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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2011 by Edwards Lifesciences
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT01445171
First received: August 5, 2011
Last updated: September 30, 2011
Last verified: September 2011
  Purpose

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: Endpoint Classification: Safety Study
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 ] [ Designated as safety issue: Yes ]

    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) ] [ Designated as safety issue: Yes ]
    All cause mortality, Index valve structural valve deterioration, Hemolysis, Index valve-related reoperation, Index valve Explantation, all adverse events


Estimated Enrollment: 350
Study Start Date: January 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: January 2015 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  • 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%; Congenital bicuspid aortic valve or unicuspid valve;
  • 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;
  • 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;
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01445171

Contacts
Contact: Carol Renner, BSN 949-250-2389 carol_renner@edwards.com

Locations
Austria
AKH Vienna-Allgemeines Krankenhaus der Stadt Wien; University Vienna Recruiting
Vienna, Austria, 1090
Contact: Dominik Wiedemann    43 (66) 44 02 11 45    Dominik.wiedemann@meduniwien.ac.at   
Principal Investigator: Prof. Dr. Gunther Laufer, MD         
Germany
Kerchoff Klinik-Bad Nauheim Recruiting
Bad Nauheim, Germany, 61231
Contact: Johannes Blumenstein    +49(0)603 299 62502    j.Blumenstein@kerckhoff-klinik.de   
Principal Investigator: Professor Walther, MD         
MHH-Medizinische Hoschschule Hannover Recruiting
Hannover, Germany, 30625
Contact: Stefanie Zimmerman    49 511 532 6581    Zimmermann.Stefanie@mh-hannover.de   
Principal Investigator: Axel Haverich, MD         
Herzzentrum Uniklink Koln-Klinik und Poliklinik fur Herz und Thoraxzchirurgie Recruiting
Koeln, Germany, 50937
Contact: Mareike Schink    49(221)478 325 08    Mareike.schink@uk-koeln.de   
Principal Investigator: Georg Langebartels, Dr. Med.         
University Leipzig: Herzzentrum Leipzig Gmbh Recruiting
Leipzig, Germany, 04289
Contact: Marika Viehweg    49 341 865 25 1074    Marika.viehweg@herzzentrum-leipzig.de   
Principal Investigator: Professor Borger, MD         
Klinikum der Universitat Muchen-Grosshadern; Clinic at the University of Munich Recruiting
Munich, Germany, 81377
Contact: Rene Schramm    49(89)7095-3464    Rene.schramm@med.uni-muenchen.de   
Principal Investigator: Christop Schmitz, MD         
Switzerland
Bern University Hospital Recruiting
Bern, Switzerland, 310
Contact: Dorothee Keller    41 (31) 6322375    Dorothee.Keller@insel.ch   
Principal Investigator: Thierry P Carrel, MD         
Sponsors and Collaborators
Edwards Lifesciences
Investigators
Study Director: Carol Renner, BSN Edwards Lifesciences
  More Information

No publications provided by Edwards Lifesciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT01445171     History of Changes
Other Study ID Numbers: 2009-01
Study First Received: August 5, 2011
Last Updated: September 30, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Federal Office for Safety in Health Care
Switzerland: Swissmedic

Keywords provided by Edwards Lifesciences:
Aortic Valve Replacement

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

ClinicalTrials.gov processed this record on August 20, 2014