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Product Surveillance Registry (PSR)

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.
ClinicalTrials.gov Identifier: NCT01524276
Recruitment Status : Recruiting
First Posted : February 1, 2012
Last Update Posted : September 15, 2017
Sponsor:
Information provided by (Responsible Party):
Medtronic

Brief 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.

Condition or disease
Cardiac Rhythm Disorders Urological and Digestive Disorders Neurological Disorders Cardiovascular Disorders

Study Type : Observational
Estimated Enrollment : 55000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Medtronic Product Surveillance Registry
Study Start Date : January 2012
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024



Primary Outcome Measures :
  1. Safety and Effectiveness of Market Released products [ Time Frame: Every 6-12 months (Therapy-dependent) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects implanted with Medtronic qualifying therapy product.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01524276


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

  Show 254 Study Locations
Sponsors and Collaborators
Medtronic

Responsible Party: Medtronic
ClinicalTrials.gov Identifier: NCT01524276     History of Changes
Other Study ID Numbers: PSR
First Posted: February 1, 2012    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Disease
Nervous System Diseases
Digestive System Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Heart Diseases