ClinicalTrials.gg
RecruitingNCT01524276PSRUpdated Oct 20, 2026

Product Surveillance Registry

An observational study in Cardiac Rhythm Disorders, Urological Disorders and Neurological Disorders, sponsored by Medtronic. Recruiting at 402 sites in 41 countries. Per ClinicalTrials.gov, last updated 2026-10-20.

Primary conditionRenal InsufficiencyRegistry: Urologic DiseasesReclassifiedWhy we changed it
Registry
Urologic Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Renal Insufficiency
Why
  1. The study's listed conditions name Renal Insufficiency, a narrower term within Urologic Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Medtronic · Observational

Updated Oct 20, 20265 sites added4 sites removedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100,000
Sex
All
01

Study 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.

02

Conditions studied

  • Cardiac Rhythm Disorders
  • Urological Disorders
  • Neurological Disorders
  • Cardiovascular Disorders
  • Digestive Disorders
  • Intracranial Aneurysm
  • Mechanical Circulatory Support
  • Respiratory Therapy
  • Aortic, Peripheral Vascular and Venous Disorders
  • Minimally Invasive Surgical Procedures
  • Diagnostic Techniques and Procedures
  • Surgical Procedures, Operative
  • Renal Insufficiency
  • Neurovascular
  • Coronary Artery Disease
  • Ear, Nose and Throat Disorder
03

In context

Renal Insufficiency Reclassified

1,409 studies on the registry are indexed under Renal Insufficiency; 143 are open to participants now.

This study's planned enrollment of 100,000 is above the median of 178 across 292 observational studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Medtronic is the lead sponsor of 42 studies on the registry; 5 are open to participants now.

Compared within Renal Insufficiency, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Urologic Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects implanted with Medtronic qualifying therapy product.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100,000 participants (estimated)
06

What researchers measure

Primary outcomes

  1. Safety and Effectiveness of Market Released products

    Time frame: Every 6-12 months (Therapy-dependent)

07

Study locations

381 of 402 sites recruiting
  • 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
  • Temecula, 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

    Not enrolling at this site — choose another above.

  • 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
  • Bay City, Michigan, United States
    Recruiting
  • Lansing, Michigan, United States
    Recruiting
  • Rochester Hills, Michigan, United States
    Recruiting
  • Ypsilanti, Michigan, United States
    Recruiting
  • Coon Rapids, Minnesota, United States
    Recruiting
  • Minneapolis, Minnesota, United States
    Recruiting
  • Robbinsdale, Minnesota, United States
    Recruiting
  • Rochester, Minnesota, United States
    Recruiting
  • Saint Cloud, Minnesota, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Jackson, Mississippi, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Columbia, Missouri, United States
    Recruiting
  • Kansas City, Missouri, United States
    Recruiting
  • St Louis, Missouri, United States
    Recruiting
  • Omaha, Nebraska, United States
    Recruiting
  • Reno, Nevada, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Lebanon, New Hampshire, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Camden, New Jersey, United States
    Recruiting
  • Marlton, New Jersey, United States
    Recruiting
  • Morristown, New Jersey, United States
    Recruiting
  • Ocean Township, New Jersey, United States
    Recruiting
  • Teaneck, New Jersey, United States
    Recruiting
  • Albuquerque, New Mexico, United States
    Recruiting
  • Albany, New York, United States
    Recruiting
  • Bay Shore, New York, United States
    Recruiting
  • Huntington, New York, United States
    Recruiting
  • Manhasset, New York, United States
    Recruiting
  • Mount Kisco, New York, United States
    Recruiting
  • New Hyde Park, New York, United States
    Recruiting
  • New York, New York, United States
    Recruiting
  • Port Jefferson, New York, United States
    Recruiting
  • Poughkeepsie, New York, United States
    Recruiting
  • Riverhead, New York, United States
    Recruiting
  • Roslyn, New York, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Staten Island, New York, United States
    Recruiting
  • Stony Brook, New York, United States
    Recruiting
  • Utica, New York, United States
    Recruiting
  • Chapel Hill, North Carolina, United States
    Recruiting
  • Charleston, North Carolina, United States
    Recruiting
  • Durham, North Carolina, United States
    Recruiting
  • Edenton, North Carolina, United States
    Recruiting
  • Pinehurst, North Carolina, United States
    Recruiting
  • Raleigh, North Carolina, United States
    Recruiting
  • Cleveland, Ohio, United States
    Recruiting
  • Columbus, Ohio, United States
    Recruiting
  • Dayton, Ohio, United States
    Recruiting
  • Mount Orab, Ohio, United States
    Recruiting
  • Portland, Oregon, United States
    Recruiting
  • Allentown, Pennsylvania, United States
    Recruiting
  • Bethlehem, Pennsylvania, United States
    Recruiting

Showing the first 100 of 402 sites across 41 countries. Choose a country and city above to see the rest.

