesota, United States

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Minneapolis, Minnesota, United States

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Robbinsdale, Minnesota, United States

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Rochester, Minnesota, United States

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Columbia, Missouri, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Camden, New Jersey, United States

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Marlton, New Jersey, United States

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Morristown, New Jersey, United States

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Ocean Township, New Jersey, United States

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Teaneck, New Jersey, United States

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Albuquerque, New Mexico, United States

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Albany, New York, United States

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Bay Shore, New York, United States

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Huntington, New York, United States

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Manhasset, New York, United States

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Mount Kisco, New York, United States

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New Hyde Park, New York, United States

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New York, New York, United States

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Port Jefferson, New York, United States

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Poughkeepsie, New York, United States

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Riverhead, New York, United States

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Staten Island, New York, United States

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Stony Brook, New York, United States

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Utica, New York, United States

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Chapel Hill, North Carolina, United States

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Charleston, North Carolina, United States

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Durham, North Carolina, United States

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Edenton, North Carolina, United States

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Pinehurst, North Carolina, United States

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Raleigh, North Carolina, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Mount Orab, Ohio, United States

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Portland, Oregon, United States

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Allentown, Pennsylvania, United States

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Bethlehem, Pennsylvania, United States

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Danville, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Mechanicsburg, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Wilkes-Barre, Pennsylvania, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Orangeburg, South Carolina, United States

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Spartanburg, South Carolina, United States

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Sioux Falls, South Dakota, United States

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Germantown, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Grapevine, Texas, United States

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Houston, Texas, United States

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Kyle, Texas, United States

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Plano, Texas, United States

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San Antonio, Texas, United States

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Tyler, Texas, United States

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Salt Lake City, Utah, United States

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Burlington, Vermont, United States

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Charlottesville, Virginia, United States

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Fairfax, Virginia, United States

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Falls Church, Virginia, United States

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Fredericksburg, Virginia, United States

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Bremerton, Washington, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Morgantown, West Virginia, United States

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Madison, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Calgary, Alberta, Canada

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Kingston, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Québec, Canada

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Toronto, Canada

More Information

Sponsor

Medtronic

Last update posted

Aug 18, 2026

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medtronic on 2026-08-18.