brain infarction stroke
Conditions
Interventions
None listed
Sponsors
Keystone Heart
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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] 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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed