To demonstrate the safety and performance of the SMT Embolic Deflection Device in patients undergoing Transcatheter Aortic Valve Replacement (TAVR).
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary performance endpoint -
Device performance Device performance is defined as the ability to perform all
of the following functions in the absence of adjudicated device malfunction:
- Access the aortic arch with the delivery catheter;
- Deploy the SMT Embolic Deflection Device from the delivery catheter into the
aortic arch;
- Position the SMT Embolic Deflection Device to cover all 3 vessels (verified
by angiography) without obstruction of cerebral/carotid vessel blood flow and
without interference with the TAVR procedure (defined as ability to
successfully advance, deploy, and retrieve the TAVR device without hindrance by
or displacement of the SMT device);
- Retrieve the SMT device and remove the intact delivery system.
Primary safety endpoint
In-hospital device-related safety Incidence of investigational device- and
investigational procedure-related serious adverse events in a composite
in-hospital hierarchical safety endpoint. All events will be adjudicated for
relationship to the investigational device or investigational procedure by an
independent clinical events committee:
- Cardiovascular mortality;
- Major stroke;
- Life-threatening (or disabling) bleeding;
- Distal embolization (noncerebral) from a vascular source requiring surgery or
resulting in amputation or irreversible end-organ damage ;
- Major vascular or access-related complications ;
- Need for acute cardiovascular surgery.
Secondary outcome
Secondary Endpoints
1. Procedure success: In-hospital procedure success, defined as successful
device performance without the occurrence of the primary composite safety
endpoint of in-hospital device-related serious adverse events.
2. Efficacy Endpoint (powered endpoint): Presence of new embolic lesions
detected by diffusion-weighted MRI of the brain from pre-procedure to 4+2 days
(range 2-6 days) post-procedure.
3. Number and volume of new embolic lesions detected by diffusion-weighted MRI
of the brain from pre-procedure to 4+2 days (range 2-6 days) post-procedure.
4. Number of emboli detected on procedural transcranial Doppler ultrasound.
5. Device deployment time: Time elapsed between insertion of the SMT device
into the delivery sheath and successful deployment of the SMT device in the
aortic arch.
6. Total procedural time: Time elapsed between first arterial access and
removal of the last device/guide from the access or delivery sheath.
Secondary Safety Endpoints
1. Device-related safety in hospital (component) and at 30 days (component and
hierarchical composite). All events will be evaluated for relationship to the
investigational device or investigational procedure by an independent clinical
events committee:
- Cardiovascular mortality;
- Major stroke ;
- Life-threatening (or disabling) bleeding ;
- Distal embolization (noncerebral) from a vascular source requiring surgery or
resulting in amputation or irreversible end-organ damage ;
- Major vascular or access-related complications ;
- Need for acute cardiovascular surgery.
2. Procedure safety: Major Adverse Cardiac and Cerebrovascular Events (MACCE)
in hospital and at 30 days. MACCE is defined as the hierarchical composite of
- All cause mortality;
- Major stroke;
- Life-threatening (or disabling) bleeding ;
- Acute kidney injury - Stage 3 (including renal replacement therapy) ;
- Peri-procedural MI;
- Major vascular complication;
- Repeat procedure for valve-related dysfunction.
3. All cause and cardiovascular mortality in hospital and at 30 days.
4. Stroke and TIA in hospital and at 30 days.
5. Myocardial infarction (MI): Peri-procedural (<72 hours after index
procedure) and spontaneous (>72 hours after index procedure) Q-wave and
non-Q-wave MI, cumulative and individual in hospital and at 30 days.
6. Major Vascular Complications (VARC defined)
- Any thoracic aortic dissection;
- Access site or access-related vascular injury (dissection, stenosis,
perforation, rupture, arterio-venous fistula, pseudoaneurysm, hematoma,
irreversible nerve injury, or compartment syndrome) leading to either death,
need for significant blood transfusions (>=4 U), unplanned percutaneous or
surgical intervention, or irreversible end-organ damage (e.g., hypogastric
artery occlusion causing visceral ischemia or spinal artery injury causing
neurological impairment);
- Distal embolization (noncerebral) from a vascular source requiring surgery or
resulting in amputation or irreversible end-organ damage.
7. Minor vascular complications (VARC defined)
- Access site or access-related vascular injury (dissection, stenosis,
perforation, rupture, arteriovenous fistula or pseudoaneurysm requiring
compression or thrombin injection therapy, or hematomas requiring transfusion
of >=2 but <4 U) not requiring unplanned percutaneous or surgical intervention
and not resulting in irreversible end-organ damage;
- Distal embolization treated with embolectomy and/or thrombectomy and not
resulting in amputation or irreversible end-organ damage ;
- Failure of percutaneous access site closure resulting in interventional
(e.g., stent-graft) or surgical correction and not associated with death, need
for significant blood transfusions (>=4 U), or irreversible end-organ damage 8.
