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Trial record 2 of 3 for:    PERCEVAL

PERCEVAL Pivotal Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sorin Group
ClinicalTrials.gov Identifier:
NCT00860730
First received: March 11, 2009
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Aortic Valve Replacement
Device: Aortic valve replacement with Perceval aortic heart valve

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PERCEVAL Pivotal Trial

Resource links provided by NLM:


Further study details as provided by Sorin Group:

Primary Outcome Measures:
  • Evaluation of the safety of the Perceval S prosthesis in terms of percentage incidence of mortality and morbidity at 3-6 months after implant [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assessment of mortality and morbidity rates at discharge (or 30 days if the patient is still hospitalized) and 12 months after implant [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 150
Study Start Date: January 2009
Estimated Study Completion Date: May 2015
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Perceval S Device: Aortic valve replacement with Perceval aortic heart valve
Replacement of diseased or malfunctioning native aortic valve via traditional surgery (open chest) with the Perceval S prosthesis

Detailed Description:

The design of the Perceval S prosthesis stems from the intention to offer an alternative to traditional flexible prostheses (stented and stentless biological valves) using conventional open-heart surgery. As a result of the sutureless implant procedure, in fact, patients could benefit from:

Reducing aortic clamp times, with subsequent overall reduction of surgical timing and therefore reduction in related risks; Avoiding to pass the stitches through the annulus and sutures knotting, with consequent less risk of tearing aortic annulus and wall, damaging the bundle of His, embolizing foreign material in the vascular system.

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860730

Locations
Belgium
UZ Leuven
Leuven, Belgium, 3000
France
CHRU de Lille
Lille, France, 59037
Hopital Guillaume et René Laennec
Nantes, France, 44093
Institut Mutualiste Montsouris
Paris, France, 75014
Hôpital Cardiologique du Haut-Lévêque
Pessac, France, 33604
Germany
Ruhr Universität Bochum
Bochum, Germany, 44789
Westdeutsches Herzzentrum
Essen, Germany, 45122
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Switzerland
Inselspital Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
Sorin Group
Investigators
Principal Investigator: Axel Haverich, Prof Hannover Medizinische Hochschule
  More Information

Additional Information:
No publications provided

Responsible Party: Sorin Group
ClinicalTrials.gov Identifier: NCT00860730     History of Changes
Other Study ID Numbers: V10801
Study First Received: March 11, 2009
Last Updated: May 15, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: German Institute of Medical Documentation and Information
Belgium: Federal Agency for Medicinal Products and Health Products
Switzerland: Swissmedic

Keywords provided by Sorin Group:
Aortic valve replacement
Aortic stenosis
Biological valve
Sutureless valve
Stented valve
Aortic Valve Disease

ClinicalTrials.gov processed this record on November 20, 2014