The objective is to collect additional data on the clinical outcomes (surgical data, safety and clinical performance) of the Medtronic Enable® Aortic Bioprosthesis in *real world* patients. The collected data will be used to improve aortic valve…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Hemodynamic performance of the Medtronic Enable aortic bioprosthesis at
discharge, within 6 months following implantation, 1 year and annually
thereafter up to 5 years post-implant.
- New York Heart Association (NYHA) classification
- Safety: includes all Serious Adverse Events (SAEs) and (Serious) Adverse
Device Effects (ADEs/SADEs).
These variables will be evaluated by comparison with the baseline data and with
published data in the literature.
Secondary outcome
Not applicable.
Background summary
The Medtronic Enable® sutureless aortic bioprosthesis (model 6000) was first
implanted in February 2007. The Medtronic Enable® sutureless aortic
bioprosthesis is commercially available and has received CE-mark in December
2009.
The Enable® aortic bioprosthesis is developed for aortic valve replacement
(AVR) and is intended for use in patients whose aortic valvular disease is
sufficiently advanced to warrant replacement of their native valve with a
prosthetic device. The usual conditions of advanced disease are aortic
stenosis, aortic insufficiency or a combination of the two.
The Enable aortic bioprosthesis consists of the following:
• The 3f Aortic Bioprosthesis* Model 1000, (commercially available in Europe)
assembled from three equal sections of equine pericardial material that have
been cross-linked with formulations of low concentration glutaraldehyde under
specific parameters of time, pH and temperature. This fixation process
preserves the collagen architecture of the pericardial material, minimizes the
immunogenic potential of the xenogeneic tissue and preserves flexibility and
strength.
• A self-expanding Nitinol frame covered with polyester fabric on the inflow
aspect
The self-expanding Nitinol frame, allows for a quick fixation of the Enable
valve in the aortic annulus without suturing (sutureless-concept).
Consequently, the Enable implant time will be significantly reduced, which will
shorten the cardiopulmonary bypass time.
Clinical experience has shown that aortic valve replacement with Medtronic
Enable aortic bioprosthesis is safe, that the hemodynamic performance of the
Enable bioprosthesis is very good and that the operation time is significantly
shortened due to the quick fixation of the Enable in the aortic annulus.
Study objective
The objective is to collect additional data on the clinical outcomes (surgical
data, safety and clinical performance) of the Medtronic Enable® Aortic
Bioprosthesis in *real world* patients.
The collected data will be used to improve aortic valve replacements for other
patients.
Study design
Non-interventional, non-randomized, prospective, multi-center post-market
release (PMR) study.
The data will be collected at discharge, within 6 months following
implantation, 1 year and annually thereafter up to 5 years post-implant.
Study burden and risks
The Medtronic Enable aortic bioprostheses used in this study, has CE-mark and
are released for distribution at the moment of study start. Medtronic is not
aware of any significant problems with this product. In the study, the products
will be used in accordance with their labeling, therefore no risks other than
the risks typically associated with a routine device implantation and
follow-ups are anticipated.
In addition subjects are treated according to general clinical practice, so no
extra tests and follow-ups are required. Therefore, no additional risks are
associated with participation in this study.
Endepolsdomein 5
Maastricht 6229 GW
NL
Endepolsdomein 5
Maastricht 6229 GW
NL
Listed location countries
Age
Inclusion criteria
1. Patient with aortic valve stenosis, aortic valve insufficiency or a combination of the two.
2. Patient requires replacement of his/her native aortic valve with a bioprosthesis with or
without concomitant procedures.
3. Patient is above the minimum age as required by local regulations to be participating in
a clinical study.
4. Patient is willing to return to the implant site for follow-up visits.
5. Patient has been adequately informed of this clinical study and is willing to sign the
patient Data Release Form.
Exclusion criteria
1. Patient requires replacement of two or more valves.
2. Patient who underwent previous aortic valve replacement (AVR).
3. Patient with native bicuspid aortic valve.
4. Patient with active endocarditis or other systemic infection.
5. Patient dilatation of the ascending aorta, deformations or irregular aortic annulus or
ascending aorta geometry as seen via preoperative imaging.
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 |
|---|---|
| ClinicalTrials.gov | NCT01720342 |
| CCMO | NL42349.058.12 |