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

This study has been terminated.
(By recommendation from the Data and safety monitoring board)
Sponsor:
Collaborators:
Odense University Hospital
Danish Heart Foundation
Information provided by (Responsible Party):
Leif Thuesen, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT00986193
First received: September 25, 2009
Last updated: September 28, 2011
Last verified: September 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Aortic Valve Stenosis
 Procedure: Transapical Aortic Valve Implantation
Procedure: Conventional Aortic Valve Surgery
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Comparison of Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Skejby Hospital:

Primary Outcome Measures:
  • Death, CVI and/or renal failure requiring any dialysis [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Echocardiographic results, valve performance [ Time Frame: 1 month with subseguent followup ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: December 2008
Estimated Study Completion Date: April 2016
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00986193

Locations
Denmark
Aarhus University Hospital, Skejby
Aarhus N, Region Midtjylland, Denmark, 8200
Sponsors and Collaborators
Skejby Hospital
Odense University Hospital
Danish Heart Foundation
Investigators
Principal Investigator: Leif Thuesen, MD Skejby Hospital, Aarhus, Denmark
  More Information

No publications provided

Responsible Party: Leif Thuesen, Director Cardiac Cath.Lab.,, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00986193     History of Changes
Other Study ID Numbers: Skejby 2008-1
Study First Received: September 25, 2009
Last Updated: September 28, 2011
Health Authority: Denmark: National Board of Health

Keywords provided by Skejby Hospital:
Aortic Valve Stenosis
Stent Valve
Biological Aortic Valve Prosthesis

Additional relevant MeSH terms:
Aortic Valve Stenosis
Constriction, Pathologic
Heart Valve Diseases
Heart Diseases
 Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 19, 2013