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

Not Applicable

Terminated

• Conditions: Aortic Valve Stenosis
• Interventions: Procedure: Transapical Aortic Valve Implantation; Procedure: Conventional Aortic Valve Surgery

• Registration Number: NCT00986193
• Lead Sponsor: Aarhus University Hospital Skejby

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 Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-09-25
• Study First Submitted QC: 2009-09-28
• Study First Posted: 2009-09-29
• Primary Completion: 2011-04
• Study Completion: 2016-04
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-31
• Last Update Posted: 2017-06-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Significant aortic valve stenosis (valve area < 1cm2)
• Age > 75 (years Aarhus University Hospital, Skejby)
• Age > 80 years (other participating centres)
• Operable by conventional surgery AND transapical stent valve implantation
• Expected survival > 1 year following successful treatment
• Accept of participation and in follow-up investigations after adequate information
• Informed consent

Exclusion Criteria

• Coronary artery disease requiring PCI or CABG
• Earlier cardiac surgery
• Myocardial infarction within 24 hours
• Kidney failure requiring any dialysis
• Ongoing infection
• Acute surgery
• Allergy to ASA or Clopidogrel

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transapical Aortic Valve Implantation	Transapical Aortic Valve Implantation	Transapical implantation of an Edwards SAPIENtm valve
Conventional Aortic Valve Surgery	Conventional Aortic Valve Surgery	Insertion of a biological valve

Primary Outcome Measures

Name	Time	Method
Death, CVI and/or renal failure requiring any dialysis	1 month

Secondary Outcome Measures

Name	Time	Method
Echocardiographic results, valve performance	1 month with subseguent followup

Trial Locations

Locations (1)

Aarhus University Hospital, Skejby; 🇩🇰 Aarhus N, Region Midtjylland, Denmark