Skip to main content
OpenTrials
Completed

NCT Number: NCT01445171

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aortic Valve Stenosis With Insufficiency Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AKH Vienna-Allgemeines Krankenhaus der Stadt Wien; University Vienna, Vienna, Austria

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aortic Valve Replacement with EDWARDS INTUITY Valve System

Device

Aortic Valve bioprosthesis

Primary outcomes

  1. Percent of Early Adverse Events

    Time frame: Events occuring within 30 days of procedure

    Number of early adverse events occurring within 30 days of procedure divided by the total number of enrolled subjects times 100.

  2. Percent of Late Adverse Events

    Time frame: Events occurring >= 31 days and up through 5 years post-implant

    Number of late adverse events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).

Other outcomes

  1. Number of Subject's With Device Technical Success

    Time frame: At time of surgery, an average of 3 hours

    Device technical success is defined as the successful delivery and deployment of one bioprosthesis with one delivery system with a maximum of two attempts.

  2. Number of Subject's With Procedural Success

    Time frame: Discharge(an average of 13 days) or 10 days post-implant, whichever comes first

    Procedure success is defined as device technical success followed by the absence of adverse events requiring device reoperation, requiring implantation of permanent pacemaker, or subject death.

  3. Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline

    Time frame: 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant

    The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.

    Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).

    Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).

    Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.

    Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.

  4. Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time

    Time frame: Baseline, 3 Months, and 1 Year post-implant

    The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.

  5. Subject's Average Mean Systolic Gradient Measurements Over Time.

    Time frame: Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant

    Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.

  6. Subject's Average Effective Orifice Area Measurements Over Time.

    Time frame: Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant

    Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.

  7. Subject's Amount of Aortic Valvular Regurgitation Over Time

    Time frame: Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant

    Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.

  8. Subject's Average White Blood Cell Count Measurement Over Time.

    Time frame: Baseline, 3 Months, 1 Year, and 5 Years post-implant

    Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection.

  9. Subject's Average Red Blood Cells Count Over Time.

    Time frame: Baseline, 3 Months, 1 Year, and 5 Years post-implant

    Laboratory Analysis of Red Blood Cell Count on blood drawn from subjects; RBC carry oxygen.

  10. Subject's Average Hemoglobin Count Over Time.

    Time frame: Baseline, 3 Months, 1 Year, and 5 Years post-implant

    Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.

  11. Subject's Average Hematocrit Percentage Over Time.

    Time frame: Baseline, 3 Months, 1 Year, and 5 Years post-implant

    Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the fluid component (plasma) in the blood.

  12. Subject's Average Platelet Count Over Time.

    Time frame: Baseline, 3 Months, 1 Year, and 5 Years post-implant

    Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.

  13. Subject's Average Reticulocytes Percentage Over Time.

    Time frame: Baseline, 3 Months, 1 Year, and 5 Years post-implant

    Reticulocytes are immature red blood cells; a reticulocyte blood test measures the amount of these cells in the blood.

  14. Subject's Average Haptoglobin Measurement Over Time.

    Time frame: Baseline, 3 Months, 1 Year, and 5 Years post-implant

    Laboratory Analysis of Haptoglobin on blood drawn from subjects; Haptoglobin is a protein produced by the liver.

  15. Subject's Average Serum LDH Measurement Over Time.

    Time frame: Baseline, 3 Months, 1 Year, and 5 Years post-implant

    The lactate dehydrogenase (LDH) test looks for signs of damage to the body's tissues.

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Acronym: TRITON

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Oct 3, 2011
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.