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

Edwards Lifesciences295 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

295

Conditions

Aortic Valve Stenosis With Insufficiency Aortic Valve Stenosis

Interventions

Aortic Valve Replacement with EDWARDS INTUITY Valve SystemDEVICE

Aortic Valve bioprosthesis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

AKH Vienna-Allgemeines Krankenhaus der Stadt Wien; University Vienna

Vienna, Austria

Kerchoff Klinik-Bad Nauheim

Bad Nauheim, Germany

Herzzentrum Uniklink Koln-Klinik und Poliklinik fur Herz und Thoraxzchirurgie

Cologne, Germany

MHH-Medizinische Hoschschule Hannover

Hanover, Germany

Outcomes

Primary Outcomes

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.

Time frame: 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).

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

Data from ClinicalTrials.gov

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