NCT01524276: PSR

Medtronic Product Surveillance Registry

Recruiting now Last updated 18 May 2026

What this trial tests

trial in Cardiac Rhythm Disorders in 100,000 participants. Currently enrolling.

Timeline

1 January 2012

Primary endpoint
1 January 2040

1 January 2040

Quick facts

Lead sponsor	Medtronic
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	100,000
Start date	1 January 2012
Primary completion	1 January 2040
Estimated completion	1 January 2040
Sites	393 locations across United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China

Conditions studied

• Cardiac Rhythm Disorders — all drugs for Cardiac Rhythm Disorders →
• Urological Disorders — all drugs for Urological Disorders →
• Neurological Disorders — all drugs for Neurological Disorders →
• Cardiovascular Disorders — all drugs for Cardiovascular Disorders →

Sponsor

Medtronic — full company profile →

Who can join

Eligibility, any sex, with Cardiac Rhythm Disorders or Urological Disorders. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Safety and Effectiveness of Market Released products
  Time frame: Every 6-12 months (Therapy-dependent)

Sponsor's own 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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Intrathecal Drug Delivery Systems for Cancer Pain: An Analysis of a Prospective, Multicenter Product Surveillance Registry.
   Stearns LM, Abd-Elsayed A, Perruchoud C, Spencer R, et al · · 2020 · cited 54× · PMID 31567325 · DOI 10.1213/ane.0000000000004425
2. Real-world behavior of CRT pacing using the AdaptivCRT algorithm on patient outcomes: Effect on mortality and atrial fibrillation incidence.
   Singh JP, Cha YM, Lunati M, Chung ES, et al · · 2020 · cited 31× · PMID 32009263 · DOI 10.1111/jce.14376
3. Morbidity and mortality in patients precluded for transvenous pacemaker implantation: Experience with a leadless pacemaker.
   Garg A, Koneru JN, Fagan DH, Stromberg K, et al · · 2020 · cited 21× · PMID 32763431 · DOI 10.1016/j.hrthm.2020.07.035
4. Intrathecal Baclofen for Severe Spasticity: Longitudinal Data From the Product Surveillance Registry.
   Schiess MC, Eldabe S, Konrad P, Molus L, et al · · 2020 · cited 18× · PMID 31989725 · DOI 10.1111/ner.13097
5. Short- and Long-Term Risk of Lead Dislodgement Events: Real-World Experience From Product Surveillance Registry.
   Qin D, Filippaios A, Murphy J, Berg M, et al · · 2022 · cited 12× · PMID 35925831 · DOI 10.1161/circep.122.011029
6. Targeted Drug Delivery for Chronic Nonmalignant Pain: Longitudinal Data From the Product Surveillance Registry.
   Schultz DM, Abd-Elsayed A, Calodney A, Stromberg K, et al · · 2021 · cited 7× · PMID 33449428 · DOI 10.1111/ner.13353
7. Applying computable phenotypes within a common data model to identify heart failure patients for an implantable cardiac device registry.
   Graham J, Iverson A, Monteiro J, Weiner K, et al · · 2022 · cited 4× · PMID 35242997 · DOI 10.1016/j.ijcha.2022.100974
8. 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.
   Goya M, Park SJ, Ando K, Holbrook R, et al · · 2025 · cited 1× · PMID 40758483 · DOI 10.1080/13696998.2025.2543213