Registry evaluating cerebral protection devices during TAVR procedures
Evaluation of Procedural Outcomes and Safety of Cerebral Embolic Protection Device for Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement in Routine Clinical Practice, A Multicenter, Prospective Observational Study
Asan Medical Center · NCT05217888
This study is testing whether using a special device during heart valve replacement surgery can help protect the brains of patients who are at higher risk for strokes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Asan Medical Center (other) |
| Locations | 11 sites (Bucheon and 10 other locations) |
| Trial ID | NCT05217888 on ClinicalTrials.gov |
What this trial studies
This registry aims to assess the procedural and safety outcomes of using cerebral protection devices during transfemoral transcatheter aortic valve replacement (TAVR) in real-world clinical settings. It will collect data from patients undergoing TAVR with the SENTINEL device and compare it to data from another registry using propensity score matching. The focus is on patients at higher risk for cerebrovascular events, ensuring a comprehensive evaluation of the device's effectiveness. The study will involve multiple clinical sites to gather diverse patient data.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 and older who are undergoing TAVR with the SENTINEL device and have a higher risk of cerebrovascular embolic events.
Not a fit: Patients with vascular issues preventing access for the SENTINEL device or those without significant risk factors for cerebrovascular events may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could enhance the safety and outcomes of TAVR procedures by better understanding the role of cerebral protection devices.
How similar studies have performed: While this registry approach is not novel, it builds on existing data from similar studies, suggesting potential for meaningful insights into the use of cerebral protection devices.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 19 and more * Undergoing TAVR with the use of SENTINEL embolic protection device * Higher risk of cerebrovascular embolic events (any of the followings) 1. Bicuspid aortic valve 2. Calcified lesion or atherosclerosis in the ascending aorta and/or aortic arch 3. Heavy calcified aortic valve (Ca. volume \> 500) 4. Chronic kidney disease 5. Prior stroke 6. Stroke risk is strongly anticipated by attending physicians * Compatible carotid and brachiocephalic artery anatomy for SENTINEL device as determined by Multi-Slice Computed Tomography scan or equivalent imaging modality * Agrees to the study protocol and the schedule of clinical follow-up and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site. Exclusion Criteria: * Vasculature in the right extremity precluding radial or brachial access * Excessive tortuosity in the right radial/brachial/subclavian artery preventing Sentinel System access and insertion * Inadequate circulation to the right extremity as evidenced by signs of artery occlusion (modified Allen's test) or absence of radial/brachial pulse * Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature * Symptomatic or asymptomatic severe occlusive carotid disease requiring concomitant carotid endarterectomy/stenting * Undergone carotid stenting or carotid endarterectomy within the previous 6 weeks * Concurrent medical condition with a life expectancy of less than 1 year
Where this trial is running
Bucheon and 10 other locations
- Bucheon Sejong Hospital — Bucheon, Korea, Republic of (COMPLETED)
- Keimyung University Dongsan Medical Center — Daegu, Korea, Republic of (COMPLETED)
- Chonnam National University Hospital — Gwangju, Korea, Republic of (COMPLETED)
- Seoul university Bundang hospital — Seongnam-si, Korea, Republic of (COMPLETED)
- Bundang CHA Hospital — Seongnam, Korea, Republic of (WITHDRAWN)
- Asan Medical Center — Seoul, Korea, Republic of (RECRUITING)
- Korea University Anam Hospital — Seoul, Korea, Republic of (COMPLETED)
- Samsung medical center — Seoul, Korea, Republic of (RECRUITING)
- Seoul National University Hospital — Seoul, Korea, Republic of (COMPLETED)
- Severance Hospital — Seoul, Korea, Republic of (COMPLETED)
- Pusan National University Yangsan Hospital — Yangsan, Korea, Republic of (TERMINATED)
Study contacts
- Study coordinator: Jung-hee Ham, Project manager
- Email: cvcrc5@amc.seoul.kr
- Phone: 82-2-3010-4728
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aortic Valve Disease, Transcatheter Aortic Valve Implantation, Transcatheter Aortic Valve Replacement, Cerebral protection