Cerebral Embolic Protection Device During TAVR

NCT07627984 | Completed

• 1 other identifier: CEPD01-001
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and effectiveness of the Cerebral Protection System (model CEP016F, Shanghai Shenqi Medical Technology Co., Ltd.) for capturing and removing thrombotic and tissue debris during transcatheter aortic valve replacement (TAVR).

Conditions

TAVR; Cerebral Embolicprotection Device

Keywords

cerebral embolicprotection device; TAVR

Outcome Measures

Primary Outcomes (1)

• The median total volume of new lesions within the protected brain territories, as assessed by diffusion-weighted magnetic resonance imaging (DW-MRI) at 2±1 days after TAVR.

  Protected brain territories are defined as the cerebral regions perfused exclusively by the vessels protected by the cerebral embolic protection device, namely the brachiocephalic artery and the left common carotid artery. Total volume of new lesions is defined as the sum of all newly detected diffusion-positive brain lesions on post-TAVR DW-MRI relative to pre-TAVR DW-MRI.

  At 2±1 days after TAVR.

Study Arms (2)

Use of a cerebral embolic protection device during TAVR

EXPERIMENTAL

Use of a cerebral embolic protection device during TAVR

Device: Cerebral embolic protection device

TAVR without the use of a cerebral embolic protection device

NO INTERVENTION

TAVR without the use of a cerebral embolic protection device

Interventions

Cerebral embolic protection device DEVICE

The cerebral embolic protection device is a percutaneously delivered dual-filter protection device designed to capture and remove dislodged debris during transcatheter aortic valve replacement (TAVR). The system utilizes one filter delivered to the brachiocephalic trunk (proximal filter) and a second filter delivered to the left common carotid artery (distal filter). Upon completion of the procedure, the filters and debris are retrieved back into the catheter and removed from the patient.

Use of a cerebral embolic protection device during TAVR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years, male or non-pregnant/non-lactating female.
• Suitable for TAVR and planned to undergo TAVR using an approved transcatheter aortic valve system.
• TAVR access limited to transfemoral or transapical approach.
• Imaging-confirmed left common carotid artery diameter of 6.5-10 mm and brachiocephalic artery diameter of 9-15 mm at the site of filter placement.
• No severe stenosis (\>70%), dilation, dissection, ostial aneurysm, or aneurysm within 3 cm of the aortic origin in the target vessels.
• Brain imaging evaluable by 3-Tesla magnetic resonance imaging.
• Willing to comply with protocol-required follow-up assessments.
• Written informed consent provided by the subject or legal guardian.

You may not qualify if:

• Impaired right upper limb blood flow.
• Intracranial hemorrhage, stroke, or transient ischemic attack within 6 months before procedure.
• Acute myocardial infarction within 1 month before procedure.
• Calcification in the intended filter deployment region.
• Planned pacemaker or defibrillator implantation within 30 days after TAVR.
• Left ventricular ejection fraction ≤20%.
• Infective endocarditis, intracardiac/aortic mass, thrombus, or vegetation on echocardiography.
• Severe occlusive carotid disease requiring concomitant carotid intervention, or carotid stenting/endarterectomy within 6 weeks.
• Leukopenia, acute anemia, thrombocytopenia, bleeding diathesis, or coagulation disorder.
• Active peptic ulcer disease or gastrointestinal bleeding within 3 months.
• Severe allergy or known contraindication to nitinol, stainless steel alloy, or contrast media.
• Contraindication to antiplatelet and/or anticoagulation therapy, or refusal of blood transfusion.
• Severe renal insufficiency (serum creatinine \>3.0 mg/dL, eGFR \<30 mL/min, or need for renal replacement therapy).
• Known psychiatric disease or substance abuse that may interfere with compliance or data interpretation.
• Life expectancy \<1 year.

Sponsors & Collaborators

• Shanghai Shenqi Medical Technology Co., Ltd: lead

Study Sites (1)

Xiamen Cardiovascular Hospital Xiamen University

Xiamen, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: June 4, 2026
• Study Start: September 20, 2023
• Primary Completion: April 16, 2025
• Study Completion: April 16, 2025
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)