NCT00986193

Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis

Randomized Comparison of Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Aarhus University Hospital Skejby · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
PROCEDURE	Transapical Aortic Valve Implantation	Insertion of a stent valve using catheter-based technique through a mini thoracotomy
PROCEDURE	Conventional Aortic Valve Surgery	Operation using heart-lung machine, with insertion of a biological artificial heart valve

Timeline

• Start date: 2008-12-01
• Primary completion: 2011-04-01
• Completion: 2016-04-01
• First posted: 2009-09-29
• Last updated: 2017-06-01

Locations

1 site across 1 country: Denmark