N/A
N=383
Neuroprotection in Patients Undergoing Aortic Valve Replacement
Aortic Stenosis · Brain Infarction · Cerebrovascular Accident · Stroke
Bottom Line
View on ClinicalTrials.gov: NCT02389894 ↗Enrolled (actual)
383
Serious AEs
46.7%
Results posted
Apr 2019
Primary outcome: Primary: Percentage of Participants With Freedom From Clinical or Radiographic Central Nervous System (CNS) Infarction — 74.4; 68.0; 67.6 percentage of participants — p=0.22
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Embol-X Embolic Protection Device (Device); CardioGard Cannula (Device)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Freedom From Clinical or Radiographic Central Nervous System (CNS) Infarction |
74.4; 68.0; 67.6 | 0.22 |
| SECONDARY Number of Participants With a Composite Endpoint of Mortality, Clinical Stroke, and Acute Kidney Injury |
44; 25; 31 | 0.08 |
| SECONDARY Number of Patients With Clinically Apparent Stroke at 7 Days |
11; 6; 8 | — |
| SECONDARY Presence of Radiographic Infarcts |
83; 66; 76 | — |
| SECONDARY Total Infarct Volume |
74; 42; 35 | — |
| SECONDARY Decline in Overall Neurocognition |
28; 24; 31 | — |
| SECONDARY Decline in Neurocognitive Function in the Verbal Memory Domain at 90 Days |
31; 38; 35 | — |
| SECONDARY Decline in Neurocognitive Function in the Visual Memory Domain at 90 Days |
36; 25; 32 | — |
| SECONDARY Decline in Neurocognitive Function in the Executive Function Domain at 90 Day |
19; 25; 31 | — |
| SECONDARY Decline in Neurocognitive Function in the Visuospatial/Constructional Praxis Domain at 90 Days |
31; 28; 41 | — |
| SECONDARY Decline in Neurocognitive Function in the Auditory-Verbal Simple Attention Domain at 90 Days |
36; 28; 38 | — |
| SECONDARY Decline in Neurocognitive Function in the Visuomotor/Information Processing Speed Domain at 90 Days |
43; 30; 33 | — |
| SECONDARY Modified Rankin Scale >2 at 90 Days |
5; 7; 5 | — |
| SECONDARY Barthel Index <= 80 |
2; 2; 4 | — |
| SECONDARY Number of Participants With Confusion Assessment Method (CAM) Delirium Assessment at 7 Days |
10; 7; 19 | — |
| SECONDARY Mortality by 90 Days |
4; 5; 3 | — |
| SECONDARY Length of Stay for Index Hospitalization |
10.4; 9.8; 10.3 | — |
| SECONDARY Hospital Readmissions |
9.3; 8.4; 7.1 | — |
| SECONDARY Quality of Life - Physical Health Composite |
43.0; 44.9; 44.2 | — |
| SECONDARY Quality of Life - Mental Health Composite |
55.2; 55.4; 54.8 | — |
| SECONDARY Number of Participants With Emboli Captured |
115; 79; 0 | — |
Summary
To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement (AVR).
Eligibility Criteria
Inclusion Criteria
- Age ≥ 60 years
- Planned and scheduled surgical aortic valve replacement via a full or minimal-access sternotomy (using central aortic perfusion cannulae) for calcific aortic stenosis with a legally marketed valve
- No evidence of neurological impairment as defined by a NIHSS ≤1 and modified Rankin scale (mRS) ≤ 2 within 7 days prior to randomization
- Ability to provide informed consent and comply with the protocol
Exclusion Criteria
- Contraindication to legally marketed embolic protection devices (e.g. aneurysm of the ascending aorta, aortic trauma, porcelain aorta, known sensitivity to heparin)
- History of clinical stroke within 3 months prior to randomization
- Cardiac catheterization within 3 days of the planned aortic valve replacement
- Cerebral and or aortic arch arteriography or interventions within 3 days of the planned aortic valve replacement
- Active endocarditis at time of randomization
- Anticipated inability to tolerate or contraindication for MRI (e.g., known intolerance of MRI, permanent pacemaker at baseline or expected implantation of a permanent pacemaker)
- Any other concomitant aortic procedure such as root replacement
- Concomitant surgical procedures other than CABG, mitral annuloplasty, left atrial appendage (LAA) excision or exclusion, atrial septal defect (ASD) closure or patent foramen ovale (PFO) closure
- Clinical signs of cardiogenic shock or treatment with IV inotropic therapy prior to randomization
- Concurrent participation in an interventional (drug or device) trial
Data sourced from ClinicalTrials.gov (NCT02389894). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.