Safety and Effectiveness Study of Perceval S Valve for Extended CE Mark

NCT01368666 | Terminated DMC

• 1 other identifier: TPS001
• Study Type: interventional
• Target: 658
• Locations: 8 countries
• Sites: 26

Brief Summary

The primary objective of this clinical investigation is to assess the safety and effectiveness of the Perceval S valve at 12 months after implantation when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.

Conditions

Aortic Valve Replacement

Keywords

Aortic valve replacement; Aortic stenosis; Biological valve; Sutureless valve; Stented valve; Aortic Valve Disease

Outcome Measures

Primary Outcomes (8)

• Evaluation of the safety: incidence of mortality

  Incidence of mortality

  12 months after OP

• Evaluation of the safety: Incidence of morbidity

  Incidence of morbidity Mortality and morbidity, adverse event categories: valvular thrombosis, thromboembolism, hemorrhage, paravalvular leak, endocarditis, hemolysis, SVD, non structural dysfunction, reoperation, explant, death, device dislodgement and device migration

  12 months after OP

• Evaluation of NYHA functional class

  Change of NYHA functional class

  12 months after OP

• Evaluation of haemodynamic performance: mean and peak gradients

  Change of aortic mean gradient and peak gradient (mmHg)

  12 months after OP

• Evaluation of haemodynamic performance: Effective Orifice Area (EOA) and Effective Orifice Area indexed (EOAI)

  Change of EOA (cm2) and EOAI (cm2/m2) PI, cardiac output, cardiac index and degree of regurgitation

  12 months after OP

• Evaluation of haemodynamic performance: Cardiac Index

  Change of Cardiac Index (l/min/m2)

  12 months after OP

• Evaluation of haemodynamic performance: Cardiac Output

  Change of Cardiac Output (l/min)

  12 months after OP

• Evaluation of haemodynamic performance: incidence and degree of regurgitation

  Change of incidence (%) and degree of regurgitation (none, trace, mild, moderate, severe)

  12 months after OP

Secondary Outcomes (8)

• Evaluation of the safety: incidence of mortality

  3-6 months

• Evaluation of the safety: Incidence of morbidity

  3-6 months

• Evaluation of NYHA functional class

  3-6 months

• Evaluation of haemodynamic performance

  3-6 months

• Evaluation of the safety: Incidence of mortality

  up to 10 years

Study Arms (1)

Perceval S Valve Prosthesis

EXPERIMENTAL

Patients who underwent replacement of diseased or malfunctioning native aortic valve with the Perceval S Valve prosthesis

Device: Perceval S Valve Prosthesis

Interventions

Perceval S Valve Prosthesis DEVICE

Replacement of diseased or malfunctioning native aortic valve with the Perceval S valve prosthesis

Perceval S Valve Prosthesis

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Subjects of age \> 65 years;
• Subjects with aortic valve stenosis or steno-insufficiency;
• Subjects in which preoperative evaluation indicated the need for native or prosthetic aortic valve replacement with a biological prosthesis;
• Subjects willing to sign the informed consent;
• Subjects willing to undergo all medical follow-up, echocardiography examinations and laboratory tests planned for the Study

You may not qualify if:

• Subjects involved in any other clinical study for drugs or devices;
• Subjects with a previously implanted Perceval S prosthesis, within the clinical study, that requires replacement
• Subjects with previous implantation of valve prostheses or annuloplasty ring not being replaced by the study valve
• Subjects requiring simultaneous cardiac procedures, apart from septal myectomy and/or coronary by-pass
• Subjects who require double or multiple valve replacement or repair in whom the mitral, tricuspid, or pulmonic valve would be replaced with a non-Perceval S valve or repaired
• Subjects with aneurysmal dilation or dissection of the ascending aortic wall
• Subjects needing non elective intervention
• Subjects with active endocarditis
• Subjects with active myocarditis
• Subjects with congenital bicuspid aortic valve
• Subjects with aortic root enlargement, where the ratio between the diameter of the sino-tubular junction and the annulus diameter, assessed by TTE, is \> 1.3 (see Attachment 1 for reference)
• Subjects with aortic root height (measured from aortic annulus to sino-tubular junction) ≥ 21 mm for size 21, ≥ 22.5 mm for size 23 and ≥ 24 mm for size 25, and ≥ 25 mm for size XL/27
• Subjects with myocardial infarction \< 90 days before the planned valve implant surgery
• Subjects with known hypersensitivity to nickel alloys
• The subject has a documented history of substance (drug or alcohol) abuse

Sponsors & Collaborators

• Corcym S.r.l: lead

Study Sites (26)

Universitäts-Klinik für Chirurgie

Graz, 8036, Austria

Location

Universitätsklinik für Chirurgie

Vienna, 1090, Austria

Location

Onze-Lieve-Vrouw (OLV) Ziekenhuis

Aalst, 9300, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

CHRU de Lille

Lille, 59037, France

Location

CHU - Nantes

Nantes, France

Location

Institut Mutualiste Montsouris

Paris, 75014, France

Location

Hôpital Cardiologique du Haut-Lévêque

Pessac, 33604, France

Location

Herz- und Gefässzentrum Bad Bevensen

Bad Bevensen, 29549, Germany

Location

RHÖN Klinikum AG, Herz- und Gefäß-Klinik GmbH

Bad Neustadt an der Saale, 97616, Germany

Location

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, 32545, Germany

Location

Ruhr Universität Bochum

Bochum, 44789, Germany

Location

Städtisches Klinikum Braunschweig

Braunschweig, 38126, Germany

Location

Westdeutsches Herzzentrum

Essen, 45122, Germany

Location

Universitäres Herzzentrum Hamburg GmbH

Hamburg, 20246, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Herzzentrum Leipzig

Leipzig, 04289, Germany

Location

Deutsches Herzzentrum

Munich, 80636, Germany

Location

Klinikum Nürnberg Süd

Nuremberg, 90471, Germany

Location

Klinikum Oldenburg GmbH

Oldenburg, 26133, Germany

Location

Academic Medical Center, Division of Cardio-thoracic Surgery

Amsterdam, 1100 DE, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, 5623 EJ, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, 3435, Netherlands

Location

Silesian Center for Heart Diseases

Zabrze, 41800, Poland

Location

Inselspital, Universitätsklinik für Herz- und Gefässchirurgie

Bern, 3010, Switzerland

Location

Genfield General Hospital

Leicester, LE39QP, United Kingdom

Location

Related Publications (1)

• Fischlein T, Meuris B, Folliguet T, Hakim-Meibodi K, Misfeld M, Carrel T, Zembala M, Cerutti E, Asch FM, Haverich A; CAVALIER Trial Investigators. Midterm outcomes with a sutureless aortic bioprosthesis in a prospective multicenter cohort study. J Thorac Cardiovasc Surg. 2022 Dec;164(6):1772-1780.e11. doi: 10.1016/j.jtcvs.2020.12.109. Epub 2021 Jan 13.

  PMID: 33597099 RESULT

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• A. Haverich, Prof.

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2011
• First Posted: June 8, 2011
• Study Start: February 23, 2010
• Primary Completion: October 31, 2014
• Study Completion: January 31, 2020
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

AU (2); NL (3); FR (4); BE (2); DE (12); CH (1); GB (1); PL (1)