To evaluate the safety and performance of the HLT System in patients with symptomatic heart disease due to severe aortic stenosis who are judged by a Heart Team to be at Intermediate or High Risk for aortic valve replacement surgery
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary safety endpoint is all-cause mortality at 30 days
Secondary outcome
Secondary Performance Endpoint 1: Procedural Device Performance
The primary performance endpoint is Device Success defined as:
• Absence of procedural mortality AND
• Correct positioning of a single Valve into the proper anatomical location AND
• Intended performance of the Valve (no prosthesis-patient mismatch and mean
aortic valve gradient < 20 mmHg or peak aortic valve velocity < 3 m/sec, AND no
moderate or severe aortic valve regurgitation)
Secondary Performance Endpoint 2: Post-procedural Valve Performance
Valve performance will be evaluated by an independent Echo Core Laboratory at
pre-discharge, 30 Days, 6, 12, 24, 36, 48 and 60 months for the following
hemodynamic parameters:
• Aortic valve area (AVA)
• Aortic valve regurgitation (AR)
• Aortic valve gradient (Mean and Peak)
Secondary Safety Endpoint 3: Adverse Events
• All adverse events through the one (1) year follow up period
• All Serious Adverse Events through the five (5) year follow up period
• Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) at 30 Days, 6
months, 12 months and annually through five (5) years
Background summary
Aortic valve stenosis is a common condition that is characterized by a reduced
orifice opening and increased resistance to blood being pumped out of the left
ventricle to the systemic circulation. It can result from rheumatic fever,
congenital abnormalities (e.g. bicuspid valve) or from degenerative disease
(senile, calcific) with progressive calcification. All three (3) causes result
in fibrosis of the valve, thickening and fusion of the leaflets and restriction
of valve opening. When stenosis becomes severe, it results in symptoms of
angina, syncope and heart failure. In these patients, the mean time to death
from onset of symptoms is five, three and two years, respectively (Banbury MK,
2002 May:73(5)).
Since there is no effective medical treatment, the current reference treatment
for severe aortic stenosis is surgical aortic valve replacement (SAVR), which
offers symptomatic relief and improved long-term survival in most patients.
Standard SAVR includes using either a mechanical valve, or a bioprosthetic
valve, made from animal tissue. Mechanical valves may have an infinite life,
but the increased risk of stroke requires the concomitant use of
anticoagulants, which increases the risk of bleeding. Tissue valves do not
require the use of anticoagulants but are less durable than mechanical valves.
Furthermore, SAVR requires a sternotomy and cardiopulmonary bypass and
therefore can be associated with significant risk and morbidity (Lung B B. G.,
2003 (24)). Surgical risk is higher in patients with left ventricular failure,
concomitant coronary artery disease, chronic obstructive pulmonary disease
(COPD) and advanced age. In addition, results from the Euro Heart survey
suggest that up to 33% of patients with aortic stenosis were either not offered
surgery because of high risk or declined surgery because of patient preference
(Lung B e. a., 2005 Dec;26(24)).
see point 5.3 of the protocol
Study objective
To evaluate the safety and performance of the HLT System in patients with
symptomatic heart disease due to severe aortic stenosis who are judged by a
Heart Team to be at Intermediate or High Risk for aortic valve replacement
surgery
Study design
This is a prospective, non-randomized, single arm, multi-center CE Mark trial
Intervention
TAVR procedure
Study burden and risks
standard risks for TAVR and severe aortic valve stenosis
7351 Kirkwood Lane North, Suite 104
Maple Grove, MN 55369
US
7351 Kirkwood Lane North, Suite 104
Maple Grove, MN 55369
US
Listed location countries
Age
Inclusion criteria
1. Echocardiographic or hemodynamic based evidence of severe aortic stenosis
with one of the following:
a) Aortic valve area <= 1.0 cm2 or 0.6 cm2/m2
b) Mean aortic valve gradient >= 40 mmHg
c) Peak aortic valve velocity >= 4 m/sec
2. Symptom*s due to severe aortic stenosis resulting in one of the following:
a) NYHA Functional Classification of II or greater
b) Presence of angina
c) Presence of syncope, 3. Documented aortic valve annular size of >= 24 and <=
26 mm (associated perimeter range is 76-81mm or associated area range of
453-530 mm2) by the MSCT Core Lab assessment of pre-procedure imaging. ,
4. Patient is considered intermediate or high risk to undergo surgical aortic
valve replacement with one of the following:
a) Direct surgical risk STS-PROM score of >= 3% till 8%
b) great surgical risk STS-PROM score >=8%
C) Documented heart team agreement of risk for surgical aortic valve
replacement (SAVR) due to other factors not captured by risk-scores (i.e.
frailty or comorbidities)
5. Geographically available, willing to comply with follow up and able to
provide written informed consent
Exclusion criteria
1. 1. Congenital unicuspid or bicuspid aortic valve, or noncalcified aortic
valve; or valve eccentricity (calcific or otherwise) which could compromise
procedural success , 3. Patients with low flow/low gradient aortic stenosis
4. Patients with significant annular or LVOT calcification that could
compromise procedural success
5. Pre-existing prosthetic heart valve in any position, or prosthetic ring
7. Moderate to severe mitral stenosis
8. Myocardial infarction within the past 30 days*
10. Left Ventricular Ejection Fraction (LVEF) < 30%
22 Need for emergent surgery or intervention other than the investigational
procedure
23 Any therapeutic invasive cardiac procedure performed or planned to perform
within 30 days of the index procedure, except for PCI which is within 7 days of
the index procedure
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 | NCT03805711 |
| CCMO | NL69163.078.19 |