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Product Surveillance Registry (PSR)

This study is currently recruiting participants.
Verified September 2017 by Medtronic
Sponsor:
ClinicalTrials.gov Identifier:
NCT01524276
First Posted: February 1, 2012
Last Update Posted: September 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic
January 30, 2012
February 1, 2012
September 15, 2017
January 2012
January 2024   (Final data collection date for primary outcome measure)
Safety and Effectiveness of Market Released products [ Time Frame: Every 6-12 months (Therapy-dependent) ]
Not Provided
Complete list of historical versions of study NCT01524276 on ClinicalTrials.gov Archive Site
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Product Surveillance Registry
Medtronic Product Surveillance Registry
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Subjects implanted with Medtronic qualifying therapy product.
  • Cardiac Rhythm Disorders
  • Urological and Digestive Disorders
  • Neurological Disorders
  • Cardiovascular Disorders
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
55000
January 2024
January 2024   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact: Medtronic Product Surveillance Registry rs.productsurveillanceregistry@medtronic.com
Argentina,   Belgium,   Canada,   Colombia,   Czechia,   Denmark,   France,   Germany,   Greece,   Hungary,   Iceland,   Israel,   Italy,   Kuwait,   Mexico,   Netherlands,   New Zealand,   Norway,   Poland,   Portugal,   Puerto Rico,   Saudi Arabia,   Serbia,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
 
 
NCT01524276
PSR
No
Not Provided
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Medtronic
Medtronic
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Not Provided
Medtronic
September 2017