Clinical study protocol for the use of Sentinel cerebral protection device during TAVR to prevent new brain injuries

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500105954

Enrollment

Unknown

Registered

2025-07-15

Start date

2025-07-15

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic stenosis

Interventions

A:Sentinel protection during TAVR

B:TAVR without Sentinel protection

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1 There is severe calcific aortic valve stenosis, and echocardiography and/or invasive hemodynamic testing shows aortic valve orifice area = 40 mmHg or ejection rate >= 4.0 m/s. Dopamine stress test should be performed to distinguish suspected low-flow, low-gradient severe aortic valve stenosis. 2 The patient has symptoms of aortic valve stenosis and New York Heart Association (NYHA) functional class >= II. 3 Anatomical conditions are suitable for trans-femoral TAVR, with appropriate measurements for aortic valve annulus diameter, leaflet calcification distribution and degree, sinus of Valsalva diameter and height, coronary artery ostia height, and peripheral artery diameter, etc., to meet the requirements of appropriate devices. 4 Anatomical conditions are suitable for the use of the Sentinel cerebral protection device during TAVR. 5 Elective surgery. 6 Expected survival life span >1 year.

Exclusion criteria

Exclusion criteria: 1 History of stroke within one year prior to TAVR 2 Previous history of brain tumor, cerebral hemorrhage, brain abscess, cerebral angioma, encephalitis, neurological infection, or head trauma 3 Previous chest surgery or transcatheter heart valve replacement 4 Implanted a cardiac pacemaker incompatible with magnetic resonance imaging 5 Fear of enclosed spaces 6 Previous internal metallic implants (including removable dentures that are expected to affect MRI image quality) 7 Left ventricular ejection fraction <30% 8 Patients at high risk for the need of permanent pacemaker after TAVR, such as those with atrioventricular block or bundle branch block at baseline 9 Patients expected to be non-cooperative for postoperative follow-up

Design outcomes

Primary

Measure	Time frame
Quantitative Susceptibility Mapping;Incidence and number of new brain lesions after TAVR;	—

Countries

China

Contacts

Public ContactMao Chen

West China Hospital of Sichuan University

hmaochen@vip.sina.com+86 189 8060 2046

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026