Evaluation of the morbidity and mortality rate at 3 and 12 month follow-up in patients implanted with Freedom SOLO prosthesis.
ID
Source
Brief title
Condition
- Cardiac valve disorders
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
morbidity and mortality at 3 and 12 month follow-up after aortic valve
replacement
Secondary outcome
- NYHA class at 3 and 12 month follow-up after aortic valve replacement;
- echocardiographic parameters (EOA, MPG, PPG) at preoperative time, 3 and 12
months after aortic valve replacement
- Evaluation of suturing time of the Freedom SOLO.
Background summary
The idea was to create a biological valve which looks similar to your own
native aortic valve in a healthy condition.
Freedom Solo represented an innovation in the heart valve prosthesis arena,
thanks to its unique characteristics of being a totally biological valve,
virtually identical to the native one, which can be easily implanted in a fast
way with a single suture line, giving superior results in terms of
haemodynamics.
Study objective
Evaluation of the morbidity and mortality rate at 3 and 12 month follow-up in
patients implanted with Freedom SOLO prosthesis.
Study design
This is a prospective multicentric European clinical registry.
Study burden and risks
The possible disadvantages and risks of taking part of this study are common to
all patients undergoing aortic valve replacement.
It is hoped that replacing the narrowed or leaking aortic valve with a new
artificial valve will improve the pumping action of the heart. It is not
possible to say if it is better for the patient, but the information we get
from this registry may help us decide the best treatment in the future for
patients with aortic valve disease.
Via Crescentino
Saluggia (VC) 13040
Italie
Via Crescentino
Saluggia (VC) 13040
Italie
Listed location countries
Age
Inclusion criteria
* Patients are male or female 18 years old or older;
* Patients are willing to sign the informed consent;
* Patients which preoperative evaluation indicated the need for native aortic valve replacement;
* A bioprosthesis is the most suitable alternative for replacement of a dysfunctional or diseased native aortic valve according to the current medical practice for valve selection at the centre.
Exclusion criteria
* Patients with severe evolving systemic diseases which could compromise the regular control visits or determine life expectancy minor than the duration of the study;
* Patients with ejection fraction < 30%;
* Patients with collagenophatic autoimmune disease;
* Patients affected by disorder of calcium metabolism;
* Patients with congenital malformation (bicuspid aortic valve);
* Patients with evident coronary ostia and Valsalva sinuses asymmetry;
* Patients currently participating in the study of an investigational drug or device;
* Patients who are drug abusers, alcohol abuser or unable to give informed consent;
* Patients who are HIV positive;
* Patients with active endocarditis;
* Patients required double valve replacement;
* Patients are known to be noncompliant or are unlikely to complete the study;
* Any other case in which SOLO valve is not indicated.
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 | NL14108.060.06 |