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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 : December 21, 2022
Sponsor:
Information provided by (Responsible Party):
Medtronic

Study Description
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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 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

Study Design
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Study Type : Observational
Estimated Enrollment : 100000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Medtronic Product Surveillance Registry
Study Start Date : January 2012
Estimated Primary Completion Date : January 2030
Estimated Study Completion Date : January 2030
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Safety and Effectiveness of Market Released products [ Time Frame: Every 6-12 months (Therapy-dependent) ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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
Contacts and Locations
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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
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Contact: Medtronic Product Surveillance Registry rs.productsurveillanceregistry@medtronic.com

Locations
Show Show 395 study locations
Sponsors and Collaborators
Medtronic
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic
ClinicalTrials.gov Identifier: NCT01524276    
Other Study ID Numbers: PSR
First Posted: February 1, 2012    Key Record Dates
Last Update Posted: December 21, 2022
Last Verified: December 2022
Additional relevant MeSH terms:
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Digestive System Diseases
Intracranial Aneurysm
Nervous System Diseases
Renal Insufficiency
Coronary Artery Disease
Cardiovascular Diseases
Arrhythmias, Cardiac
Disease
Pathologic Processes
Coronary Disease
Myocardial Ischemia
 Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aneurysm
Kidney Diseases
Urologic Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases