PERCEVAL Pivotal Trial

NCT00860730 | Completed DMC

• 1 other identifier: V10801
• Study Type: interventional
• Target: 150
• Locations: 4 countries
• Sites: 9

Brief Summary

The clinical investigation is designed as a prospective and non-randomised study on a maximum of 150 patients. This study will be conducted at Investigational Centres in the European Community. A minimum number of 8 European Centres will be involved in the clinical investigation. A minimum of 15 patients will be enrolled at each Investigational Centre. The clinical follow-up requires evaluations at discharge (or 30 days if the patient is still hospitalized), 3-6 and 12 months following the procedure.The primary objective of this clinical investigation is to assess the performance of the Perceval S valve at 3-6 months after implantation in high surgical risk patients, who require a surgical intervention to replace the aortic valve.

Conditions

Aortic Valve Replacement

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Evaluation of the safety of the Perceval S prosthesis in terms of percentage incidence of mortality and morbidity at 3-6 months after implant

  6 months

Secondary Outcomes (1)

• Assessment of mortality and morbidity rates at discharge (or 30 days if the patient is still hospitalized) and 12 months after implant

  12 months

Study Arms (1)

Perceval S

EXPERIMENTAL

Device: Aortic valve replacement with Perceval aortic heart valve

Interventions

Aortic valve replacement with Perceval aortic heart valve DEVICE

Replacement of diseased or malfunctioning native aortic valve via traditional surgery (open chest) with the Perceval S prosthesis

Perceval S

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Subjects of 75 years or older;
• Subjects with aortic valve stenosis or steno-insufficiency;
• Subjects at high surgical risk and candidates for aortic valve replacement with a biological prosthesis;
• Subjects in NYHA functional classes III and IV with the Logistic EuroSCORE greater than 5%.
• Subjects who have agreed to participation in the clinical evaluation and who have signed the informed consent;
• Subjects who are willing to undergo all the medical follow-ups and echocardiographic examinations and laboratory tests that form part of this present protocol.

You may not qualify if:

• Subjects involved in any other clinical study for drugs or devices;
• Subjects who have previously undergone implantation with the Perceval S prosthesis being assessed;
• Subjects with previous implantation of valve prostheses or annuloplasty ring in mitral position;
• Subjects requiring simultaneous procedures, apart from septal myectomy and/or coronary by-pass;
• Subjects with aneurysmal dilation or dissection of the ascending aortic wall needing surgical correction;
• Subjects needing non elective intervention;
• Subjects with aortic annulus (after procedure for decalcification) of dimensions such that the implantation of a valve of size 21 or 23 mm is not possible (direct intra-operative measurement with sizer), in accordance with the indications reported in the Investigator's Brochure;
• Subjects with active endocarditis;
• Subjects with active myocarditis;
• Subjects with any anomaly of the coronary ostia determined through pre-operative coronary angiogram or during intervention itself;
• Subjects with congenital bicuspid aortic valve;
• Subjects with aortic root enlargement, where the ratio between observed and expected diameters (calculated as a function of age and patient body surface area) is \> 1.3;
• Subjects with aortic root enlargement, where the ratio between the diameter of the sino-tubular junction and the annulus diameter is \> 1.3;
• Subjects with myocardial infarct \< =90 days;
• Subjects with known hypersensitivity to nickel alloys.

Sponsors & Collaborators

• Corcym S.r.l: lead

Study Sites (9)

UZ Leuven

Leuven, 3000, Belgium

Location

CHRU de Lille

Lille, 59037, France

Location

Hopital Guillaume et René Laennec

Nantes, 44093, France

Location

Institut Mutualiste Montsouris

Paris, 75014, France

Location

Hôpital Cardiologique du Haut-Lévêque

Pessac, 33604, France

Location

Ruhr Universität Bochum

Bochum, 44789, Germany

Location

Westdeutsches Herzzentrum

Essen, 45122, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Inselspital Bern

Bern, 3010, Switzerland

Location

Related Links

• Website

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Axel Haverich, Prof

  Hannover Medizinische Hochschule

  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: March 11, 2009
• First Posted: March 12, 2009
• Study Start: January 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2015
• Last Updated: July 8, 2022

Record last verified: 2019-01

Locations

DE (3); CH (1); FR (4); BE (1)