Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve

Brief Title

Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve

Official Title

Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve

Brief Summary

      The purpose of this clinical investigation is to confirm that the safety and performance of
      the EDWARDS INTUITY Valve System.

Detailed Description

      This is a two-phase, non-randomized, prospective, single arm, multi-center clinical
      investigation. Each subject in Phase 1 and Phase 2 is consented for a period of 5 years. All
      subjects will be assessed for clinical follow-up at the following intervals: Discharge, 1
      month, 3 months, 1 year and annually thereafter until 5 years of follow-up is achieved per
      subject.

Study Type

Interventional

Primary Outcome

Percent of Early Adverse Events

Condition

Aortic Valve Stenosis With Insufficiency

Intervention

Aortic Valve Replacement with EDWARDS INTUITY Valve System

Study Arms / Comparison Groups

 Study Valve

Description:  Subjects act as own control

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

Device

Estimated Enrollment

Start Date

January 2010

Completion Date

December 2017

Primary Completion Date

December 2017

Eligibility Criteria

        Criteria:

        Inclusion Criteria:

          -  18 years or older

          -  Aortic stenosis or stenosis-insufficiency of aortic valve requiring a planned
             replacement as indicated in the preoperative evaluation;

          -  Scheduled to undergo planned aortic valve replacement with or without concomitant
             coronary bypass surgery, MAZE procedure, septal myectomy, pacemaker/ICD implant and or
             atrial appendage occlusion/removal.

          -  Signed and dated the informed consent form prior to investigation procedures;

          -  Geographically stable and agrees to attend Follow up assessments at the hospital of
             surgical services for a maximum of 5 years.

        Exclusion Criteria:

          -  Pure aortic insufficiency

          -  Requires emergency surgery

          -  Aneurysm of the aortic root and/or ascending aorta requiring surgical intervention

          -  Left ventricular ejection fraction of ≤ 25%

          -  Active endocarditis within 3 months prior to the scheduled aortic valve replacement
             surgery

          -  Concomitant valve (mitral, tricuspid, or pulmonic) disease requiring repair with an
             annuloplasty ring or replacement with prosthesis

          -  Prior mitral, tricuspid or pulmonic valve surgery, which included implantation of a
             bioprosthetic valve, mechanical valve, or annuloplasty ring.

          -  Myocardial infarction (MI) within 1 month prior to the scheduled aortic valve
             replacement surgery

          -  Previously implanted with EDWARDS INTUITY Aortic valve; alcohol or drug abuser

          -  Disease limiting life expectancy to less than 12 months

          -  Pregnant or lactating

          -  Currently participating in another drug or device clinical investigation;

          -  Documented blood diatheses

          -  Requires non-cardiac procedures such as carotid procedures or mediastinal tumor
             removal

          -  Had a stroke or transient ischemic attack (TIA) within 6-months prior to scheduled
             aortic valve replacement surgery

          -  Study site pre-operative echocardiographic assessment shows evidence of an
             intracardiac mass, thrombus, or vegetation

          -  Hemodynamic or respiratory instability requiring inotropic support, mechanical
             circulatory support, or mechanical ventilation within 30 days of procedure

          -  Documented renal insufficiency as determined by Serum creatinine ≥ 200 µmol/L (2.27
             mg/dL) at screening or end-stage renal disease requiring chronic dialysis

          -  Documented hyperparathyroidism

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Prof Axel Haverich, ,

Location Countries

Austria

Location Countries

Austria

Administrative Informations

NCT ID

NCT01445171

Organization ID

2009-01

Responsible Party

Sponsor

Study Sponsor

Edwards Lifesciences

Study Sponsor

Prof Axel Haverich, Study Director, MHH Hannover

Verification Date

February 2020