Clinical trial NCT00986193: Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis
Official title: Randomized Comparison of Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aortic Valve Stenosis
Keywords: Aortic Valve Stenosis
Stent Valve
Biological Aortic Valve Prosthesis
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: Danish Heart Foundation
First posted: 2009-09-29
Enrollment: 72
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Death, CVI and/or renal failure requiring any dialysis
timeFrame: 1 month
Secondary outcomes:
measure: Echocardiographic results, valve performance
timeFrame: 1 month with subseguent followup
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital, Skejby
state: Region Midtjylland
Study officials:
affiliation: Skejby Hospital, Aarhus, Denmark
name: Evald H Christiansen, MD
role: PRINCIPAL_INVESTIGATOR
References: