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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00986193

Enrollment

Registered

2009-09-29

Start date

2008-12-31

Completion date

2016-04-30

Last updated

2017-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis

Keywords

Aortic Valve Stenosis, Stent Valve, Biological Aortic Valve Prosthesis

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.

Interventions

PROCEDURETransapical Aortic Valve Implantation

Insertion of a stent valve using catheter-based technique through a mini thoracotomy

PROCEDUREConventional Aortic Valve Surgery

Operation using heart-lung machine, with insertion of a biological artificial heart valve

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

75 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Death, CVI and/or renal failure requiring any dialysis	1 month

Secondary

Measure	Time frame
Echocardiographic results, valve performance	1 month with subseguent followup

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026