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

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Effect of vItamin K2 on Calciummetabolism on 18F-NaF PET/MRI Endothelial Progenitors in Aortic Stenosis: Association With Aortic Stenosis Progression and Severity Outcomes of Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis Evaluation of BAV in Different Hemodynamic Entities of Severe AS Intravenous Iron Supplement for Iron Deficiency in Patients With Severe Aortic Stenosis The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic Severe Aortic Stenosis Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement Outcomes of Transcatheter Aortic Valve Implantation in Management of Severe Symptomatic Aortic Stenosis Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population Rehabilitation in Aortic Stenosis Patients Aortic Stenosis Evaluated Via Modern Ballistocardiography and Seismocardiography Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve The Plasma Serotonin and Aortic Stenosis: a Pilot Study. 18F-NaF Uptake and Aortic Stenosis Progression Cardiovascular Rehabilitation in Patients With Severe Aortic Stenosis Submitted to Valvar Correction Aortic Stenosis and PhosphodiEsterase Type 5 iNhibition (ASPEN): A Pilot Study Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis Fetal Intervention for Aortic Stenosis and Evolving Hypoplastic Left Heart Syndrome The PARTNER 3 – Trial – The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis Ventricular Remodeling In Patients With Aortic Stenosis Assessed 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PCSK9 Inhibitors in the Progression of Aortic Stenosis Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis Randomized Study to Evaluate the Efficacy of Fluvastatin on Inflammatory Markers in Patients With Aortic Stenosis. 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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

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.

Study Type

Interventional

Primary Outcome

Death, CVI and/or renal failure requiring any dialysis

Secondary Outcome

 Echocardiographic results, valve performance

Condition

Aortic Valve Stenosis

Intervention

Transapical Aortic Valve Implantation

Study Arms / Comparison Groups

 Conventional Aortic Valve Surgery
Description:  Insertion of a biological valve

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

72

Start Date

December 2008

Completion Date

April 2016

Primary Completion Date

April 2011

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

Gender

All

Ages

75 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Evald H Christiansen, MD, ,

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations

NCT ID

NCT00986193

Organization ID

Skejby 2008-1

Responsible Party

Principal Investigator

Study Sponsor

Aarhus University Hospital Skejby

Collaborators

 Odense University Hospital

Study Sponsor

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

Verification Date

May 2017