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

August 5, 2011
September 30, 2011
January 2010
January 2015   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01445171 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve
Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve

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

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.

Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Aortic Valve Stenosis With Insufficiency
  • Aortic Valve Stenosis
Device: Aortic Valve Replacement with EDWARDS INTUITY Valve System
Aortic Valve bioprosthesis
Study Valve
Subjects act as own control
Intervention: Device: Aortic Valve Replacement with EDWARDS INTUITY Valve System
Kocher AA, Laufer G, Haverich A, Shrestha M, Walther T, Misfeld M, Kempfert J, Gillam L, Schmitz C, Wahlers TC, Wippermann J, Mohr FW, Roth M, Skwara A, Rahmanian P, Wiedemann D, Borger MA. One-year outcomes of the Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve (TRITON) trial: a prospective multicenter study of rapid-deployment aortic valve replacement with the EDWARDS INTUITY Valve System. J Thorac Cardiovasc Surg. 2013 Jan;145(1):110-5; discussion 115-6. doi: 10.1016/j.jtcvs.2012.07.108. Epub 2012 Oct 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
350
April 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Carol Renner, BSN 949-250-2389 carol_renner@edwards.com
Austria,   Germany,   Switzerland
 
NCT01445171
2009-01
Yes
Edwards Lifesciences
Edwards Lifesciences
Not Provided
Study Director: Carol Renner, BSN Edwards Lifesciences
Edwards Lifesciences
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP