Registry for evaluating Medtronic products
Medtronic Product Surveillance Registry
This study is collecting information to see how safe and effective Medtronic products are for patients who are using them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100000 (estimated) |
| Sex | All |
| Sponsor | Medtronic Industry-sponsored |
| Locations | 391 sites (Birmingham, Alabama and 390 other locations) |
| Trial ID | NCT01524276 on ClinicalTrials.gov |
What this trial studies
This registry aims to continuously evaluate and report on the safety and effectiveness of Medtronic products that are already on the market. It collects data to support patients, hospitals, clinicians, and regulatory bodies by streamlining the clinical surveillance process. The registry allows for performance assessment of these products with minimal burden on participants. It includes patients who are currently receiving or are intended to receive eligible Medtronic products.
Who should consider this trial
Good fit: Ideal candidates include patients who are receiving or are intended to receive a Medtronic product and can provide consent.
Not a fit: Patients who are inaccessible for follow-up or are enrolled in conflicting studies may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could enhance patient safety and treatment outcomes by providing valuable data on Medtronic products.
How similar studies have performed: Other registries evaluating medical devices have shown success in improving patient outcomes and safety monitoring.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birmingham, Alabama and 390 other locations
- Birmingham, Alabama, United States (Recruiting)
- Huntsville, Alabama, United States (Recruiting)
- Chandler, Arizona, United States (Recruiting)
- Phoenix, Arizona, United States (Recruiting)
- Little Rock, Arkansas, United States (Recruiting)
- Aliso Viejo, California, United States (Recruiting)
- Chula Vista, California, United States (Recruiting)
- Colton, California, United States (Recruiting)
- La Jolla, California, United States (Recruiting)
- Los Angeles, California, United States (Recruiting)
- Napa, California, United States (Recruiting)
- Redwood City, California, United States (Recruiting)
- Salinas, California, United States (Recruiting)
- San Diego, California, United States (Recruiting)
- Stanford, California, United States (Recruiting)
- Torrance, California, United States (Recruiting)
- Ventura, California, United States (Recruiting)
- Aurora, Colorado, United States (Recruiting)
- Colorado Springs, Colorado, United States (Recruiting)
- Lakewood, Colorado, United States (Recruiting)
- Darien, Connecticut, United States (Recruiting)
- Hartford, Connecticut, United States (Recruiting)
- New Haven, Connecticut, United States (Recruiting)
- Washington D.C., District of Columbia, United States (Recruiting)
- Bradenton, Florida, United States (Recruiting)
- Clearwater, Florida, United States (Recruiting)
- Davie, Florida, United States (Recruiting)
- Jacksonville, Florida, United States (Recruiting)
- Naples, Florida, United States (Recruiting)
- Panama City, Florida, United States (Recruiting)
- Safety Harbor, Florida, United States (Recruiting)
- Sarasota, Florida, United States (Recruiting)
- Tampa, Florida, United States (Recruiting)
- Weston, Florida, United States (Recruiting)
- Gainesville, Georgia, United States (Active_not_recruiting)
- Chicago, Illinois, United States (Recruiting)
- Evansville, Indiana, United States (Recruiting)
- Indianapolis, Indiana, United States (Recruiting)
- Iowa City, Iowa, United States (Recruiting)
- West Des Moines, Iowa, United States (Recruiting)
- Kansas City, Kansas, United States (Recruiting)
- Edgewood, Kentucky, United States (Recruiting)
- Louisville, Kentucky, United States (Recruiting)
- New Orleans, Louisiana, United States (Recruiting)
- Hyattsville, Maryland, United States (Recruiting)
- Salisbury, Maryland, United States (Recruiting)
- Silver Spring, Maryland, United States (Recruiting)
- Boston, Massachusetts, United States (Recruiting)
- Holyoke, Massachusetts, United States (Recruiting)
- Ann Arbor, Michigan, United States (Recruiting)
+341 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Medtronic Product Surveillance Registry
- Email: rs.productsurveillanceregistry@medtronic.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.