The purpose of this study is to assess the safety and performance of the SJM Portico Transcatheter Heart Valve and the SJM TAVI Transfemoral Transcatheter delivery system in subjects with severe symptomatic aortic stenosis (AS).
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is all cause mortality at 30 days.
Secondary outcome
1. The event rates at 30 days of the following:
• Cardiovascular mortality
• Myocardial Infarction (MI)
• Disabling stroke (Major Stroke)
• Non-disabling stroke (Minor Stroke)
• Acute kidney injury (AKI)
• Vascular access site and access-related complications
• Bleeding
• Composite of
o periprocedural encephalopathy
o all stroke
o all TIA
2. Functional improvement from baseline as compared to 30 days by:
a. NYHA Functional Classification
b. Six Minute Walk Test
c. Effective Orifice Area (EOA)
3. Acute device success defined as:
a. Successful vascular access, delivery and deployment of the device
and successful retrieval of the delivery system
b. Correct position of the device in the proper anatomical location
c. Intended performance of the prosthetic heart valve (Aortic Valve
Area >1.2 cm2 and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s,
without moderate or severe prosthetic valve AR)
d. Only one valve implanted in the proper anatomical location
Background summary
Calcific aortic valve stenosis is a common cardiovascular disease, with an
increasing incidence in an aging population. In
cases of severe aortic stenosis, patients develop symptoms and functional
limitation unavoidably followed by physical
deterioration, heart failure and poor prognosis.
For many decades, surgical aortic valve replacement has been an effective
treatment improving symptoms and survival, but
more than one-third of patients with symptomatic severe aortic stenosis do not
undergo surgery because of a high surgical
risk; these patients are not referred, are refused or are declined surgery.
Though some of these patients may be candidates for balloon valvuloplasty, this
procedure has not offered any improvement in mortality.
Transcatheter aortic valve implantation (TAVI), first performed in 2002, has
permitted the treatment of patients with excessive
surgical risk. Since the first TAVI case in 2002, 50.000 transcatheter aortic
valve procedures have been performed worldwide
comparing favorably with surgery in selected cohorts of patients; TAVI being
the only intervention for inoperable aortic stenosis
that demonstrated to prolong life in a randomized study. Various groups have
now reported their early experiences with balloon expandable and
self-expandable percutaneous heart valves (PHVs). There are currently as many
as 17 PAVR programs in active research, and among those, there are 2 PAVR
prostheses in clinical trials, at least 7 more with FIM implant results, and
others at different stages of investigation.
Several studies have also reported symptomatic improvement in the short term
and midterm after TAVI. However, nearly 20% of patients experienced no
symptomatic improvement highlighting
Aortic Regurgitation (AR) as the most frequent complication and one of the main
factors affecting symptoms and survival.
The results of recent multicenter trials using either the Edwards SAPIEN valve
or CoreValve Revalving System have shown that the procedure is safe and
effective. Moreover, in the majority of series, the two technologies were
associated with success rates >90% and 30-day procedural mortality rates <10%
even though the trials involved high-risk patients.
As summarized above in the cited literature, high risk patients are often
unable to tolerate a full surgical valve replacement due to comorbidities or
frailty. TAVI is a viable option due to quicker recovery times as compared to
surgical aortic valve replacement. The Portico Transcatheter Heart Valve is
the only valve that allows for resheathability, which helps achieve optimal
placement.
Study objective
The purpose of this study is to assess the safety and performance of the SJM
Portico Transcatheter Heart Valve and the SJM TAVI Transfemoral Transcatheter
delivery system in subjects with severe symptomatic aortic stenosis (AS).
Study design
This is a multicenter, prospective, non-randomized, investigational study
Intervention
Transfemoral inplantation of the SJM Portico Transcatheter Aorta Valve.
Study burden and risks
Although conformance to all relevant production standards minimizes the
probability of migration, tissue tears, or undesirable leaflet functional
characteristics, they can potentially still occur. Complications associated
with the implantation of TAVI aortic valves are listed below. Nevertheless,
the benefit of using a TAVI device in high-risk and/or inoperable patients
outweighs the residual risk of these. The inoperable patient population is at
increased risk of death despite maximal medical therapy. In clinical practice,
at least 30% of the high risk patient population with severe aortic stenosis do
not undergo surgery, so a Portico Transcatheter Heart Valve provides a less
invasive treatment, with similar outcomes to surgery. An additional advantage
of the Portico TAVI valve can be the option to reposition the valve in case of
suboptimal valve placement.
