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. The…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety endpoints:
- Safety of the Perceval S-valve will be evaluated based on pre-determined
adverse events related to cardiac valve replacement. Morbidity and
valve-relatedness will be determined according to specific guidelines for
reporting morbidity after valve surgery.
Effectiviness endpoints:
Effectiviness of the Perceval S-valve will be determined by evaluation of
hemodynamic performance to assess valve function of NYHA-classification to
assess improvement in patient condition.
Secondary outcome
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-classification 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.
Background summary
Perceval S is a prosthetic valve comprising a stabilised functional component
in bovine pericardium, assembled to a super-elastic metal alloy armature
(Nitinol stent). A special feature of the device is that it doesn*t need
sutures to be fixed to the implant site. This function is accomplished by the
armature, which therefore has the dual role of valve support and secure
anchorage to the aortic root.
The sponsor has completed a Pilot-Study (First In Man) aimed at demonstrating
the 30-days safety of the Perceval S-valve in high risk patient.
Based on these results, the sponsor designed a new trial aimed at:
- confirming the safety and performance results in a larger patient population;
- obtaining CE-mark with limited indication.
This study is currently ongoing.
Study objective
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.
The safety will be assessed in terms of percentage incidence of mortality and
morbidity at 12 months after implant.
The effectiveness will be assessed in terms of:
- Improvement of clinical status by mean of the NYHA-classification at 12
months after implant.
- echocardiography parameters to research the haemodynamic improvement.
Study design
Cavalier study is a prospective, non-randomised. multicentre, European clinical
trial.
A minimum of 300 patients ( a minimum of 15 patient in 8 centers) will be
followed to a minimum of one year postimplant. As necessary, additional
patients will be implanted and followed until the requirement of 800
valve-years of experience is achieved.
Patients will be evaluated at each of the following time intervals:
· pre-operatively,
· at implant,
· in the early postoperative period (at hospital discharge or within 30 days
postoperatively),
· in the late postoperative period (between 3 and 6 months postoperatively),
· at 1 year (between 11 and 13 months postoperatively),
· annually until study completion.
Intervention
Beside the implantation (standard treatment) a Transthoracic echocardiography
(TTE) assessment, clinical examination (incl. NYHA-classification) and
haematological analysis will be performed during each visit. A transesophageal
echo (TEE) will also be performed intraoperatively.
Study burden and risks
The most obvious benefit from implant of a bioprosthetic valve is overall
improvement in patient condition as a result of improved heart valve function.
The risks and discomforts associated with het use of the Perceval S valve are
not expected to exceed the frequency and severity of those reported with other
bioprosthetic valves. However, the implant of the Perceval-S valve can possibly
lead to a slightly higher risk of a paravalvulair leak. Theoratically, there is
a minor change of valve migration. Minimization of the risks will be
accomplished by selection of patients who are appropriate candidates for
implant with a bioprosthesis. As a result of the sutureless implant procedure
of the Perceval S-valve prosthesis, benefits from reduced cross-clamp time and
consequently duration of extracorporeal circulation are expected.
Via Crescentino s.n.
13040 Saluggia VC
IT
Via Crescentino s.n.
13040 Saluggia VC
IT
Listed location countries
Age
Inclusion criteria
Subjects of age 65 (or older) 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;
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;
Subjects with aneurysmal dilation or dissection of the ascending aortic wall;
Subjects with active endocarditis, myocarditis;
Subjects with congenital bicuspid aortic valve;
Subjects with myocardial infarction < 90 days before the planned valve implant surgery;
Subjects with known hypersensitivity to nickel alloys.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL31492.060.10 |