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Product Surveillance Registry (PSR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Medtronic
Sponsor:
Information provided by (Responsible Party):
Medtronic
ClinicalTrials.gov Identifier:
NCT01524276
First received: January 30, 2012
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

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
Cardiac Rhythm Disorders
Urological and Digestive Disorders
Neurological Disorders
Cardiovascular Disorders

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Medtronic Product Surveillance Registry

Resource links provided by NLM:


Further study details as provided by Medtronic:

Primary Outcome Measures:
  • Safety and Effectiveness of Market Released products [ Time Frame: Every 6-12 months (Therapy-dependent) ] [ Designated as safety issue: No ]

Estimated Enrollment: 15000
Study Start Date: January 2012
Estimated Primary Completion Date: January 2024 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
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 30 days of 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01524276

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

  Show 145 Study Locations
Sponsors and Collaborators
Medtronic
  More Information

No publications provided

Responsible Party: Medtronic
ClinicalTrials.gov Identifier: NCT01524276     History of Changes
Other Study ID Numbers: PSR
Study First Received: January 30, 2012
Last Updated: October 6, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Ethics Review Committee
France: Conseil National de l ordre des Médecins
Germany: Federal Institute for Drugs and Medical Devices
Serbia: Ethics Committee
Switzerland: Ethics Committee
Sweden: Regional Ethical Review Board
Italy: Ethics Committee
Netherlands: Independent Ethics Committee
United Kingdom: Research Ethics Committee
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Belgium: Ethics Committee

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

ClinicalTrials.gov processed this record on November 25, 2014