The purpose of this study is to demonstrate the safety and performance of the Leaflex* when used for aortic valve repair in patients with symptomatic severe aortic stenosis. The main performance objective is to demonstrate an acute increase in…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary performance endpoint - change in AVA measured by echocardiography
before treatment with the Leaflex* (within 7 days prior to index procedure) and
after treatment with the Leaflex* (within 3 days post index procedure).
Main safety endpoints:
* Composite rates of all-cause mortality and stroke (according to VARC-2
definitions48) through 30 days post the procedure.
* Worsening of aortic regurgitation (AR) by >1 grade assessed by
echocardiography at 30 days post the procedure compared to before treatment
with the Leaflex* (within 7 days prior to treatment) and to after treatment
with the Leaflex* (within three days post treatment).
* Assessment of all adverse events from enrollment up to 12 months post
procedure.
Secondary outcome
Secondary performance endpoints:
* Post Leaflex* AVA, AVAi and peak and mean pressure gradients measured by
echocardiography after treatment with the Leaflex* (within 3 days post index
procedure).
* Intra-procedural change of invasive transvalvular pressure gradients,
computed as difference in mean and in peak-to-peak pressure gradients across
the aortic valve immediately prior to treatment with the Leaflex* and
immediately following treatment with the Leaflex*.
* Change in AVA and in peak and mean pressure gradients, measured by
echocardiography, from before treatment with the Leaflex* (within 7 days prior
to index procedure) and from after treatment with the Leaflex* (within 3 days
post index procedure) to 1, 3, 6, 9 and 12 months post procedure.
* Change in 6MWT from baseline to 1, 6 and 12 months post procedure.
* Change in quality of life from baseline to 1, 6 and 12 months post procedure.
Note: AVA and AVAi shall be computed by echocardiography as Effective Orifice
Area (EOA) and Effective Orifice Area Index (EOAi).
Background summary
Aortic valve stenosis (the blood flow from the heart to the body is reduced
because the passage through the aortic valve is reduced) causes symptoms such
as shortness of breath.
Standard treatment for aortic stenosis is surgical valve repair or
Transcatheter Aortic Valve Implantation (TAVI). However there remains a
population of patients that require some treatment of their aortic stenosis but
are not candidates for surgical repair or TAVI due to either co-morbidities,
age or short life expectancy. Currently, these patients are left with the
option of Balloon Aortic Valvuloplasty (BAV) or standard medical treatment.
The use of BAV is limited, mainly due to the very short durability of its
therapeutic effect: early recoil or restenosis which occur with within 6*12
months in most patients, and mid- and long-term outcomes which are similar to
the natural history of aortic stenosis.
The Leaflex* is a 16Fr catheter, introduced trans-femorally, designed to create
scoring lines on the aortic surface of the aortic valve leaflets and score the
calcific deposits within the leaflets that restrict leaflet motion and cause
the clinical symptoms of aortic stenosis. The Leaflex* treatment is intended to
increase leaflet pliability and mobility, and consequently increase the aortic
valve area.
Study objective
The purpose of this study is to demonstrate the safety and performance of the
Leaflex* when used for aortic valve repair in patients with symptomatic severe
aortic stenosis. The main performance objective is to demonstrate an acute
increase in aortic valve area (AVA).
Study design
Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label,
interventional Clinical Study
Intervention
all patients undergo a trans-femoral catheter treatment of the aortic heart
valve.
Study burden and risks
The primary risks and discomforts that may be associated with the use of the
Leaflex are expected to be similar to complications associated with other
trans-catheter aortic valve interventions. The blood examination before the
Leaflex procedure is standard prior to any trans-catheter aortic valve
interventions.
The burden and risk associated with the screening procedure is similar to the
procedures performed prior to TAVI and is limited to:
* Echo (TTE) - unless a TTE performed within 60 days of screening is available
* Cardiac gated CT scan with and without contrast - unless a CT scan performed
within 6 months of screening is available.
The burden and risks associated with study specific examinations during
follow-up includes examinations that patients with aortic stenosis would
typically undergo, althought the frequency of the follow-up visits (standard
after 1 and 12 months) is increased (study 1, 3, 6, 9, and 12 months) and
includes:
Echography heart (TTE)
Electrocardiography (ECG)
Physical examination
Medical evaluation
Neurological examination (in case of known/suspected TIA/CVA)
*6 minute walk* * test en 2 quality of life questionnaires (baseline, 1, 6 ,12
months)
*5-meter walk*-test (baseline)
Modified Physical Performance Test (PPT) (baseline)
Fikes Street 5
Rehovot 7632805
IL
Fikes Street 5
Rehovot 7632805
IL
Listed location countries
Age
Inclusion criteria
1. Male and female age >18 years.
2. Patient with severe aortic stenosis.
3. Senile degenerative severe aortic valve stenosis with echocardiography
derived criteria: mean gradient > 40 mmHg OR jet velocity > 4.0 m/s OR AVA *
1.0 cm2 OR AVA index (AVAi) * 0.6 cm2/m2.
4. NYHA Functional Class * 2 OR exercise test that demonstrates a limited
exercise capacity, abnormal BP response, or arrhythmia.
5. Not recommended by the heart team for immediate treatment with surgical or
transcatheter aortic valve replacement.
Exclusion criteria
1. Aortic valve is unicuspid, bicuspid, or non-calcified.
2. Severe aortic regurgitation (>2+).
3. An exceptional aortic valve leaflet Calcium morphology, as determined by the
CT Core Lab.
4. Pre-existing mechanical or bioprosthetic aortic or mitral valve.
5. Iliofemoral vessel characteristics that would preclude safe placement of the
introducer sheath.
6. Coronary disease that, in the opinion of the heart team, should be treated;
or treatment of coronary disease * 1 month prior to index procedure.
7. Aortic balloon valvuloplasty * 3 months prior to index procedure.
8. CVA or TIA * 12 months prior to index procedure.
9. History of a myocardial infarction (MI) * 6 weeks prior to index procedure.
10. Previous or current bacterial endocarditis.
11. Ongoing severe infection or sepsis.
12. Life expectancy * 12 months post index procedure due to morbidity other
than aortic valve related.
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 | NL73895.078.20 |