Acute Kidney Injury (VARC Defined) ;
- Change in serum creatinine up to 72 hours compared with baseline, or need for
renal replacement therapy.
Background summary
The TAVR procedure is used to treat a disease of the aortic valve called aortic
stenosis. The aortic valve lets oxygen-containing blood be pumped out of the
heart to the body. In patients with aortic stenosis, the valve becomes
thickened, stiff, and abnormally narrow. This makes the heart have to work
harder to pump the same amount of blood with each beat. One of the risks of the
TAVR procedure is that an abnormal particle (called an embolism) could break
off from inside the arteries and travel to the brain. The embolism could be
made of clumps of blood (clots), part of your body tissue, or part of a medical
device. If the embolism is carried through the blood to the brain, it could
cause a stroke (rapidly developing loss of brain function(s) due to disturbance
in the blood supply) or other neurological (brain) problems. For patients
undergoing TAVR, the SMT Embolic Deflection Device has been developed to
prevent an embolism from going to the brain and causing a stroke or other brain
damage. The medical device is investigational and is not yet approved for
commercial use. This study is aiming to determine the safety and performance of
the SMT Embolic Deflection Device in preventing an embolism going to the brain.
Study objective
To demonstrate the safety and performance of the SMT Embolic Deflection Device
in patients undergoing Transcatheter Aortic Valve Replacement (TAVR).
Study design
Prospective, multi-center, single arm study enrolling a minimum of 36 up to a
maximum of 60 patients at up to ten (10) investigational sites in the EU and
Canada. Patients meeting eligibility criteria for TAVR will be enrolled to
receive the SMT Embolic Deflection Device throughout the duration of the TAVR
procedure.
Intervention
During the TAVI procedure, the doctor will take some additional steps related
to the study device. At the start of the procedure, the doctor will make a
small incision or puncture in the skin of the upper thigh near the groin on the
opposite side of the body from the incision used to implant the new valve. A
long, thin flexible tube will be threaded through the bloodstream to insert the
study device. The doctor will use x-rays and an injected dye to make sure that
the study device is in the right place. This procedure will take an additional
3 to 4 minutes. The amount of additional x-rays used during placement of the
study device is small compared to the total amount of x-rays used during a
standard TAVR procedure. Once the study device is in place, the TAVI procedure
will be performed as normal. When the procedure is complete, the study device
will be removed through the same tube that was used to put it into the body.
Study burden and risks
As with any medical treatment, there are potential risks and benefits.
Potential risks associated to the aprticipation in this study include risks
related to the TAVR procedure, risks related to the study device, and risks
related to the tests performed specifically for the study.
Risks that may be associated with the participation in this study include, but
may not be limited to, the following
Risks Associated with the SMT Embolic Deflection Device
- Failure to completely block blood clots or material released during the
procedure from reaching the brain, which could require additional treatment or
surgery;
- Damage to the blood vessels leading to the heart or neck, especially if
excessive force is placed on the vessel, which could require urgent surgery or
cause other complications including death ;
- Failure or breakage of the device, which may not be possible to remove
without surgery ;
- Formation of blood clots on the study device or delivery system, which could
travel through the bloodstream and cause problems in another part of your body,
including the brain (which could cause a stroke), kidneys, intestines, or legs ;
- Allergic reaction (unfavorable reaction by the body) to the metal that the
study device is made out of ;
- A mottled skin pattern or a lace-like purplish discoloration of the lower
extremities, caused by swelling of medium-sized veins (vessels that carry blood
towards the heart) ;
The use of the SMT device may also be associated with other risks, which are
unknown at this time.
Risks Associated with IV Placement, Blood Tests, or Device Delivery System
Placement for the Study Device
Although intravenous (IV) line placement, blood tests, and catheter placement
are standard for any patient undergoing a TAVR procedure, the following risks
or complications may be associated with any procedure that requires a puncture
or opening of the skin:
- Pain;
- Bruising, bleeding or hematoma (blood accumulation under the skin around the
skin puncture site) ;
- Damage to blood vessels at the catheter insertion site (in the groin), or the
vessels leading to and from the heart which may require medical or surgical
treatment ;
- Damage to the nerves near the blood vessel that the catheter is put into ;
- Squeezing of nerves and muscles in a closed space (compartment syndrome) that
could cause nerve or muscle damage .
