NCT06652841

Feasibility Study of the transShield Embolic Protection System

Prospective, Multi-center, Single Arm Feasibility Study of the transShield Embolic Protection System

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: TransAortic Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the initial safety and performance of the transShield EPS used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).

Detailed description

Patients 18 years of age and older, with severe aortic valve stenosis scheduled for a Transcatheter Aortic Valve Replacement (TAVR) procedure will be screened to determine eligibility and interest in the study. Patients who pass pre-screen eligibility criteria and are willing to participate in the study will be asked to sign the study Informed Consent Form before any study-specific tests or procedures are performed or for any study specific evaluations not considered standard of care that need to be performed to assess eligibility. All subjects enrolled in the study will be followed from baseline through post procedure, prior to discharge and conclude with a 30-day followup visit. The investigator will perform the percutaneous TAVR using a commercial TAVR system according to their institution's standard practice. After completion of the procedure, the transShield EPS Filter will be collected and shipped to an independent Core Lab for histopathology assessment of the embolic debris captured in the filter. Post procedure treatment and safety monitoring shall be completed per the investigator's standard guidelines and patients discharged when clinically stable, at the investigator's discretion. Prior to discharge, functional status, physical exam/vital signs, medications, safety assessment and hospital stay information shall be collected. Patients will be asked to return to the investigational site 30 days post procedure for functional status, physical exam/vital signs, medications, and safety assessment. If the patient is not able to return to the investigational site, the visit may be completed via a tele-health visit with the investigator in combination with an in-office visit to the patient's local General Practitioner (GP) or Cardiologist. This visit will conclude the patient's participation in the study.

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	transShield Embolic Protection System	Patient undergoing TAVR procedure will receive the transShield EPS with the intent to capture and remove debris dislodged during the interventional procedure.

Timeline

• Start date: 2025-03-26
• Primary completion: 2025-08-05
• Completion: 2025-08-05
• First posted: 2024-10-22
• Last updated: 2025-08-14

Locations

1 site across 1 country: New Zealand

Regulatory

• FDA-regulated device study