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Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve (TRITON)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Edwards Lifesciences Identifier:
First received: August 5, 2011
Last updated: November 19, 2015
Last verified: November 2015
The purpose of this clinical investigation is to confirm that the safety and performance of the EDWARDS INTUITY Valve System.

Condition Intervention
Aortic Valve Stenosis With Insufficiency
Aortic Valve Stenosis
Device: Aortic Valve Replacement with EDWARDS INTUITY Valve System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve

Resource links provided by NLM:

Further study details as provided by Edwards Lifesciences:

Primary Outcome Measures:
  • Composite of Heart valve objective performance criteria (OPC) [ Time Frame: up to 5 years ]

    Safety Endpoints:

    • Study valve-related mortality Thromboembolic Events
    • Study Valve thrombosis
    • Major Bleeding Events
    • Study valve paravalvular leakage
    • Study valve-related endocarditis

    Performance Endpoints:

    • Device Technical Success
    • Procedure success
    • New York Heart Association (NYHA)
    • Hemodynamic performance

    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.

Secondary Outcome Measures:
  • Composite of Hemodynamic Performance [ Time Frame: At each follow-up interval (up to 5 years) ]
    All cause mortality, Index valve structural valve deterioration, Hemolysis, Index valve-related reoperation, Index valve Explantation, all adverse events

Estimated Enrollment: 295
Study Start Date: January 2010
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Study Valve
Subjects act as own control
Device: Aortic Valve Replacement with EDWARDS INTUITY Valve System
Aortic Valve bioprosthesis

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


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 echocardiograpic 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01445171

AKH Vienna-Allgemeines Krankenhaus der Stadt Wien; University Vienna
Vienna, Austria, 1090
Kerchoff Klinik-Bad Nauheim
Bad Nauheim, Germany, 61231
MHH-Medizinische Hoschschule Hannover
Hannover, Germany, 30625
Herzzentrum Uniklink Koln-Klinik und Poliklinik fur Herz und Thoraxzchirurgie
Koeln, Germany, 50937
University Leipzig: Herzzentrum Leipzig Gmbh
Leipzig, Germany, 04289
Klinikum der Universitat Muchen-Grosshadern; Clinic at the University of Munich
Munich, Germany, 81377
Sponsors and Collaborators
Edwards Lifesciences
Study Director: Prof Axel Haverich MHH Hannover
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Edwards Lifesciences Identifier: NCT01445171     History of Changes
Other Study ID Numbers: 2009-01
Study First Received: August 5, 2011
Last Updated: November 19, 2015

Keywords provided by Edwards Lifesciences:
Aortic Valve Replacement

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Heart Defects, Congenital
Heart Valve Diseases
Pathological Conditions, Anatomical
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Cardiovascular Abnormalities
Congenital Abnormalities processed this record on May 25, 2017