EASE study

• Research type

  Research Study

• Full title

  Enable® Aortic Sutureless bioprosthesis Evaluation: a post-market release study (EASE study).

• IRAS ID

  139365

• Contact name

  Andrew Goodwin

• Contact email

  andrew.goodwin1@nhs.net

• Sponsor organisation

  Medtronic Bakken Research Center BV

• Clinicaltrials.gov Identifier

  NCT01720342

• Research summary

  This is a Post-Market Release study to collect data on patients who will be implanted with the Medtronic Enable® heart valve, a standard procedure that will not be altered for study purposes. Safety and clinical performance of the Medtronic Enable® heart valve will be expected to be followed for 5 years in post market real world patients. Up to a maximum of 800 patients will be enrolled in a maximum of 40 European sites. The Medtronic Enable® aortic bioprosthesis (Model 6000) is commercially released, CE-mark since December 2009, and used within its intended use; and available in Europe.
  The Medtronic Enable® heart valve consists of a metal self-expanding framework (Nitinol stent) coated with polyester material. Because the framework is self-expanding, this valve is designed to remain in the position where the doctor places it. In most cases, the Medtronic Enable® heart valve can be implanted in a very short time so that the patient spends less time on the heart-lung machine.

• REC name

  Yorkshire & The Humber - Bradford Leeds Research Ethics Committee

• REC reference

  13/YH/0416

• Date of REC Opinion

  13 Mar 2014

• REC opinion

  Further Information Favourable Opinion