Study Purpose and ObjectivesStudy PurposeTo confirm the clinical safety and effectiveness of the Trifecta valve by establishing associated adverse event rates, clinical status as indicated by NYHA functional classification, hemodynamic performance,…
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Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety Endpoints
1. Morbidity and mortality are evaluated by early rates, linearized rates,
Kaplan-Meier life tables and Cox Proportional Regression for the following
adverse events: hemolysis (clinically significant), nonstructural dysfunction,
paravalvular leak, structural deterioration/failure, major bleeding events
(whether or not related to drug therapy), anticoagulant related hemorrhage,
embolism (valve-related), endocarditis, valve thrombosis, reoperation, explant,
and death (all and valve-related).
2. The primary analysis is to compare the observed event rates to the OPC. When
any of the sequential analyses demonstrate the posterior probability that the
event rate is less than 2*OPC is larger than 0.80 and the posterior probability
that the event rate is less than the OPC is at least 0.20 for all 6
classifications then the Trifecta valve will be considered successful
(reference Primary Statistical Analysis section of Appendix F).
Effectiveness Endpoints
1. Percentage of patients in each NYHA functional classification at baseline
(preoperatively) and at follow-up intervals, and the percentage of patients
improving, not changing, or worsening in NYHA functional classification at each
follow-up time point.
2. Mean, standard deviation, minimum and maximum values for mean gradient, peak
gradient, effective orifice area, effective orifice area index, cardiac output,
cardiac index, and performance index will be evaluated. Percentage of patients
for the incidence/severity of aortic insufficiency as determined by
echocardiography by location (central and paravalvular leak) will be provided.
All echocardiography data will be presented by valve size.
3. Mean, standard deviation, minimum and maximum values for hemoglobin,
hematocrit, white blood cell count, red blood cell count, and plasma free
hemoglobin will be evaluated. Normalized data will be based on blood normals
from the blood core lab. In addition, the percentage of blood values that are
below, within, or above the specified normal range will be evaluated by valve
size.
Secondary outcome
nvt
Background summary
To provide an additional bioprosthetic valve choice to physicians, St. Jude
Medical has developed the Trifecta valve. The Trifecta valve is a tri-leaflet
stented pericardial valve designed for supra-annular placement in the aortic
position. The valve leaflets are fabricated from bovine pericardial tissue and
the valve incorporates a porcine pericardial tissue covering on the stent to
prevent contact between the valve leaflets and the polyester covered stent.
The Trifecta valve is processed using Linx* anticalcification technology.
The leaflets of the Trifecta valve are uniquely mounted on the outside of the
valve stent providing a large opening area which results in superior
hydrodynamics as compared to a currently marketed stented pericardial valve
(reference Table 1). The porcine pericardial tissue covering on the Trifecta
valve stent minimizes the potential for wear by allowing only tissue-to-tissue
contact. Additionally, the Linx* anticalcification treatment of the Trifecta
valve may aid in minimizing tissue calcification, which is a primary failure
mode in bioprostheses.10
Table 1: In-Vitro Pulsatile Flow Results
Trifecta Valve
(n=5 per valve size) Currently Marketed Stented Pericardial Valve (Control
Valve)
(n=1 per valve size)
Aortic Valve Size Mean Pressure Gradient
(mm Hg) EOA (cm2) Mean Pressure Gradient
(mm Hg) EOA (cm2)
19 mm 8.0 1.8 15.6 1.3
21 mm 6.0 2.2 -- --
23 mm 4.1 2.7 -- --
25 mm 2.3 3.5 4.5 2.6
27 mm 2.0 3.9 -- --
29 mm 1.7 4.4 2.5 3.5
Note: The pulsatile flow results were from measurements conducted at a pulse
rate of 70 beats/min, a nominal cardiac output of 5.0 liters/min, and a back
pressure of 100mm Hg.
Study objective
Study Purpose and Objectives
Study Purpose
To confirm the clinical safety and effectiveness of the Trifecta valve by
establishing associated adverse event rates, clinical status as indicated by
NYHA functional classification, hemodynamic performance, and hematology
analysis.
Safety Objective
To establish adverse event rates as compared to a set of Objective Performance
Criteria (OPC).
Effectiveness Objectives
1. To characterize patient NYHA functional classification status.
2. To characterize the hemodynamic performance of the valve, as per
echocardiography.
Study design
Study Design Overview
The clinical investigation is a multi-center, multi-country, prospective,
non-randomized, observational study without concurrent or matched controls,
designed to evaluate the safety and effectiveness of the Trifecta valve. A
maximum of 120 subjects requiring aortic valve replacement will be implanted at
a maximum of 3 investigational sites in Europe. The sample size is based on
late patient-years of follow-up with a minimum of 400 late patient-years
experience required. A comparable study is being conducted in the United States
and Canada. Data from a maximum of 7 Canadian sites and 18 U.S. sites may be
used.
