NCT01524276 · Medtronic
Product Surveillance Registry
(PSR)
What this study is about
The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Birmingham, Alabama
- Huntsville, Alabama
- Chandler, Arizona
- Phoenix, Arizona
- Little Rock, Arkansas
- Aliso Viejo, California
- Chula Vista, California
- Colton, California
- La Jolla, California
- Los Angeles, California
- Napa, California
- Redwood City, California
And 122 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 17, 2026 · Source of record for eligibility and locations