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

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

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis; Aortic Valve Stenosis With Insufficiency
• Intervention / Treatment: Device: Aortic Valve Replacement with EDWARDS INTUITY Valve System

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.

• Study Type: Interventional
• Enrollment (Actual): 295
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • AKH Vienna-Allgemeines Krankenhaus der Stadt Wien; University Vienna
• Germany
  • Bad Nauheim, Germany, 61231
    • Kerchoff Klinik-Bad Nauheim
  • Hannover, Germany, 30625
    • MHH-Medizinische Hoschschule Hannover
  • Koeln, Germany, 50937
    • Herzzentrum Uniklink Koln-Klinik und Poliklinik fur Herz und Thoraxzchirurgie
  • Leipzig, Germany, 04289
    • University Leipzig: Herzzentrum Leipzig Gmbh
  • Munich, Germany, 81377
    • Klinikum der Universitat Muchen-Grosshadern; Clinic at the University of Munich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Study Valve; Subjects act as own control	Device: Aortic Valve Replacement with EDWARDS INTUITY Valve System; Aortic Valve bioprosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Early Adverse Events	Number of early adverse events occurring within 30 days of procedure divided by the total number of enrolled subjects times 100.	Events occuring within 30 days of procedure
Percent of Late Adverse Events	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).	Events occurring >= 31 days and up through 5 years post-implant

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subject's With Device Technical Success	Device technical success is defined as the successful delivery and deployment of one bioprosthesis with one delivery system with a maximum of two attempts.	At time of surgery, an average of 3 hours
Number of Subject's With Procedural Success	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.	Discharge(an average of 13 days) or 10 days post-implant, whichever comes first
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline	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.	1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time	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.	Baseline, 3 Months, and 1 Year post-implant
Subject's Average Mean Systolic Gradient Measurements Over Time.	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.	Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant
Subject's Average Effective Orifice Area Measurements Over Time.	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.	Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant
Subject's Amount of Aortic Valvular Regurgitation Over Time	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.	Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant
Subject's Average White Blood Cell Count Measurement Over Time.	Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection.	Baseline, 3 Months, 1 Year, and 5 Years post-implant
Subject's Average Red Blood Cells Count Over Time.	Laboratory Analysis of Red Blood Cell Count on blood drawn from subjects; RBC carry oxygen.	Baseline, 3 Months, 1 Year, and 5 Years post-implant
Subject's Average Hemoglobin Count Over Time.	Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.	Baseline, 3 Months, 1 Year, and 5 Years post-implant
Subject's Average Hematocrit Percentage Over Time.	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.	Baseline, 3 Months, 1 Year, and 5 Years post-implant
Subject's Average Platelet Count Over Time.	Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.	Baseline, 3 Months, 1 Year, and 5 Years post-implant
Subject's Average Reticulocytes Percentage Over Time.	Reticulocytes are immature red blood cells; a reticulocyte blood test measures the amount of these cells in the blood.	Baseline, 3 Months, 1 Year, and 5 Years post-implant
Subject's Average Haptoglobin Measurement Over Time.	Laboratory Analysis of Haptoglobin on blood drawn from subjects; Haptoglobin is a protein produced by the liver.	Baseline, 3 Months, 1 Year, and 5 Years post-implant
Subject's Average Serum LDH Measurement Over Time.	The lactate dehydrogenase (LDH) test looks for signs of damage to the body's tissues.	Baseline, 3 Months, 1 Year, and 5 Years post-implant

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Investigators: Study Director: Prof Axel Haverich, MHH Hannover

Publications and helpful links

General Publications

• Laufer G, Haverich A, Andreas M, Mohr FW, Walther T, Shrestha M, Rahmanian P, Holzhey D, Roth M, Schmitz C, Schramm R, Giot C, Wahlers TCW. Long-term outcomes of a rapid deployment aortic valve: data up to 5 years. Eur J Cardiothorac Surg. 2017 Aug 1;52(2):281-287. doi: 10.1093/ejcts/ezx103.
• Haverich A, Wahlers TC, Borger MA, Shrestha M, Kocher AA, Walther T, Roth M, Misfeld M, Mohr FW, Kempfert J, Dohmen PM, Schmitz C, Rahmanian P, Wiedemann D, Duhay FG, Laufer G. Three-year hemodynamic performance, left ventricular mass regression, and prosthetic-patient mismatch after rapid deployment aortic valve replacement in 287 patients. J Thorac Cardiovasc Surg. 2014 Dec;148(6):2854-60. doi: 10.1016/j.jtcvs.2014.07.049. Epub 2014 Aug 1.
• 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.
• Wahlers TCW, Andreas M, Rahmanian P, Candolfi P, Zemanova B, Giot C, Ferrari E, Laufer G. Outcomes of a Rapid Deployment Aortic Valve Versus Its Conventional Counterpart: A Propensity-Matched Analysis. Innovations (Phila). 2018 May/Jun;13(3):177-183. doi: 10.1097/IMI.0000000000000509.

Helpful Links

• New York Heart Association Classification
• Measure of Health Status Survey (EQ-5D)

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: August 5, 2011
• First Submitted That Met QC Criteria: September 30, 2011
• First Posted (Estimated): October 3, 2011

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Aortic Valve Replacement
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: 2009-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes