The objectives of the study are to evaluate the performance and safety of percutaneous implantation of the PAV. Primary endpoints will be assessed at discharge and at 30 days (acute benefits), secondary endpoints will be assessed at 3, 6, 12, 24, 36…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
· Performance is defined by device functionality based on the
investigator evaluation rating on the system and the procedure success rate at
discharge defined as a correct prosthesis valve function without any major
adverse event (MAE) at discharge (or 10 days whichever occurs first)
· Safety is defined as clinical outcome (composite of MAE including
major adverse cardiac events) at discharge and 30 days.
Secondary outcome
· Clinical : patient functional status (NYHA) from discharge until 48
month follow-up, patient neurological status (NIH stroke scale) from discharge
to 6 month follow-up. MAE from 3 month to 48 month follow-up
· Performance: valve performance , valve migration, paravalvular leak
assessed by Doppler echocardiography from 1 to 48 month follow-up,
Background summary
This study consists in proposing an alternative to the surgical valve
replacement by a mechanical or a biological prosthesis which is today the
standard practice of care of heart valve replacement. This alternative to this
open-heart surgery is a less invasive using the devices and techniques that
allow percutaneous treatment. CoreValve has developed the ReValving System
which consists of a bioprosthesis valve mounted and sutured in a self-expanding
Nitinol stent. The device is delivered percutaneously via a specific
catheter-based technique and implanted within the diseased aortic valve. The
new generation ReValving System proposed in this study allows the use of an 18
French delivery catheter and will contribute to increase the ease of valve
implantation and decrease the risk of access site complications.
Study objective
The objectives of the study are to evaluate the performance and safety of
percutaneous implantation of the PAV. Primary endpoints will be assessed at
discharge and at 30 days (acute benefits), secondary endpoints will be assessed
at 3, 6, 12, 24, 36 and 48 months follow-up.
Study design
Prospective multicenter single arm safety and performance study by Standard
EN-ISO 14155: 2003 part 1&2 on clinical research off medical devices.
Safety en performance are evaluated by discharge and after 30 days. Control of
the placement and performance after 3 and 6 months. Long term follow up off the
patient after 12, 24, 36 and 48 months.
Interim analysis after 1,3 and 6 months by echo.
Intervention
Via enterance by the arteria femoralis and a single valvuloplasty the delivery
catheter with the prosthesis will be implanted over the native aortic valve, by
controlled echo and fluoroscopy.
Study burden and risks
Possible risks and discomforts are those which can occur in association with
percutaneous implantations and in heart valve surgery: bleeding, hematoma, pain
and/or infections at the site of incision, disturbances of heart rhythm,
abnormal blood coagulation which may result in blood clots being released into
and blocking the blood stream, which in turn can lead to a heart attack or
stroke, torn vessels, unsuitable positioning of the artificial heart valve,
incorrect function of the artificial heart valve, need for a repeat
intervention, allergy to anesthetics or medications, death.
The expected benefits are due to the fact that no open heart surgery has to be
performed and that there will be none of the risks (a usually -temporary-
worsening of heart function, infection, lung, kidney or liver problems) and
discomforts associated with this type of procedure. A shorter period and an
improvement in symptoms and general condition are also expected.
Baayewei 12
4854 KC Bavel
NL
Baayewei 12
4854 KC Bavel
NL
Listed location countries
Age
Inclusion criteria
significant aortic valve stenosis, euroscore higher than 15 and/or age higher than 75 years
Exclusion criteria
previous aortic valve replacement, recent or evalutive CVA, kreatine clearance less than 20ml per minute, mitral and tricuspid insuffiency more than grade 2
Design
Recruitment
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 | NL12403.078.06 |