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

Not Applicable

Completed

• Conditions: Aortic Valve Stenosis; Aortic Valve Stenosis With Insufficiency
• Interventions: Device: Aortic Valve Replacement with EDWARDS INTUITY Valve System

• Registration Number: NCT01445171
• Lead Sponsor: Edwards Lifesciences

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2011-08-05
• Study First Submitted QC: 2011-09-30
• Study First Posted: 2011-10-03
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Results First Submitted: 2020-01-15
• Results First Submitted QC: 2020-02-06
• Results First Posted: 2020-02-17
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 295

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Valve	Aortic Valve Replacement with EDWARDS INTUITY Valve System	Subjects act as own control

Primary Outcome Measures

Name	Time	Method
Percent of Early Adverse Events	Events occuring within 30 days of procedure	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	Events occurring >= 31 days and up through 5 years post-implant	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).

Trial Locations

Locations (6)

MHH-Medizinische Hoschschule Hannover; 🇩🇪 Hannover, Germany

Kerchoff Klinik-Bad Nauheim; 🇩🇪 Bad Nauheim, Germany

University Leipzig: Herzzentrum Leipzig Gmbh; 🇩🇪 Leipzig, Germany

Klinikum der Universitat Muchen-Grosshadern; Clinic at the University of Munich; 🇩🇪 Munich, Germany

Herzzentrum Uniklink Koln-Klinik und Poliklinik fur Herz und Thoraxzchirurgie; 🇩🇪 Koeln, Germany

AKH Vienna-Allgemeines Krankenhaus der Stadt Wien; University Vienna; 🇦🇹 Vienna, Austria