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Product Surveillance Registry-APV

Overview

Acerca de este estudio

The purpose of this study is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products for their intended use, to obtain real-world performance and safety information from a global network of hospitals, clinics, and clinicians intended to represent the range of clinical environments in which Medtronic products are used to support post-market surveillance activities and post-approval studies that are initiated by Medtronic, regulated by local governments, or are conducted to fulfill government and/ or regulatory authority requests, to obtain clinical evidence to guide the development and improvement of medical devices, therapies, device guidelines, and patient services/solutions and to provide clinical data to support health economics and clinical outcomes research.

Elegibilidad para participar

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Patient or legally authorized representative (LAR) provides 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 is consented within the enrollment window of the therapy received, as applicable.

Exclusion Criteria:

  • Patient who is, or is expected to be, inaccessible for follow-up.
  • Patient is excluded by local law.
  • Patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the PSR results (i.e., no required intervention that could affect interpretation of all-around product safety and/or effectiveness).

 

 

Ubicaciones participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Ubicación de Mayo Clinic Estado Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Sanjay Misra, M.D.

Inscripción cerrada

Contact information:

Jennifer Murphy

(507) 538-0540

Murphy.Jennifer@mayo.edu

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20523998

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