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

• ClinicalTrials.gov Identifier: NCT01368666
• Recruitment Status: Unknown
• First Posted: June 8, 2011
• Last Update Posted: May 22, 2015
• Sponsor: LivaNova
• Information provided by (Responsible Party): LivaNova

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Aortic Valve Replacement	Device: Perceval S Valve Prosthesis	Phase 2; Phase 3

Detailed Description:

Primary Endpoints

The primary endpoint of the clinical investigation is the evaluation of the safety and effectiveness of the Perceval S valve at 12 months after implant.

The safety of Perceval valve will be assessed in terms of percentage incidence of mortality and morbidity at 12 months after implant.

The effectiveness of the Perceval s valve will be assessed in terms of:

• Improvement of clinical status by mean of New York Heart Association (NYHA) functional class at 12 months after implant
• Haemodynamic performance through echocardiography parameters as mean gradient and peak gradient, effective orifice area (EOA), effective orifice area indexed (EOAI), performance index, cardiac output, cardiac index and degree of regurgitation at 12 months after implant

In order to determine mortality and morbidity, the following specific device related and procedure related adverse event categories will be assessed:

- valvular thrombosis, thromboembolism, hemorrhage (whether or not related to anti coagulant/ antiplatelet drug therapy) [all and major], paravalvular leak (all and major), endocarditis, hemolysis, structural valve deterioration, non structural dysfunction, reoperation (all and valve related), explant, death (all and valve related), device dislodgement and device migration

In order to assess the Haemodynamic performance the following echocardiography parameters will be measured:

- mean gradient and peak gradient, effective orifice area (EOA), effective orifice area indexed (EOAI), performance index, cardiac output, cardiac index and degree of regurgitation

Secondary Endpoints The secondary endpoints of the clinical investigation are:

• Assessment of mortality and morbidity rates at discharge (or 30 days if the patient is still hospitalized) and at 3-6 months after implant
• Evaluation of the effectiveness of Perceval S valve in terms of improvement of clinical status assessed by means of NYHA functional class at discharge (or 30 days if the patient is still hospitalized), 3-6 months after surgery
• Evaluation of the effectiveness of Perceval S valve in terms of haemodynamic performance through echocardiography at discharge (or 30 days if the patient is still hospitalized) and 3-6 months after surgery
• Mortality and morbidity as well as haemodynamic parameters will be assessed

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 658 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Perceval S Valve Clinical Trial for Extended CE Mark
• Study Start Date: February 2010
• Actual Primary Completion Date: October 2014
• Estimated Study Completion Date: September 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Perceval S Valve Prosthesis; Patients who underwent replacement of diseased or malfunctioning native aortic valve with the Perceval S Valve prosthesis	Device: Perceval S Valve Prosthesis; Replacement of diseased or malfunctioning native aortic valve with the Perceval S valve prosthesis

Outcome Measures

Primary Outcome Measures :

1. Evaluation of the safety and effectiveness [ Time Frame: 12 months after OP ]

   Incidence of mortality and morbidity. Effectiveness: NYHA functional class and haemodynamic performance.

   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

   Haemodynamic performance : mean gradient and peak gradient, EOA, EOAI, PI, cardiac output, cardiac index and degree of regurgitation

Secondary Outcome Measures :

1. Safety and effectiveness [ Time Frame: 3-6 months ]

   The secondary endpoints of the clinical investigation are:

   • Assessment of mortality and morbidity rates at discharge and at 3-6 months after OP
   • Evaluation of the valve effectiveness in terms of improvement of clinical status assessed by means of NYHA functional class at discharge, 3-6 months after OP
   • Evaluation of the effectiveness of Perceval S valve in terms of haemodynamic performance through echocardiography at discharge and 3-6 months after surgery
   • Mortality and morbidity as well as haemodynamic parameters will be assessed

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Subjects involved in any other clinical study for drugs or devices;
2. Subjects with a previously implanted Perceval S prosthesis, within the clinical study, that requires replacement
3. Subjects with previous implantation of valve prostheses or annuloplasty ring not being replaced by the study valve
4. Subjects requiring simultaneous cardiac procedures, apart from septal myectomy and/or coronary by-pass
5. 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
6. Subjects with aneurysmal dilation or dissection of the ascending aortic wall
7. Subjects needing non elective intervention
8. Subjects with active endocarditis
9. Subjects with active myocarditis
10. Subjects with congenital bicuspid aortic valve
11. 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)
12. 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
13. Subjects with myocardial infarction < 90 days before the planned valve implant surgery
14. Subjects with known hypersensitivity to nickel alloys
15. The subject has a documented history of substance (drug or alcohol) abuse
16. The subject is a prison inmate, institutionalized, or is unable to give informed consent;
17. The subject has a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy shorter than 1 year, or the implant of the device produces an unacceptable increased risk to the patient
18. The subject is undergoing renal dialysis for chronic renal failure or has hyperparathyroidism
19. The subject has had an acute preoperative neurological deficit, myocardial infarction, or cardiac event that has not returned to baseline or stabilized ≥ 30 days prior to the planned valve implant surgery

Contacts and Locations

Locations

Austria

Universitäts-Klinik für Chirurgie

Graz, Austria, 8036

Universitätsklinik für Chirurgie

Wien, Austria, 1090

Belgium

Onze-Lieve-Vrouw (OLV) Ziekenhuis

Aalst, Belgium, 9300

UZ Leuven

Leuven, Belgium, 3000

France

CHRU de Lille

Lille, France, 59037

CHU - Nantes

Nantes, France

Institut Mutualiste Montsouris

Paris, France, 75014

Hôpital Cardiologique du Haut-Lévêque

Pessac, France, 33604

Germany

Herz- und Gefässzentrum Bad Bevensen

Bad Bevensen, Germany, 29549

RHÖN Klinikum AG, Herz- und Gefäß-Klinik GmbH

Bad Neustadt/Saale, Germany, 97616

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, Germany, 32545

Ruhr Universität Bochum

Bochum, Germany, 44789

Städtisches Klinikum Braunschweig

Braunschweig, Germany, 38126

Westdeutsches Herzzentrum

Essen, Germany, 45122

Universitäres Herzzentrum Hamburg GmbH

Hamburg, Germany, 20246

Medizinische Hochschule Hannover

Hannover, Germany, 30625

Herzzentrum Leipzig

Leipzig, Germany, 04289

Deutsches Herzzentrum

Munich, Germany, 80636

Klinikum Nürnberg Süd

Nürnberg, Germany, 90471

Klinikum Oldenburg GmbH

Oldenburg, Germany, 26133

Netherlands

Academic Medical Center, Division of Cardio-thoracic Surgery

Amsterdam, Netherlands, 1100 DE

Catharina Ziekenhuis

Eindhoven, Netherlands, 5623 EJ

St. Antonius Ziekenhuis

Nieuwegein, Netherlands, 3435

Poland

Silesian Center for Heart Diseases

Zabrze, Poland, 41800

Switzerland

Inselspital, Universitätsklinik für Herz- und Gefässchirurgie

Bern, Switzerland, 3010

United Kingdom

Genfield General Hospital

Leicester, United Kingdom, LE39QP

Sponsors and Collaborators

LivaNova

Investigators

• Principal Investigator: A. Haverich, Prof.; Hannover Medical School

More Information

• Responsible Party: LivaNova
• ClinicalTrials.gov Identifier: NCT01368666 History of Changes
• Other Study ID Numbers: TPS001
• First Posted: June 8, 2011
• Last Update Posted: May 22, 2015
• Last Verified: May 2015

Keywords provided by LivaNova:

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