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

Edwards Lifesciences

Status: Completed

Conditions: Aortic Valve Stenosis; Aortic Valve Stenosis With Insufficiency

Treatments: Device: Aortic Valve Replacement with EDWARDS INTUITY Valve System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01445171

2009-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 295 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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295 participants in 1 patient group

Study Valve

Other group

Description:

Subjects act as own control

Treatment:

Device: Aortic Valve Replacement with EDWARDS INTUITY Valve System