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Status:

COMPLETED

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

Lead Sponsor:

Edwards Lifesciences

Conditions:

Aortic Valve Stenosis With Insufficiency

Aortic Valve Stenosis

Eligibility:

All Genders

18+ years

Phase:

NA

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 assess...

Eligibility 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

  • 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

Key Trial Info

Start Date :

January 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2017

Estimated Enrollment :

295 Patients enrolled

Trial Details

Trial ID

NCT01445171

Start Date

January 1 2010

End Date

December 1 2017

Last Update

September 1 2023

Active Locations (6)

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Page 1 of 2 (6 locations)

1

AKH Vienna-Allgemeines Krankenhaus der Stadt Wien; University Vienna

Vienna, Austria, 1090

2

Kerchoff Klinik-Bad Nauheim

Bad Nauheim, Germany, 61231

3

Herzzentrum Uniklink Koln-Klinik und Poliklinik fur Herz und Thoraxzchirurgie

Cologne, Germany, 50937

4

MHH-Medizinische Hoschschule Hannover

Hanover, Germany, 30625