This study will be conducted in accordance with the requirements provided in
ISO 5840: 2005(E).
Patients satisfying inclusion/exclusion criteria and have signed informed
consent will undergo a preoperative baseline evaluation that includes NYHA
functional classification determination, blood tests, and a general clinical
assessment.
Those patients who are successfully implanted with the Trifecta valve will have
an echocardiogram, blood tests, and a general clinical assessment conducted at
discharge or 30 days post-implant (whichever occurs first). Additional
follow-up at 6 months, 12 months, and annually thereafter will include an
echocardiogram, NYHA classification determination, blood tests, and a general
clinical assessment. All patients will have annual follow-up visits until the
CE mark for the Trifecta valve has been approved or denied by the applicable
regulatory agencies or as otherwise requested by regulators, study
investigators, or the Data Monitoring Committee.
Study burden and risks
Potential benefits to the subjects may include, but are not limited to, relief
of valvular stenosis and/or incompetence and related symptoms. A subject may
benefit from the improved longevity of the valve, due to the Linx* treatment of
the Trifecta valve (if the Linx* treatment is proven effective). In addition,
similar benefits may accrue to future subjects through experience gained in
this investigation.
Subjects participating in this study are not expected to be at any higher or
additional risk than those commonly associated with the implant of a prosthetic
heart valve. There are risks with any heart valve replacement. These may
include, but are not limited to angina, bleeding events (including
perioperative bleeds), cardiac arrhythmias, death (valve and non-valve
related), embolism, endocarditis, explant, heart failure, hemolysis, hemolytic
anemia, myocardial infarction, nonstructural dysfunction, paravalvular leak,
regurgitation, reoperation, stroke, structural deterioration, valve thrombosis,
valvular pannus or other serious adverse events
Animal studies conducted on the Trifecta valve demonstrated survival rates
comparable to a currently marketed stented pericardial valve (control valve).
These results provide evidence of safety and show promise for long-term
clinical durability (reference Appendix J).
Additionally, durability testing was conducted on the Trifecta valve utilizing
SJM's accelerated life testers in accordance with the test criteria specified
in the Food and Drug Administration (FDA) Heart Valve Guidance and ISO 5840.
Durability testing conducted on the Trifecta valve was carried out to 200
million cycles simulating 5 years of use. As a reference, three control valves
were also exposed to the same conditions; Carpentier-Edwards Pericardial
Bioprothesis Model 2700 (aortic sizes 19, 25, and 29mm).
The durability test results demonstrate that there was no significant wear of
the Trifecta valve out to 200 million cycles. One control valve failed
durability testing prior to 200 million cycles and two passed.
For burden: see study design for follow up visits for the patients.
Standaardruiter 13
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Listed location countries
Age
Inclusion criteria
1. Patient requires aortic valve replacement. (Note: patients undergoing concomitant procedures, e.g. coronary artery bypass grafting, or valve repair, are eligible for this study).
2. Patient is legal age in host country.
3. Patient (or legal guardian) has given written informed consent for participation prior to surgery.
4. Patient is willing to undergo all study procedures and adhere to data collection and follow-up requirements.
Exclusion criteria
1. Patient is pregnant or nursing (women of child bearing potential must have a documented negative pregnancy test within one week prior to surgery).
2. Patient already has a prosthetic valve(s) at a site other than the aortic valve.
3. Patient requires concomitant replacement of the tricuspid, pulmonary, or mitral valve.
4. Patient has an inability or is unwilling to return for the required follow-up visits.
5. Patient has active endocarditis (patients with previous endocarditis must have two documented negative blood culture results prior to enrollment).
6. Patient has had an acute preoperative neurological event defined as patient has not returned to baseline or has not stabilized 30 days prior to the planned valve implantation surgery.
7. Patient is undergoing renal dialysis.
8. Patient has a documented history of substance abuse within one year of enrollment.
9. Patient is currently participating in the study of an investigational drug or device, or the patient was previously participating in an investigational drug study and has not completed a 30-day wash out period.
10. Patient had the Trifecta valve implanted as part of this study, but then had the device explanted.
11. Preoperative evaluation indicates other significant cardiovascular abnormalities such as aortic dissection or ventricular aneurysm.
12. Patient has a life expectancy less than two years.
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 |
|---|---|
| ClinicalTrials.gov | NCT00727181 |
| CCMO | NL24476.100.08 |