Overview

This trial is active, not recruiting.

Conditions aortic valve stenosis with insufficiency, aortic valve stenosis
Treatment aortic valve replacement with edwards intuity valve system
Sponsor Edwards Lifesciences
Start date January 2010
End date December 2017
Trial size 295 participants
Trial identifier NCT01445171, 2009-01

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Subjects act as own control
aortic valve replacement with edwards intuity valve system
Aortic Valve bioprosthesis

Primary Outcomes

Measure
Composite of Heart valve objective performance criteria (OPC)
time frame: up to 5 years

Secondary Outcomes

Measure
Composite of Hemodynamic Performance
time frame: At each follow-up interval (up to 5 years)

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Edwards Lifesciences.