Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 1:16 AM
NCT ID:
NCT00986193
Brief Summary:
This study is a randomised comparison of apical stent valve treatment versus conventional valve surgery in patients with severe aortic valve stenosis.
Detailed Description:
The purpose of the study is to compare the new established apical stent valve treatment with conventional surgical intervention using biological valve prostheses in patients with severe aortic valve stenosis.
The Edwards-SAPIENTM Transcatheter Heart Valve (Edwards Lifesciences, Irvine, CA) will be used in the stent valve group. The Carpentier-Edwards-Perimount Heart Valve (Edwards Lifesciences, Irvine, CA) will be recommended for the conventional surgery group.(Edwards Lifesciences, Irvine, CA).
Heart centres in the Nordic region with experience (\>10 cases) in apical stent valve treatment and in conventional surgical treatment of high risk patients with aortic valve stenosis. The study will be initiated at Aarhus University Hospital, Skejby, Denmark.
Study hypothesis:
As compared to conventional aortic valve substitution in patients aged \>75 years, apical stent valve treatment reduces the rates of death, cerebrovascular insult (CVI) and need of dialysis for renal failure 1 month after the treatment.
Primary clinical end-point:
Combined end-point consisting of death, CVI and/or renal failure with need for haemodialysis, 1 month after index treatment.
Study:
NCT00986193
Study Brief:
Protocol Section:
NCT00986193