Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement

Stopped early · Not applicable

Conditions studied: Aortic Valve Disease, Aortic Stenosis

In brief

Prospective, randomized, stratified non blinded multi-center, international, post market trial assessed in a non-inferiority study. The trial has a flexible sample size that will be determined adaptively. The trial will enroll up to 1234 subjects, but accrual may stop earlier at approximately 900 or 1050 subjects These subjects will be enrolled at approximately 60 worldwide investigational sites where the device is commercially available The primary objective of this trial is to test the safety and efficacy of Perceval versus standard sutured stented bioprosthetic aortic valves among the intended trial population.

Key facts

Study ID

NCT02673697

Run by

Corcym S.r.l

People needed

914

Starts

2016-03-22

Expected to finish

2020-07-31

Last updated by the study team

2024-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject has an indication for treatment by valve replacement with a bioprosthesis according to the IFU, through either full sternotomy or mini-sternotomy.
• The subject has aortic valve disease that can be treated with a commercially available Perceval valve size, based on preoperative CT-scan.
• The subject has:
• critical aortic valve area defined as an initial aortic valve area of ≤1.0 cm2 or aortic valve area index < 0.6 cm2/m2 AND
• Mean gradient > 40 mmHg or Vmax > 4 m/sec by resting echocardiogram or simultaneous pressure recordings at cardiac catheterization [or with dobutamine stress, if subject has a left ventricular ejection fraction (LVEF) <55%] or velocity ratio < 0.25;
• The subject is symptomatic due to aortic stenosis with functional class of New York Heart Association (NYHA) II or higher.
• The subject has signed the informed consent.
• The subject is of legal minimum age.
• The subject will be available for postoperative follow-up beyond one year.

You may not qualify if…

• The subject has a contraindication for treatment by the Perceval valve or by a bioprosthetic aortic valve as stated in the IFU.
• The subject has aneurismal dilation or dissection of the ascending aortic wall.
• The subject is scheduled for concomitant procedures other than Coronary Aortic Bypass Graft (CABG), myectomy with or without aortic annulus enlargement
• The subject has congenital bicuspid (i.e. Sievers type 0) or unicuspid aortic valve.
• Anatomical structures not suitable for Perceval valve such as: aortic root enlargement, where the ratio between the diameter of the sino-tubular junction and the annulus diameter is > 1.3.
• The subject has a prosthetic heart valve in any position, including mitral valve repair.
• The subject has a stroke or myocardial infarction (STEMI and NSTEMI) within 30 days prior to the planned valve implant surgery.
• The subject has active endocarditis, myocarditis, or sepsis.
• The subject is in cardiogenic shock manifested by low cardiac output and needing hemodynamic support.
• The subject is allergic to nickel alloys.
• The subject is already included in another clinical trial that could confound the results of this clinical investigation.

Where it is running

• St. Vincent Heart Center of Indiana — Indianapolis, Indiana, United States
• Maine Medical Center — Portland, Maine, United States
• Heart and Vascular Institute, Cleveland Clinic — Cleveland, Ohio, United States
• Houston Methodist Research Institute, Houston Methodist Hospital — Houston, Texas, United States
• Valley Health System — Winchester, Virginia, United States
• Klinische Abteilung fuer Herzchirurgie — Graz, Austria
• Medical University of Innsbruck — Innsbruck, Austria
• Herzzentrum Hietzing — Vienna, Austria
• Medical University of Vienna — Vienna, Austria
• Universitair Ziekenhuis Antwerpen — Antwerp, Belgium
• Cliniques Univ. Saint-Luc — Brussels, Belgium
• Universitair Ziekenhuis — Leuven, Belgium
• University of Alberta — Edmonton, Alberta, Canada
• Southlake Regional Health Centre — Newmarket, Ontario, Canada
• Montreal Heart Institute — Montreal, Quebec, Canada
• Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval — Québec, Canada
• Hospital Clinico San Borja Arriaran — Santiago, Chile
• CHU Angers — Angers, France
• C.H.U. de Besançon — Besançon, France
• Hôpital privé de Bois Bernard — Bois-Bernard, France
• Chru De Lille — Lille, France
• CHU Arnaud de Villeneuve — Montpellier, France
• C.H.U. de Nancy — Nancy, France
• CHU de Poitiers — Poitiers, France
• Herzzentrum Bad Krozingen — Bad Krozingen, Germany

Full record on ClinicalTrials.gov

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