search
Back to results

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

Primary Purpose

Aortic Valve Stenosis

Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Transapical Aortic Valve Implantation
Conventional Aortic Valve Surgery
Sponsored by
Aarhus University Hospital Skejby
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Aortic Valve Stenosis, Stent Valve, Biological Aortic Valve Prosthesis

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Aarhus University Hospital, Skejby

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Aortic Valve Surgery

Transapical Aortic Valve Implantation

Arm Description

Insertion of a biological valve

Transapical implantation of an Edwards SAPIENtm valve

Outcomes

Primary Outcome Measures

Death, CVI and/or renal failure requiring any dialysis

Secondary Outcome Measures

Echocardiographic results, valve performance

Full Information

First Posted
September 25, 2009
Last Updated
May 31, 2017
Sponsor
Aarhus University Hospital Skejby
Collaborators
Odense University Hospital, Danish Heart Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT00986193
Brief Title
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

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
By recommendation from the Data and safety monitoring board
Study Start Date
December 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital Skejby
Collaborators
Odense University Hospital, Danish Heart Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis
Keywords
Aortic Valve Stenosis, Stent Valve, Biological Aortic Valve Prosthesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Aortic Valve Surgery
Arm Type
Active Comparator
Arm Description
Insertion of a biological valve
Arm Title
Transapical Aortic Valve Implantation
Arm Type
Experimental
Arm Description
Transapical implantation of an Edwards SAPIENtm valve
Intervention Type
Procedure
Intervention Name(s)
Transapical Aortic Valve Implantation
Intervention Description
Insertion of a stent valve using catheter-based technique through a mini thoracotomy
Intervention Type
Procedure
Intervention Name(s)
Conventional Aortic Valve Surgery
Intervention Description
Operation using heart-lung machine, with insertion of a biological artificial heart valve
Primary Outcome Measure Information:
Title
Death, CVI and/or renal failure requiring any dialysis
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Echocardiographic results, valve performance
Time Frame
1 month with subseguent followup

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evald H Christiansen, MD
Organizational Affiliation
Skejby Hospital, Aarhus, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital, Skejby
City
Aarhus N
State/Province
Region Midtjylland
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs