Alterra Adaptive Clinical Trial

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The Alterra study is for patients in need of pulmonary valve replacement. The Alterra Adaptive Prestent is a transcatheter stent designed for patients in need of a pulmonary valve replacement who do not want to have to undergo surgery, but have a pulmonary artery poorly suited for current approved transcatheter valves. Surgical placement of a new valve is the most common treatment for a nonworking pulmonary valve, however, there are many risks associated with open heart surgery and it is followed by months of recovery. We are conducting this study to see whether there is a less invasive approach by placing and Alterra Adaptive Prestent to make the pulmonary artery appropriate for transcatheter valve replacement. The Alterra Adaptive Prestent has not been approved by the FDA yet for commercial use and is only available by participating in the study. Please contact Dr. Matthew Gillespie if you or your patient may be interested in participating in the trial of this device.

Who Do I Contact?

If you are interested in participating in the study or want to learn more please contact our study team at martinoo [at] chop.edu or 215-590-1790.

Eligibility & Criteria

IRB #:
17-014163
Official Title:
Multicenter Trial of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 Interventional THV with the Alterra Adaptive Prestent
Eligible Age Range:
2 - 99 Years
Gender:
All
Study Categories:

Leader

Matthew J. Gillespie, MD