Demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is non-inferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low…
ID
Source
Brief title
Condition
- Other condition
- Cardiac valve disorders
Synonym
Health condition
Aortastenosis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
All-cause mortality or disabling stroke at 2 years
Secondary outcome
Safety
1. Composite of death, disabling stroke, life-threatening bleed, major vascular
complication, or AKI (II or III) at 30 days
2. New permanent pacemaker implantation at 30 days
3. Prosthetic valve endocarditis at one year
4. Prosthetic valve thrombosis at one year
5. All stroke (disabling and non-disabling) at one year
6. Life-threatening bleed at one year
7. Valve-related dysfunction requiring repeat procedure at one year
Effectiveness
1. Valve-related dysfunction (moderate or severe stenosis or regurgitation) at
one year
2. Quality of Life as assessed by Kansas City Cardiomyopathy (KCCQ) at one year
3. Repeat hospitalization for aortic valve disease at one year
Background summary
Over the past ten years, transcatheter aortic valve replacement (TAVR) has
emerged as a transformative
technology for the management of severe aortic stenosis. TAVR has become the
standard of care for
patients with aortic stenosis who are inoperable or at extreme risk for
surgical aortic valve replacement,
and is the preferred alternative for patients with severe aortic stenosis who
are at high risk for surgical
aortic valve replacement. Following Cribier*s first implantation in 2002, TAVR
has evolved to become a
standard procedure at specialized heart centers worldwide, and is now performed
with only moderate
sedation rather than general anesthesia in many patients.
TAVR was initially performed in patients at the highest risk for surgical
aortic valve replacement, but data
indicate that patients at intermediate risk are increasingly being treated with
TAVR.
In addition to the main study, subjects may volunteer in the LTI sub-study to
help determine the frequency (how often) leaflet thickening and reduced leaflet
motion are found in tissue valves after transcatheter or surgical aortic valve
replacement. Participation in this sub-study is optional.
Study objective
Demonstrate that the safety and effectiveness of the Medtronic TAVR system as
measured by rates of all-cause mortality or disabling stroke at two years is
non-inferior to SAVR in the treatment of severe aortic stenosis in subjects who
have a low predicted risk of operative mortality for SAVR
The LTI sub-study is being done to gather information on how often leaflet
thickening and reduced leaflet motion occur in tissue valves after
transcatheter or surgical aortic valve replacement.
Study design
Multi-center, international, prospective, randomized, interventional,
pre-market. Subjects will be randomized on 1:1 basis to either TAVR with the
Medtronic TAVR system or to SAVR.
The LTI sub-study will involve approximately 300 subjects at up to 100
hospitals worldwide who will be followed for one year after implant procedure
as part of the sub-study.
Intervention
Transcatheter Aorta Valve replacement (TAVR)
Surgical Aorta Valve Replacement (SAVR)
Study burden and risks
As with any TAVR or SAVR procedure, there are risks associated with
participation in this trial. However,
the risks to a patient for participation in this trial are not materially
different than those a patient would
incur if they underwent TAVR or SAVR outside of this trial,see protocol page
70-72
Endepolsdomein 5
Maastricht 6229 GW
NL
Endepolsdomein 5
Maastricht 6229 GW
NL
Listed location countries
Age
Inclusion criteria
Heart Team consensus patient has < 3% predicted risk of mortality at 30 days
for SAVR
* Severe aortic stenosis, defined as :
* Symptomatic aortic stenosis
Aortic valve area <= 1.0 cm2 (or aortic valve area index of <= 0.6 cm2/m2), OR
mean
gradient >= 40 mmHg, OR maximal aortic valve velocity >= 4.0 m/sec by
transthoracic echocardiography
* Asymptomatic aortic stenosis:
- Very severe aortic stenosis with an aortic valve area of <=1.0 cm2 (or aortic
valve area index of <=0.6 cm2/m2), AND maximal aortic velocity >= 5.0 m/sec,
or mean gradient >= 60 mmHg by transthoracic echocardiography, OR
- Aortic valve area of <=1.0 cm2 (or aortic valve area index of <=0.6 cm2/m2), AND
a mean gradient >= 40 mmHg, or maximal aortic valve velocity >= 4.0 m/sec by
transthoracic echocardiography, AND an exercise tolerance test that
demonstrates a limited exercise capacity, abnormal BP response, or
arrhythmia OR
- Aortic valve area of <= 1.0 cm2 (or aortic valve area index of <= 0.6 cm2/m2),
AND mean gradient >= 40 mmHg, or maximal aortic valve velocity >= 4.0 m/sec
by transthoracic echocardiography, AND a left ventricular ejection fraction <
50%.
* Indicated for SAVR with a bioprosthesis
Exclusion criteria
Bicuspid aortic valve identified by echocardiography, MDCT, or Magnetic
Resonance
Imaging
Significant ascending aortopathy
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 | NCT02701283 |
| CCMO | NL60501.100.17 |