Back to results

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

Primary Purpose

Aortic Valve Stenosis With Insufficiency, Aortic Valve Stenosis

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Aortic Valve Replacement with EDWARDS INTUITY Valve System

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis With Insufficiency focused on measuring Aortic Valve Replacement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

AKH Vienna-Allgemeines Krankenhaus der Stadt Wien; University Vienna
Kerchoff Klinik-Bad Nauheim
MHH-Medizinische Hoschschule Hannover
Herzzentrum Uniklink Koln-Klinik und Poliklinik fur Herz und Thoraxzchirurgie
University Leipzig: Herzzentrum Leipzig Gmbh
Klinikum der Universitat Muchen-Grosshadern; Clinic at the University of Munich

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Study Valve

Arm Description

Subjects act as own control

Outcomes

Primary Outcome Measures

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.

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT01445171

First Posted

August 5, 2011

Last Updated

August 7, 2023

Sponsor

Edwards Lifesciences

1. Study Identification

Unique Protocol Identification Number

NCT01445171

Brief Title

Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve

Acronym

TRITON

Official Title

Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Edwards Lifesciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this clinical investigation is to confirm that the safety and performance of the 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Valve Stenosis With Insufficiency, Aortic Valve Stenosis

Keywords

Aortic Valve Replacement

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

295 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study Valve

Arm Type

Other

Arm Description

Subjects act as own control

Intervention Type

Device

Intervention Name(s)

Aortic Valve Replacement with EDWARDS INTUITY Valve System

Intervention Description

Aortic Valve bioprosthesis

Primary Outcome Measure Information:

Title

Percent of Early Adverse Events

Description

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

Time Frame

Events occuring within 30 days of procedure

Title

Percent of Late Adverse Events

Description

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Number of Subject's With Device Technical Success

Description

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

Time Frame

At time of surgery, an average of 3 hours

Title

Number of Subject's With Procedural Success

Description

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.

Time Frame

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

Title

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

Description

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.

Time Frame

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

Title

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

Description

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.

Time Frame

Baseline, 3 Months, and 1 Year post-implant

Title

Subject's Average Mean Systolic Gradient Measurements Over Time.

Description

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.

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

Title

Subject's Average Effective Orifice Area Measurements Over Time.

Description

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.

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

Title

Subject's Amount of Aortic Valvular Regurgitation Over Time

Description

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.

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

Title

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

Description

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

Time Frame