The objective of this clinical study is to evaluate, at six and twelve months, the hemodynamic performance of the Hancock® Ultra* bioprosthesis in the aortic position, to analyze the incidence of patient prosthesis mismatch and the correlation of…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of the study is the hemodynamic performance of the
bioprosthesis at 6 and 12 months after surgery. This will be measured by
comparing the mean aortic valve gradients pre-and post-surgery.
Secondary outcome
The secondary endpoint of the study is the incidence of patient prosthesis
mismatch (PPM). During implant, the valve size of the patient's annulus will be
measured using universal sizer and Hancock II Ultra sizer, and these
measurements will be compare to valve sizes ultimately used for implant. In
this way we can find out which valve size is most suitable for a certain native
annulus diameter.
Background summary
Since the first implant in September 1982, the Medtronic Hancock® II has
provided more than 20 years of excellent hemodynamic performance and
durability. Design improvements over the past generations include: low profile,
flexible stent, Supra-XTM supra-annular placement, T6 anticalcification tissue
treatment, modified fixation process, CINCH® advanced implant system and ULTRA
TM minimized sewing ring. Valve sizing is a critical consideration in obtaining
optimal hemodynamic performance. This is particular true in small aortic roots.
A critical issue is the size of the prosthesis in relation to the patient's
annulus.
Study objective
The objective of this clinical study is to evaluate, at six and twelve months,
the hemodynamic performance of the Hancock® Ultra* bioprosthesis in the aortic
position, to analyze the incidence of patient prosthesis mismatch and the
correlation of gradients.
Study design
Non-Interventional non-randomized multi-center prospective post-market release
clinical study.
Study burden and risks
The Hancock® Ultra * bioprosthesis used in this study are CE-marked and thus
available on the market. There are no additional risks or benefits for the
patient to participate, other than the normally associated risks of cardiac
surgery and the use of a heart lung machine. No additional or particular
diagnostic or other procedures, above normal standard of care, will be
performed on study patients as a result of participation in the study. Data
will be collected without any burden to the patient.
Endepolsdomein 5
6229 GW Maastricht
NL
Endepolsdomein 5
6229 GW Maastricht
NL
Listed location countries
Age
Inclusion criteria
- Patients who require aortic valve replacement with or without coronary artery bypass grafting or
surgical treatment of atrial fibrillation or mitral valve repair.
- Patients who are able to provide informed consent.
Exclusion criteria
- Concomitant procedures other than coronary artery bypass grafting, surgical treatment of atrial
fibrillation or mitral valve repair.
- Patients indicated for receiving a mechanical prosthesis.
- Patients who will have a replacement of existing valve prosthesis.
- Patients refusing or not able to provide informed consent.
- Patients requiring emergency surgery.
- Patients unable to participate in follow-up
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NCT01213615 |
| CCMO | NL35653.058.11 |