Clinical trial NCT05217888: The Sentinel Registry
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Disease
Transcatheter Aortic Valve Implantation
Transcatheter Aortic Valve Replacement
Keywords: Cerebral protection
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
name: Boston Scientific Corporation
First posted: 2022-02-01
Enrollment: 158
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Undergoing TAVR(transcatheter aortic valve replacement) with the use of SENTINEL embolic protection device

Brief summary: This registry is to evaluate procedural outcomes and safety outcomes of cerebral protection devices during transfemoral TAVR in real-world clinical practice.

The data from this registry will be compared with the extracted data from the TP TAVR registry(NCT038262664) using Propensity Score Matching.


Eligibility 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

Primary outcomes:
measure: The rate of procedural success
timeFrame: 1 month
Secondary outcomes:
measure: The event rate of death from any cause
timeFrame: 1 month
measure: The event rate of cardiac death
timeFrame: 1 month
measure: The event rate of stroke
timeFrame: 1 month
measure: The event rate of myocardial infarction
timeFrame: 1 month
measure: The event rate of systemic embolic event
timeFrame: 1 month
measure: The event rate of vascular complication
timeFrame: 1 month
measure: The event rate of bleeding
timeFrame: 1 month
measure: The event rate of acute kidney injury
timeFrame: 1 month
measure: The event rate of repeat hospitalization
timeFrame: 1 month
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Bucheon Sejong Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul university Bundang hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
References: