TerminatedNCT01368666CAVALIERUpdated Mar 6, 2024

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

An interventional study of Perceval S Valve Prosthesis in Aortic Valve Replacement, sponsored by Corcym S.r.l. Terminated at 26 sites in 8 countries. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-03-06.

Sponsored by Corcym S.r.l · Not applicable, Interventional, and Treatment

Why this study was terminated

5 years follow up completed in October 2018, long-term follow up terminated because of low data return

From the registry’s dates

Registered 1 year 3 months after the study started (first participant enrolled Feb 2010, registered Jun 2011).

Phase: Not applicable
Study type: Interventional
Enrollment: 658
Allocation: Not applicable
Ages: 65 Years and older
Sex: All

Study 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.

Read the 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

The Protocol has been amended (CAVALIER TPS001 Rev 4.0 Nov 17, 2017) to continue the follow up of a selection of implanted patients annually up to 10 years to evaluate long term device performance in the top enroller investigational sites.

The following secondary endpoints have been added:

Assessment of mortality and morbidity rates annually until 10 years follow up. 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, endocarditis, hemolysis, structural valve deterioration, non structural dysfunction, reoperation, explant, death (all and valve related), device dislodgement and device migration.
Evaluation of the effectiveness of Perceval valve in terms of improvement of clinical status assessed by NYHA change from baseline versus each follow-up up to 10 years.
Evaluation of the effectiveness of Perceval valve in terms of haemodynamic performance through echocardiography at each follow up until 10 years. 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.

Conditions studied

Aortic Valve Replacement

Keywords

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

In context

Lead sponsor

Corcym S.r.l is the lead sponsor of 10 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 65 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 658 participants (actual)

Study arms

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

Interventions

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

What researchers measure

Primary outcomes

Evaluation of the safety: incidence of mortality
Incidence of mortality
Time frame: 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
Time frame: 12 months after OP
Evaluation of NYHA functional class
Change of NYHA functional class
Time frame: 12 months after OP
Evaluation of haemodynamic performance: mean and peak gradients
Change of aortic mean gradient and peak gradient (mmHg)
Time frame: 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
Time frame: 12 months after OP
Evaluation of haemodynamic performance: Cardiac Index
Change of Cardiac Index (l/min/m2)
Time frame: 12 months after OP
Evaluation of haemodynamic performance: Cardiac Output
Change of Cardiac Output (l/min)
Time frame: 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)
Time frame: 12 months after OP

Secondary outcomes

Evaluation of the safety: incidence of mortality
Incidence of mortality
Time frame: 3-6 months
Evaluation of the safety: Incidence of morbidity
Incidence of morbidity
Time frame: 3-6 months
Evaluation of NYHA functional class
Change of NYHA functional class
Time frame: 3-6 months
Evaluation of haemodynamic performance
haemodynamic performance: mean gradient and peak gradient, EOA, EOAI, cardiac output, cardiac index and degree of regurgitation
Time frame: 3-6 months
Evaluation of the safety: Incidence of mortality
Incidence of mortality
Time frame: up to 10 years
Evaluation of the safety: Incidence of morbidity
Incidence of morbidity
Time frame: up to 10 years
Evaluation of NYHA functional class
Change of NYHA functional class
Time frame: up to 10 years
Evaluation of haemodynamic performance
haemodynamic performance: mean gradient and peak gradient, EOA, EOAI, cardiac output, cardiac index and degree of regurgitation
Time frame: up to 10 years

Study locations

26 sites

Universitäts-Klinik für Chirurgie
Graz, 8036, Austria
Universitätsklinik für Chirurgie
Wien, 1090, Austria
Onze-Lieve-Vrouw (OLV) Ziekenhuis
Aalst, 9300, Belgium
UZ Leuven
Leuven, 3000, Belgium
CHRU de Lille
Lille, 59037, France
CHU - Nantes
Nantes, France
Institut Mutualiste Montsouris
Paris, 75014, France
Hôpital Cardiologique du Haut-Lévêque
Pessac, 33604, France
Herz- und Gefässzentrum Bad Bevensen
Bad Bevensen, 29549, Germany
RHÖN Klinikum AG, Herz- und Gefäß-Klinik GmbH
Bad Neustadt An Der Saale, 97616, Germany
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, 32545, Germany
Ruhr Universität Bochum
Bochum, 44789, Germany
Städtisches Klinikum Braunschweig
Braunschweig, 38126, Germany
Westdeutsches Herzzentrum
Essen, 45122, Germany
Universitäres Herzzentrum Hamburg GmbH
Hamburg, 20246, Germany
Medizinische Hochschule Hannover
Hannover, 30625, Germany
Herzzentrum Leipzig
Leipzig, 04289, Germany
Deutsches Herzzentrum
Munich, 80636, Germany
Klinikum Nürnberg Süd
Nürnberg, 90471, Germany
Klinikum Oldenburg GmbH
Oldenburg, 26133, Germany
Academic Medical Center, Division of Cardio-thoracic Surgery
Amsterdam, 1100 DE, Netherlands
Catharina Ziekenhuis
Eindhoven, 5623 EJ, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, 3435, Netherlands
Silesian Center for Heart Diseases
Zabrze, 41800, Poland
Inselspital, Universitätsklinik für Herz- und Gefässchirurgie
Bern, 3010, Switzerland
Genfield General Hospital
Leicester, LE39QP, United Kingdom

References and documents

Publications

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. PubMed 33597099 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01368666
Lead sponsor: Corcym S.r.l
Responsible party: Sponsor
First posted: Jun 8, 2011
Start date: Feb 23, 2010
Primary completion: Oct 31, 2014
Completion: Jan 31, 2020
Last update: Mar 6, 2024

Study contacts

A. Haverich, Prof.

principal investigator · Hannover Medical School

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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