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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 : March 1, 2023
Sponsor:
Information provided by (Responsible Party):
Medtronic

Tracking Information
First Submitted Date January 30, 2012
First Posted Date February 1, 2012
Last Update Posted Date March 1, 2023
Study Start Date January 2012
Estimated Primary Completion Date January 2030   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 6, 2014)		 Safety and Effectiveness of Market Released products [ Time Frame: Every 6-12 months (Therapy-dependent) ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Product Surveillance Registry
Official Title Medtronic Product Surveillance Registry
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects implanted with Medtronic qualifying therapy product.
Condition
  • 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
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 2, 2018)		 100000
Original Estimated Enrollment
 (submitted: January 30, 2012)		 3300
Estimated Study Completion Date January 2030
Estimated Primary Completion Date January 2030   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Medtronic Product Surveillance Registry rs.productsurveillanceregistry@medtronic.com
Listed Location Countries Argentina,   Australia,   Belgium,   Brazil,   Canada,   Chile,   China,   Colombia,   Czechia,   Denmark,   Finland,   France,   Germany,   Greece,   Hong Kong,   Hungary,   Iceland,   India,   Israel,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   Norway,   Poland,   Portugal,   Puerto Rico,   Russian Federation,   Saudi Arabia,   Serbia,   Slovakia,   Slovenia,   South Africa,   Spain,   Sweden,   Switzerland,   United Arab Emirates,   United Kingdom,   United States
Removed Location Countries Austria,   Jordan,   Kazakhstan,   Kuwait,   New Zealand,   Turkey
 
Administrative Information
NCT Number NCT01524276
Other Study ID Numbers PSR
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Medtronic
Original Responsible Party Same as current
Current Study Sponsor Medtronic
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Medtronic
Verification Date February 2023