The objective of this study is to evaluate the safety and performance of the Trifecta* GT valve through 5 year follow-up in a prospective, multi-center, real-world setting. This study is intended to satisfy post-market clinical follow-up…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Freedom from surgical valve replacement or transcatheter valve-in-valve
implantation at 5 years post implant.
Secondary outcome
* Freedom from all-cause mortality at 5 years post implant
* Freedom from valve related mortality at 5 years post implant
* Freedom from Structural Valve Deterioration (SVD) at 5 years post implant
* Freedom from surgical valve replacement or transcatheter valve Implantation
due to SVD at 5 years post implant
* Valve hemodynamic performance (e.g. left ventricular ejection fraction, mean
and peak gradients, aortic insufficiency and effective orifice area via any
available/performed echocardiograms) at pre-discharge, 6 months, 3 years and 5
years post implant.
Background summary
SJM*s Trifecta family of aortic heart valves is used in patients with valvular
heart disease. Valvular heart disease is characterized by abnormal heart valve
function with interruption of normal blood flow through the heart. This may
result in symptoms such as fatigue, weakness, shortness of breath, chest pain
and/or heart palpitations. There are two types of heart valve disease: narrowed
heart valve and leaky heart valve. A narrowed heart valve (also known as
valvular stenosis) is characterized by a narrowed valve opening, requiring the
heart to work hard to pump blood. A leaky heart valve (also known as valvular
regurgitation) is characterized by a valve that does not close tightly. If the
valve cannot fully close, blood can leak backwards across the valve causing the
heart to work harder, resulting in less blood flow to the body. Some patients
may have a mixture of both types of heart valve disease involving one or more
of the valves.
Valvular heart disease can be congenital or may be acquired as a result of
various diseases or infections, including rheumatic fever and endocarditis.
Other causes of valvular heart disease may include, but are not limited to,
atherosclerosis, cardiomyopathy, hypertension, aortic aneurysms, and connective
tissue diseases.
Valvular heart disease is responsible for nearly 93,000 valve related
operations and 20,000 deaths each year in the United States. It is also a
contributing factor for another 42,000 deaths each year. The majority of these
cases involve disorders of the aortic valve (63%).1 Specific aortic valvular
disorders include: aortic stenosis, aortic regurgitation, or a combination of
the two, with aortic stenosis being the leading indication for aortic valve
replacement in adults.
Patients with either aortic stenosis, regurgitation, or both may remain
asymptomatic for many years. However, after the onset of symptoms (angina,
syncope, or dyspnea), the average survival is less than 2 to 3 years.2 Aortic
valve replacement (AVR) appears to be the most effective treatment for these
patients.2
For patients that need an aortic valve replacement, the Trifecta Glide
Technology (GT) aortic valve is one option. The Trifecta GT aortic heart valve
is based on the design of the predicate Trifecta valve and has minor
modifications to the sewing cuff and holder for the purpose of enhancing ease
of use and implantability. The sewing cuff was modified to have less drag when
passing sutures, less susceptibility to deformation, and improved fluoroscopic
appearance. The holder was also modified in the following ways:
1. lower profile by moving the holder legs away from the valve stent posts to
reduce bulkiness and improve access to the sewing cuff for knot tying/seating,
2. adding stent backstops on the inside of the holder to protect the stent from
potential deformation,
3. changing the holder from a click-in design to a screw-in design to reduce
overall bulkiness and accidental disengagement.
The Trifecta valve received approval in Europe on 4 March 2010, in Canada on 18
October 2010 and in the United States on 20 April 2011. The Trifecta GT valve
was approved in Europe on 1 February 2016, in Canada on 8 July 2016 and in the
United States on 24 April 2016.
Study objective
The objective of this study is to evaluate the safety and performance of the
Trifecta* GT valve through 5 year follow-up in a prospective, multi-center,
real-world setting. This study is intended to satisfy post-market clinical
follow-up requirements of CE Mark in Europe. This study is sponsored by St.
Jude Medical.
Study design
This study is a multi-center, prospective 5 year study of approximately 350
subjects intended to be implanted with a SJM Trifecta GT valve. It will be
conducted in approximately 35 sites worldwide.
Enrollment is expected to be completed within 1 year and follow-up will be 5
years for each enrolled subject. Therefore, the total duration of the study is
expected to be 6 years.
To ensure an adequate number of subjects at each site, no individual site may
enroll more than 10% of the maximum sample size (n=35 subjects) without prior
approval from the sponsor.
Study burden and risks
The Trifecta valve received approval in Europe on 4 March 2010. The Trifecta GT
valve was approved in Europe on 1 February 2016. This aortavalve is
commercially released in The Netherlands. The Trifecta GT-heart valve is an
improvement on the Trifecta valve. There is already more that 5 years follow-up
data available on the Trifecta heart valve. The risk for the patient is
comparable to any other aorta vavle replacement surgery.
This study is intended to satisfy post-market clinical follow-up requirements
of CE Mark in Europe.We evaluate the safety and performance of the Trifecta* GT
valve through 5 year follow-up in a prospective, multi-center, real-world
setting. This study is according to the requirements of the Notified Body.
Obtaining more scientific data on the aortic heart valve outweigh the
additional burden for the patient. The additional burden is 3 extra TTE at 3
additional study visits.
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Listed location countries
Age
Inclusion criteria
1. Subject is a candidate for surgical aortic valve replacement per current guidelines and is intended to be implanted with a St. Jude Medical Trifecta GT valve.
2. Subject is of legal age in the country where the subject is enrolled.
3. Subject must be willing and able to provide written informed consent to participate in this study.
4. Subject must be willing and able to comply with all follow-up requirements.
Exclusion criteria
1. Subject undergoes a concomitant procedure of mitral or tricuspid valve replacement at the time of the Trifecta GT valve implantation surgery.
2. Subject has contraindication for cardiac surgery.
3. Subject is pregnant. Pregnancy will be assessed by the subject informing the physicians.
4. Subject has active endocarditis (subjects who have previously experienced endocarditis must have two documented negative blood culture results while off antibiotic therapy prior to the valve implantation surgery).
5. Subject has had a stroke or transient ischemic attack within 6 months prior to the planned valve implantation surgery.
6. Subject is undergoing renal dialysis.
7. Subject has a history of active drug addiction, active alcohol abuse, or psychiatric hospital admission for psychosis within the prior 2 years.
8. Subject has a documented thrombus in the left atrium or left ventricle at the time of the valve implantation surgery.
9. Subject has a left ventricular ejection fraction < 30%.
10. Subject previously enrolled in the Trifecta GT PMCF study and withdrawn (a subject cannot be enrolled twice in this study).
11. Preoperative evaluation indicates other significant cardiovascular abnormalities such as aortic dissection or ventricular aneurysm.
12. Subject has a life expectancy less than 2 years.
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 | NL60274.100.16 |