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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.
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT01445171
First received: August 5, 2011
Last updated: November 19, 2015
Last verified: November 2015

August 5, 2011
November 19, 2015
January 2010
December 2017   (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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
295
June 2018
December 2017   (final data collection date for primary outcome measure)

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 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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany
Switzerland
 
NCT01445171
2009-01
Yes
Not Provided
Not Provided
Edwards Lifesciences
Edwards Lifesciences
Not Provided
Study Director: Prof Axel Haverich MHH Hannover
Edwards Lifesciences
November 2015

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