Risks Associated with the MRI Procedure
The patient may be given an injected dye to enhance the pictures that are being
taken. This could cause:
- Acute kidney injury or failure of the kidneys to work correctly;
- Allergic reaction (unfavorable reaction by the body) that can cause hives,
burning, and/or itching, and which may require medication to control ;
- Some people feel nervous (claustrophobic) while in the space that houses the
MRI magnet. The patient may be given medication to help him/ her to relax.
Risks Associated with CT scan
- Acute kidney injury or failure of the kidney to work correctly,
- Allergic reaction (unfavorable reaction by the body) that can cause hives,
burning, and/or itching, and which may require medication to control,
- The risks associated with ionizing radiation are covered below.
Ionising Radiation Exposure
The CT scan which is performed as part of the routine screening prior to
performing a TAVR procedure (whether or not the patient is participating in the
study) involves exposure to radiation. The long term risk of cancer from
low-level radiation doses typically received in this type of medical imaging is
uncertain. Recent report of the biologic effects of ionizing radiation from the
National Academies estimates that a single CT scan of the type used to screen
patients undergoing TAVR procedures would be expected to be associated with one
additional lifetime cancer case out of 667 individuals exposed.
The amount of X-ray radiation to which the patient is exposed during
fluoroscopic imaging should not significantly increase the risk of developing
associated illness, such as cancer. At most, the amount of radiation is
equivalent to around 7* years natural radiation which we all receive from the
environment. In addition to the normal chance of developing cancer in a
lifetime, taking part in this study could add to this by approximately 1 in
1550.
Other Risks and Discomforts That May Occur
There are potential risks associated with the TAVR procedure, with the tests
used to look at the blood vessels and heart before the procedure (CT scan), and
with the x-ray imaging (angiography) used to steer the catheter through the
blood vessels during the procedure. These risks are similar to those the
patient would be exposed to if he/ she was having a TAVR procedure outside this
study, without the use of the study device.
Other problems with the device may occur that are not known yet. Sometimes we
get new information about the treatment being studied. If this happens, the
research doctor will tell the patients and discuss whether they should continue
in the study. If this happens, the research doctor may consider withdrawing the
patients from the study. He/she will explain the reasons and arrange for the
patients' care to continue. If the study is stopped for any other reason, we
will tell the patients and arrange your continuing care.
The direct benefits of participating in the study are not known at this time.
The patients may benefit if the device is proven to be safe and effective at
preventing blood clots or other material breaking lose during the procedure may
be less likely to reach the brain, potentially avoiding a stroke or other
neurological problems.
The purpose of this study is to determine if the SMT Embolic Deflection Device
offers this benefit. The knowledge gained from this study will be valuable to
researchers and doctors in the treatment of future patients who have aortic
stenosis that may be treated by TAVR.
Galgaley Haplada St 20, POB 12240
Herzliya 46227
IL
Galgaley Haplada St 20, POB 12240
Herzliya 46227
IL
Listed location countries
Age
Inclusion criteria
1.1 The patient must be >= 18 years of age.
1.2 The patient meets indications for TAVR procedure.
1.3 The patient is willing to comply with specified follow-up evaluations.
1.4 The patient, or legally authorized representative, has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate Medical Ethics Committee (EC) or Institutional Review Board (IRB).
Exclusion criteria
2.1 Patients undergoing TAVR via the trans-axillary, subclavian or direct aortic route.
2.2 Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to index procedure per site standard test.
2.3 Patients with known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure (according to definition) or AMI > 72 hours preceding the index procedure and CK and CK-MB have not returned to normal limits at the time of procedure
2.4 Patients who are currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain.
2.5 Patients with impaired renal function (estimated Glomerular Filtration Rate [eGFR] <30, calculated from serum creatinine by the Cockcroft-Gault formula).
2.6 Patients with a platelet count <100.000 cells/mm³ or >700.000 cells/mm³ or a WBC <3000 cells/mm³ within 7 days prior to index procedure.
2.7 Patients with a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, or will refuse transfusion.
2.8 Patients who have received any organ transplant or are on a waiting list for any organ transplant.
2.9 Patients with known other medical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation or is associated with a life expectancy of less than one year.
2.10 Patients with a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, nitinol, stainless steel alloy, and/or contrast sensitivity that cannot be adequately pre-medicated.
2.11 Patients with a history of a stroke or transient ischemic attack (TIA) within the prior 6 months.
2.12 Patients with an active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months.
2.13 Patients presenting with cardiogenic shock.
2.14 Patients with severe peripheral arterial disease that precludes 9Fr sheath vascular access.
2.15 Patients with documented friable or mobile atherosclerotic plaque in the aortic arch.
2.16 Patients with contraindication to cerebral MRI.
2.17 Patients who have a planned treatment with any other investigational device or procedure during the study period.
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 | NCT01448421 |
| CCMO | NL38963.100.11 |