During the 4 follow up visits during the study the patients will have an
echocardiography and ECG at each visit. This is a time burden but does not give
an additional risk for the patients. During these 4 visits also blood will be
drawn, which gives a minor risk of bruises, or hematomas at the puncture site.
finally the patients will have to do a 6 minute walk test during the follow up
visits and fill out a quality of life questionnaire. This is also a time burden.
The following complications are associated with the use of TAVI valves:
• Access site complications (i.e. pain, bleeding, hematoma, infection,
pseudoaneurysm)
• Acute coronary obstruction
• Acute myocardial infarction
• Allergic reaction to antiplatelet agents or contrast medium
• Anaphylactic Shock / Toxic Reaction
• Annulus Rupture
• Anemia
• Aortic Dissection/Rupture
• Ascending aortic trauma
• Arrhythmia
• Atrio-ventricular node block
• Bleeding Event
• Cardiac Decompensation
• Complete Loss of Hemodynamics
• Heart Failure
• Contrast Reaction
• Conversion to Open Sternotomy
• Coronary Artery Obstruction (Calcium, Intraoperative)
• Dissection, Any Vessel
• Embolism (Air, Atherosclerotic, Calcific, Device Particulates, Device,
External Particulates, Thrombus)
• Emergent balloon valvuloplasty
• Emergent Percutaneous Coronary Intervention (PCI)
• Emergent Surgery (e.g. coronary artery bypass, valve replacement)
• Endocarditis / Infection / Sepsis - Valve Related
• Hematoma
• Hemorrhage
• Hemodynamic Compromise
• Hemolysis
• Hemolytic Anemia
• Hypotension or hypertension
• Iliac Dissection
• Iliac Rupture
• Immunological Reaction
• Infection
• Leakage, Regurgitation
• Left Ventricle Failure
• Mitral Valve Insufficiency
• Multi-organ Failure
• Myocardial Infarction
• Myocardial Ischemia
• Nonstructural Dysfunction
• Pannus
• Paravalvular Leak (PV)
• Perforation, Myocardium or Any Vessel
• Post-Procedure Bleeding
• Pseudoaneurysm, Access Site
• Pulmonary Embolism
• Reintervention
• Renal Failure
• Rupture of Left Ventricle
• Sepsis
• Septal Rupture
• Stenosis- High Gradient
• Stroke or other neurological event
• Structural Valve Deterioration
• Tamponade
• Thrombus
• Valve Thrombosis
• Valve migration
• Ventricular Failure, Acute
• Vessel dissection or spasm
Adverse Device Effects (specific to device)
• Accessory Device Failure
• Damage to Implant
• Dehiscence of Device
• Malposition at Valve Deployment
• Mitral Valve Chordae Rupture/Damage
• Mitral Valve Leaflet Erosion
• Mitral Valve Leaflet Interference/Insufficiency
• Patient Prosthesis Mismatch
• Trauma to Adjacent Structures
• Trauma to Introduction Site
• Valve Migration
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Listed location countries
Age
Inclusion criteria
1. Subject has given written study Informed Consent for participation prior to
procedure.
2. Subject is >= 18 years of age or legal age in host country.
3. Subject*s aortic annulus diameter meets the range indicated in the
Instructions for Use as measured by CT conducted within the past 120
days, or echocardiogram (TEE 3D recommended) if medically
contraindicated to CT.
4. Subject has senile degenerative aortic stenosis with echocardiography
derived mean gradient >40mmHg or jet velocity greater than 4.0 m/s or an
initial valve area of <1.0 cm2 (or aortic valve area index <= 0.6 cm2/m2).
(Baseline measurement taken by echo within 30 days of procedure).
5. Subject has symptomatic aortic stenosis as demonstrated by NYHA
Functional Classification of II or greater.
6. Subject is deemed high operable risk and suitable for TAVI per the
medical opinion of the Subject Selection Committee (See Section 3.1 for
the definition of the Subject Selection Committee).
