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

May 31, 2017 updated by: Evald Hoej Christiansen, Aarhus University Hospital Skejby

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Midtjylland
      • Aarhus N, Region Midtjylland, Denmark, 8200
        • Aarhus University Hospital, Skejby

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional Aortic Valve Surgery
Insertion of a biological valve
Procedure: Conventional Aortic Valve Surgery
Operation using heart-lung machine, with insertion of a biological artificial heart valve
Experimental: Transapical Aortic Valve Implantation
Transapical implantation of an Edwards SAPIENtm valve
Procedure: Transapical Aortic Valve Implantation
Insertion of a stent valve using catheter-based technique through a mini thoracotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Death, CVI and/or renal failure requiring any dialysis
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Echocardiographic results, valve performance
Time Frame: 1 month with subseguent followup
1 month with subseguent followup

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital Skejby

Collaborators

Odense University Hospital
Danish Heart Foundation

Investigators

  • Principal Investigator: Evald H Christiansen, MD, Skejby Hospital, Aarhus, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

September 25, 2009

First Submitted That Met QC Criteria

September 28, 2009

First Posted (Estimate)

September 29, 2009

Study Record Updates

Last Update Posted (Actual)

June 1, 2017

Last Update Submitted That Met QC Criteria

May 31, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Skejby 2008-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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