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

Aortic Valve Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00986193
• Other study ID #: Skejby 2008-1
• Status: Terminated
• Phase: N/A
• First received: September 25, 2009
• Last updated: May 31, 2017
• Start date: December 2008
• Est. completion date: April 2016

Study information

• Verified date: May 2017
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 72
• Est. completion date: April 2016
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

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

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Skejby	Aarhus N	Region Midtjylland

Sponsors (3)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby	Danish Heart Foundation, Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death, CVI and/or renal failure requiring any dialysis		1 month
Secondary	Echocardiographic results, valve performance		1 month with subseguent followup