Safety and Effectiveness Study of Perceval S Valve for Extended CE Mark - Full Text View

Purpose

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	Intervention	Phase
Aortic Valve Replacement	Device: Perceval S Valve Prosthesis	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Perceval S Valve Clinical Trial for Extended CE Mark

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Aortic Valve Stenosis

U.S. FDA Resources

Further study details as provided by LivaNova:

Primary Outcome Measures:

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:

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


Enrollment:	658
Study Start Date:	February 2010
Estimated Study Completion Date:	September 2018
Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Eligibility


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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
The subject is a prison inmate, institutionalized, or is unable to give informed consent;
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
The subject is undergoing renal dialysis for chronic renal failure or has hyperparathyroidism
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

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: NCT01368666

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
Study First Received:	June 7, 2011
Last Updated:	May 21, 2015

Keywords provided by LivaNova:


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

ClinicalTrials.gov processed this record on September 18, 2017

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