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Product Surveillance Registry (PSR)

Purpose of Study

The Registry is intended to benefit patients, hospitals, clinicians, regulatory bodies, payers and industry by collecting data to meet the following objectives:

• To identify unique device failure modes, unanticipated adverse events or trends

• To characterize patient outcomes

• To characterize patterns of product use

• To characterize predictors of performance and effectiveness

• To identify signals of emerging performance issues

Trial Status

Enrolling

Eligibility Criteria

•Patient has or is intended to receive or be treated with an eligible Medtronic product.

• Patient within specified enrollment window

• Patient who is, or will be accessible for follow-up

• Participation is not excluded by local law

• Patient is not enrolled in a concurrent drug and/or device study that may confound registry results

Duration of Participation

  • Medtronic stops the registry
  • You no longer have a device followed in the registry
  • You fail to keep your appointments or follow your doctor’s advice
  • Your registry provider no longer participates in the registry
  • If it is in your best interest

Contact Name: Lindsay Risk

Contact Phone: 515-633-3847

Contact Email: lirisk@iowaheart.com