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

Aarhus University Hospital Skejby

Status: Terminated

Conditions: Aortic Valve Stenosis

Treatments: Procedure: Conventional Aortic Valve Surgery; Procedure: Transapical Aortic Valve Implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT00986193

Skejby 2008-1

Details and patient eligibility

About

This study is a randomised comparison of apical stent valve treatment versus conventional valve surgery in patients with severe aortic valve stenosis.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Conventional Aortic Valve Surgery

Active Comparator group

Description:

Insertion of a biological valve

Treatment:

Procedure: Conventional Aortic Valve Surgery

Transapical Aortic Valve Implantation

Experimental group

Description:

Transapical implantation of an Edwards SAPIENtm valve

Treatment:

Procedure: Transapical Aortic Valve Implantation