7. Subject*s predicted operative mortality or serious, irreversible morbidity
risk is <50% at 30 days.
8. In the opinion of the Subject Selection Committee and based upon
angiographic measurements, the subject has suitable peripheral vessels
and aorta to allow for access of the delivery system.
9. Subject has structurally normal cardiac anatomy.
10. Subject is willing and able to comply with all required follow-up
evaluations.
Exclusion criteria
1. Subject has a history of a cerebral vascular accident (CVA) or transient
ischemic attack (TIA) within the past 6 months (<=180 days) of the index
procedure.
2. Subject has carotid artery disease requiring intervention.
3. Subject has evidence of a myocardial infarction (MI) (defined as: ST
Segment elevation as evidenced on 12 Lead ECG) within the past 6
months (<=180 days) of the index procedure.
4. Subject has hypertrophic cardiomyopathy.
5. Subject has a native aortic valve that is congenitally unicuspid, bicuspid,
quadricuspid or non-calcified as seen by echocardiography.
6. Subject has mitral or tricuspid valvular regurgitation (> grade III) or
moderate to severe mitral stenosis.
7. Subject has aortic root angulation >70 degrees (horizontal aorta).
8. Subject has a pre-existing prosthetic valve or prosthetic ring in any
position.
9. Subject refuses blood transfusion or surgical valve replacement.
10. Subject has resting left ventricular ejection fraction (LVEF) < 20%.
11. The subject has documented, untreated symptomatic coronary artery
disease (CAD) requiring revascularization.
12. Subject has severe basal septal hypertrophy.
13. Subject has had a percutaneous interventional or other invasive cardiac or
peripheral procedure <= 14 days of the index procedure.
14. Subject has a history of or has active endocarditis.
15. Subject has echocardiographic evidence of intracardiac mass, thrombus,
or vegetation.
16. Subject has hemodynamic instability (requiring inotropic support or
mechanical heart assistance).
17. Subject is in acute pulmonary edema or requiring intravenous diuretic
therapy to stabilize heart failure.
18. Subject with significant pulmonary disease as determined and
documented by the Investigator.
19. Subject has significant chronic steroid use as determined and documented
by the Investigator.
20. Subject has a known hypersensitivity or contraindication to anticoagulant
or antiplatelet medication.
21. Subject has renal insufficiency as evidenced by a serum creatinine > 3.0
mg/dL (265.5 µmol/L) or end-stage renal disease requiring chronic
dialysis.
22. Subject has morbid obesity defined as BMI >= 40.
23. Subject*s iliac arteries have severe calcification, tortuosity (>two 90 degree
bends), diameter <6mm, or subject has had an aorto-femoral bypass.
24. Subject has ongoing infection or sepsis.
25. Subject has blood dyscrasias (leukopenia, acute anemia,
thrombocytopenia, bleeding diathesis, or coagulopathy).
26. Subject has a current autoimmune disease that, in the opinion of the
Principal Investigator precludes the subject from study participation.
27. Subject has significant aortic disease, including:
o aortic abdominal aneurysm (AAA) >= 4cm
o thoracic aneurysm (defined as a maximal luminal diameter of 5 cm
or greater)
o marked tortuosity
o significant aortic arch atheroma or narrowing of the abdominal or
thoracic aorta
o severe tortuosity of the thoracic aorta.
28. Subject has a pre-existing endovascular stent graft in the supra- or
infrarenal aorta or pre-existing stent grafts in the ileo-femoral arteries.
29. Subject has an active peptic ulcer or has had gastrointestinal (GI) bleeding
within the past 90 days prior to the index procedure.
30. Subject is currently participating in another investigational drug or device
study.
31. Subject has/had emergency surgery for any reason within 30 days of the
index procedure.
32. Subject has a life expectancy < 12 months.
33. Subject has other medical, social or psychological conditions that, in the
opinion of the Subject Selection Committee, preclude the subject from
study participation.
34. Subject is suffering from dementia or is admitted to a chronic care facility
which would fundamentally complicate rehabilitation from the procedure or
compliance with follow-up visits.
35. Subject has a known allergy to contrast media, nitinol alloys, porcine
tissue, or bovine tissue.
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 | NL47589.099.14 |