08

References and documents

Publications

  • Wu V, Makary MS, Tarter W, Elsaadany A, Shrestha P. Real-World Safety and Performance of Nylon and PGLA Fibered Detachable Coils in Peripheral Embolization: A Prospective Multicenter Registry. J Vasc Interv Radiol. 2026 Jul 14:108959. doi: 10.1016/j.jvir.2026.108959. Online ahead of print. PubMed 42448174 ↗
  • Quyn A, Navarro A, Caldonazo T, Findlay JM, Doenst T, Anderson M, Gong X, Botman JMJ. Real-World Performance of the Veriset Hemostatic Patch: A Multicenter Study of Adjunctive Hemostasis. Med Devices (Auckl). 2026 May 29;19:595863. doi: 10.2147/MDER.S595863. eCollection 2026. PubMed 42239929 ↗
  • Goya M, Park SJ, Ando K, Holbrook R, Iskandar R, Jacobsen L, Mozingo JD, Joung B; SPARK Registry Investigators. Safety and efficacy of an intrinsic antitachycardia pacing algorithm in patients from Japan and South Korea: results from a cardiac device registry in the Asia Pacific region. J Med Econ. 2025 Dec;28(1):1307-1318. doi: 10.1080/13696998.2025.2543213. Epub 2025 Aug 13. PubMed 40758483 ↗
  • Patel D, Rao A, Friedman PA, Deshmukh AJ, Lande J, Murphy JA, Brown ML, Lexcen DR, Wilkoff BL. New atrial arrhythmia occurrence in single chamber implantable cardioverter defibrillator patients: A real-world investigation. J Cardiovasc Electrophysiol. 2023 Feb;34(2):438-444. doi: 10.1111/jce.15790. Epub 2022 Dec 30. PubMed 36579406 ↗
  • Qin D, Filippaios A, Murphy J, Berg M, Lampert R, Schloss EJ, Noone M, Mela T. Short- and Long-Term Risk of Lead Dislodgement Events: Real-World Experience From Product Surveillance Registry. Circ Arrhythm Electrophysiol. 2022 Aug;15(8):e011029. doi: 10.1161/CIRCEP.122.011029. Epub 2022 Aug 4. PubMed 35925831 ↗
  • Garg A, Koneru JN, Fagan DH, Stromberg K, Padala SK, El-Chami MF, Roberts PR, Piccini JP, Cheng A, Ellenbogen KA. Morbidity and mortality in patients precluded for transvenous pacemaker implantation: Experience with a leadless pacemaker. Heart Rhythm. 2020 Dec;17(12):2056-2063. doi: 10.1016/j.hrthm.2020.07.035. Epub 2020 Aug 4. PubMed 32763431 ↗
  • Singh JP, Cha YM, Lunati M, Chung ES, Li S, Smeets P, O'Donnell D. Real-world behavior of CRT pacing using the AdaptivCRT algorithm on patient outcomes: Effect on mortality and atrial fibrillation incidence. J Cardiovasc Electrophysiol. 2020 Apr;31(4):825-833. doi: 10.1111/jce.14376. Epub 2020 Feb 28. PubMed 32009263 ↗
  • Stearns LM, Abd-Elsayed A, Perruchoud C, Spencer R, Hammond K, Stromberg K, Weaver T. Intrathecal Drug Delivery Systems for Cancer Pain: An Analysis of a Prospective, Multicenter Product Surveillance Registry. Anesth Analg. 2020 Feb;130(2):289-297. doi: 10.1213/ANE.0000000000004425. PubMed 31567325 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Sites
5 sites added, 4 sites removed
Show 5 added (2 United States, 1 China, 1 India, 1 Italy)
  • Temecula · Temecula, United States
  • Sewickley · Sewickley, United States
  • Hefei · Hefei, China
  • Gūrgaon · Gūrgaon, India
  • Bergamo · Bergamo, Italy
Show 4 removed
  • Freiburg im Breisgau · Freiburg im Breisgau, Germany
  • Gurgaon · Gurgaon, India
  • Skövde · Skövde, Sweden
  • Leeds · Leeds, United Kingdom
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    5 sites added, 4 sites removed
    Show 5 added (2 United States, 1 China, 1 India, 1 Italy)
    • Temecula · Temecula, United States
    • Sewickley · Sewickley, United States
    • Hefei · Hefei, China
    • Gūrgaon · Gūrgaon, India
    • Bergamo · Bergamo, Italy
    Show 4 removed
    • Freiburg im Breisgau · Freiburg im Breisgau, Germany
    • Gurgaon · Gurgaon, India
    • Skövde · Skövde, Sweden
    • Leeds · Leeds, United Kingdom

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT01524276
Lead sponsor
Medtronic
Responsible party
Sponsor
First posted
Feb 1, 2012
Start date
Jan 2012
Primary completion
Jan 2040 (estimated)
Completion
Jan 2040 (estimated)
Last update
Oct 20, 2026

Study contacts

Medtronic Product Surveillance Registry
Contact
rs.productsurveillanceregistry@medtronic.com

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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