A Study To Evaluate Protection Devices For Reducing Ischemic Brain Injury In Patients Undergoing Aortic Valve Replacement
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-001432
NCT ID: NCT02389894
Sponsor Protocol Number: 16-001432
About this study
The purpose of this study is to evaluate the effectiveness and safety of protection devices against embolism, to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator |
Closed for enrollment |
|
More information
Publications
Publications are currently not available