To demonstrate the safety and effectiveness of the Freedom SOLO heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis. Safety will be determined by survival and complication rates. Echocardiography and…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To demonstrate
• the complication and survival rates for the SOLO valve are comparable to
appropriate historical controls manifested as objective performance criteria
(OPCs), and to that reported for other stentless bioprostheses and stented
pericardial valves in the literature;
• the hemodynamic performance of the SOLO valve is comparable to that reported
in the literature for other stentless aortic bioprostheses and stented
pericardial valves; and
• clinically significant improvement in overall patient condition by comparison
of preoperative and postoperative NYHA functional classifications.
Outcomes:
Safety endpoints:
• Safety of the SOLO valve will be evaluated based on pre-determined adverse
events related to cardiac valve replacement. Morbid events and
valve-relatedness will be determined according to guidelines for reporting
morbidity and mortality after valve surgery.
Effectiveness endpoints:
• Effectiveness of the SOLO valve will be determined by evaluation of
hemodynamic performance to assess valve function and evaluation of NYHA
classification to assess improvement in patient condition.
Secondary outcome
not applicable
Background summary
The Freedom SOLO heart valve prosthesis is a stentless bioprosthesis
manufactured with bovine pericardium stabilized by means of glutaraldehyde
treatment. The SOLO heart valve has been in clinical use since 1990 and has
shown satisfactory long-term durability compared to other prostheses. The SOLO
heart valve is designed for implant using the subcoronary technique using a
single suture line to decrease the implant time.
Study objective
To demonstrate the safety and effectiveness of the Freedom SOLO heart valve
when used to replace a diseased or dysfunctional aortic valve or aortic valve
prosthesis. Safety will be determined by survival and complication rates.
Echocardiography and overall improvement of patient condition will determine
efficacy. The results of this trial will be used to register the product in the
US and other non-European markets
Study design
The SOLO study is a prospective, not-randomized, multi-center clinical trial.
A minimum of 300 patients (at least 30 patients for each of 8 centers) will be
followed to a minimum of 1 year post-implant. 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 different time intervals:
• pre-operatively
• at implant
• in the early post-operative period (discharge or wihtin 30 days
post-operatively)
• in the late post-operative period (between 3-6 months post-operatively)
• at 1 year (between 11-13 months postoperatively)
• annually until study completion
Transthoracic echocardiographic (TTE) assessment, physical examination
(including NYHA classification) and blood tests will be performed at every
visit. A transesophageal echocardiography assessment will be performed at
implant.
Intervention
During and after the implant of the heartvalve (standaard medical preactice) a
transthoracic echocardiographic (TTE) assessment, physical examination
(including NYHA classification) and blood tests will be performed at every
visit. A transesophageal echocardiography assessment will be performed at
implant.
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 the use of the SOLO valve are not
expected to exceed the frequency and severity of those reported with other
bioprosthetic valves.
Minimization of the risks will be accomplished by selection of patients who are
appropriate candidates for implant with a bioprosthesis.
Via Crescentino s.n.
13040 Saluggia VC
IT
Via Crescentino s.n.
13040 Saluggia VC
IT
Listed location countries
Age
Inclusion criteria
Patient with pre operative evaluation indicated the need for native or prosthetic aortic valve replacement.
Any patient amenable to aortic valve replacement with biologcal prothesis, even in conjuction with valve repair, CABG and other procedures.
Patient will be available to investigator for post-operative follow up beyond one year.
Exclusion criteria
Patient has preexisting valve prosthesis in the mitral, pulmonary or tricuspid position.
Patient requires a double or triple valve replacement.
Patient had previously implanted SOLO valve within th clinical study that requires replacement.
Patient has major or progressive non-cardiac disease that, in the investigator's experience results in life expectancy of less than 1 year or the implant of the device produces an unacceptable increased risk to the patient.
Patients with congenital bicuspid aortic valve.
Patient has active endocarditis.
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 | NL26017.060.08 |