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New Trials for Heart Valve Replacement Underway

Heart teams look to trials to improve on current successes of transcatheter procedures

Heart in hands light background (blog)Aortic valve replacement is a life-saving option for many patients when medication and repair don’t solve the problem of stiffened or narrowed aortic valves that interfere with normal blood supply to the body.

Two studies underway at the University of Michigan Frankel Cardiovascular Center are examining techniques that allow physicians to recapture and reposition an artificial valve during transcatheter aortic valve replacement (TAVR).

The trials may build on the success of the minimally invasive procedure that’s made aortic valve replacement possible for those considered too old or too frail for open heart surgery.

REPRISE III

This month, the University of Michigan became the first heart center in Michigan to enroll a patient in the REPRISE III study to test the performance of Boston Scientific’s Lotus Aortic Valve System.

The safety of the Lotus system, which can be repositioned before being deployed to take over for the diseased aortic valve, will be compared against the FDA-approved CoreValve® system. Lotus also includes a feature designed to reduce the frequency of paravalvular regurgitation (leaking). Still an investigational device, if this technology holds up as well as in two previous clinical trials, the study may bring new technology to physicians and patients in the U.S.

Researchers across the country will follow the progress of more than 1,000 patients in the study. Among other issues, they will collect and analyze data involving:

  • Effectiveness of valve
  • Need for repeat surgery
  • Stroke rates
  • Leaks, bleeding or other complications
  • Overall survival

CoreValve® Evolut R Clinical Study

Medtronic is testing a TAVR system that can be recaptured and repositioned – the CoreValve® Evolut R. The system is designed, according to national investigators, to provide physicians a back-up plan in case the valve isn’t positioned correctly at first. CoreValve® Evolut R has a smaller delivery system than its first generation devices.

The University of Michigan Cardiovascular is among the 25 CoreValve® Evolut R study sites that will follow 250 patients and look at:

  • Effectiveness of the valve
  • Overall survival
  • Valve leakage
  • Side effects such as stroke

Clinical trials have revealed the effectiveness of TAVR as an alternative to open heart surgery, and through additional study, U-M physicians aim to improve outcomes for those with severe aortic stenosis.

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Frankel-informal-vertical-sigThe U-M is a leader in the quest for new options for structural heart repairs. Heart teams at the University of Michigan Cardiovascular Center have performed more than 400 TAVR procedures, making the hospital tops in the nation for investigational and real-world TAVR experience.