To assess the safety, efficacy, and performance of the TriGuard HDH embolic deflection device in patients undergoing transcatheter aortic valve implantation (TAVI), in comparison with patients undergoing unprotected TAVI.
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The overall occurrence of the composite in-hospital procedural safety endpoint
will be reported by treatment arm using descriptive statistics (frequencies,
percentages, and two-sided exact 95% confidence intervals) in the Intention to
Treat (ITT) population of evaluable subjects (Roll-In patients are excluded).
No formal hypothesis testing will be performed. For safety endpoint events
occurring in the Intervention and Roll-In groups, relationship to the
investigational device/investigational procedure (as determined by an
independent Clinical Events Committee) will also be reported.
Thirty-four (34) evaluable subjects in each treatment arm are expected to be
sufficient to provide information regarding the safety, performance, and
efficacy of the TriGuard HDH device relative to unprotected TAVI. An interim
analysis will be performed after 20 subjects have been enrolled in each
treatment arm (40 evaluable subjects total). The study will continue to enroll
until 4±2 day postprocedural DW MRI data is available for 34 subjects in each
treatment arm (68 evaluable subjects total). The sample size has been increased
to 86 evaluable subjects to account for an expected 20% loss to DW MRI
follow-up.
As a secondary analysis, the primary endpoint will also be reported in the Per
Protocol (PP) population of evaluable subjects (Roll-In patients are excluded).
The PP population is defined as all subjects in whom no major protocol
deviations (i.e., failure to obtain informed consent, failure to adhere to
study eligibility criteria, or failure to use the TriGuard HDH in accordance
with the Instructions for Use) are recorded.
Secondary outcome
All secondary endpoints will be reported by treatment group in the Intention To
Treat (ITT) Population of evaluable subjects (Roll-In patients are excluded)
using descriptive statistics. No formal hypothesis testing will be performed.
Statistics for continuous variables will include mean, median, standard
deviation, minimum, maximum, and sample size for each treatment group, and
two-sided exact 95% confidence intervals. Binary variables will be summarized
using frequencies, percentages, and two-sided exact 95% confidence intervals.
For time-to-event data, Kaplan-Meier estimates at the indicated time points
will be displayed along with two-sided exact 95% confidence intervals.
As additional analysis, all secondary endpoints will be evaluated in the PP
population of evaluable subjects.
Background summary
The incidence of stroke and subclinical cerebral ischemic lesions, and their
association with postprocedural neurological deficits, indicate that methods to
prevent or reduce cerebral embolization are vital to optimizing TAVI procedures
and improving the outcomes of patients with severe aortic stenosis. The first
generation TriGuard device has been demonstrated to safety reduce the total
cerebral ischemic lesion volume after TAVI compared with historical controls.
This prospective, randomized trial will provide more comprehensive evaluation
of the safety, efficacy, and performance of the TriGuard HDH device compared
with a concurrent active control of unprotected TAVI. By employing standardized
imaging acquisition and analysis parameters and detailed neurocognitive
testing, the DEFLECT III trial will also advance the understanding of
subclinical neurological events and their relationship with neurocognitive
function in patients undergoing cardiovascular interventions.
Study objective
To assess the safety, efficacy, and performance of the TriGuard HDH embolic
deflection device in patients undergoing transcatheter aortic valve
implantation (TAVI), in comparison with patients undergoing unprotected TAVI.
Study design
This prospective, randomized, multicenter, non-powered, safety, efficacy, and
performance trial will enroll up to 86 evaluable subjects and up to 15 roll-in
subjects at up to 15 investigational sites in Europe and Israel.
Subjects with indications for TAVI and who meet study eligibility criteria will
be randomized 1:1 to one of two treatment arms:
• Intervention - TAVI with the TriGuard HDH embolic deflection device
• Control - standard unprotected TAVI
Prior to the first evaluable subject, each investigational site without prior
experience with the TriGuard device (minimum of 3 prior cases) will enroll up
to 1 roll-in subject, all of whom will undergo TAVI with the TriGuard HDH
device. Investigational sites with >=3 prior TriGuard cases may choose to enroll
1 roll-in subject at the discretion of the site principal investigator.
All subjects will be followed clinically in-hospital and at 30 days, undergo
diffusion-weighted MR imaging at 4±2 days and at 30±7 days post-procedure, and
undergo neuropsychological testing pre- and post-procedure and at 30 (±7) days.
Intervention
.
Study burden and risks
The known risks for TAVI are applicable, besides the potential of local vessel
damage due to manipulation of the device in
the aortic arch and manufacturing problems of the device which may lead to
unforeseen complications. The benefit would
be the prevention of cerebral embolsim during the TAVI procedure.
Caesarea Business Park, POB 3170
Caesarea 3088900
IL
Caesarea Business Park, POB 3170
Caesarea 3088900
IL
Listed location countries
Age
Inclusion criteria
1. The patient is a male or non-pregnant female >=18 years of age
2. Patient meets indications for TAVI
3. The patient is willing to comply with protocol-specified follow-up evaluations
Exclusion criteria
1. Patients undergoing TAVI via the trans-axillary, trans-subclavian, or trans-aortic route
2. Patients undergoing TAVI via the transapical approach due to friable or mobile atherosclerotic plaque in the aortic arch
3. 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
4. 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, in whom CK and CK-MB have not returned to within normal limits at the time of procedure.
5. Patients who are currently experiencing clinical symptoms consistent with new-onset AMI, such as nitrate-unresponsive prolonged chest pain
6. Patients with a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, or who will refuse transfusion
7. Patients with known other mental or physical 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
8. Patients with severe allergy to heparin or known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel, nitinol, stainless steel alloy, and/or contrast sensitivity that cannot be adequately pre-medicated
9. Patients with a history of a stroke or transient ischemic attack (TIA) within the prior 6 months
10. Patients with an active peptic ulcer or history of upper gastrointestinal (GI) bleeding within the prior 6 months
11. Patients with renal failure (estimated Glomerular Filtration Rate [eGFR] <30 mL/min, calculated from serum creatinine by the Cockcroft-Gault formula)
12. Patients with hepatic failure (Child-Pugh class C)
13. Patients with hypercoagulable states that cannot be corrected by additional periprocedural heparin
14. Patients presenting with cardiogenic shock or severe hypotension (systolic blood pressure <90 mm Hg) at the time of the index procedure
15. Patients with severe peripheral arterial disease that precludes delivery sheath vascular access
16. Patients with a heavily calcified or severely atheromatous aortic arch
17. Patients with an innominate artery ostium diameter <11 mm
18. Patients with a transverse aortic diameter >40 mm
19. Patients with anatomic irregularities of the aortic arch or innominate artery that could prevent positioning and stability of the device
20. Patients with contraindication to cerebral MRI
21. Patients who have a planned treatment with any other investigational device or procedure during the study period
22. Patients planned to undergo any other cardiac surgical or interventional procedure (e.g., concurrent coronary revascularization) during the TAVI procedure or within two (2) weeks prior to the TAVI procedure or after the (optional) baseline DW MRI
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 | NL48386.041.14 |