Ignite Creation Date:
2024-10-25 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652841
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Feasibility Study of the transShield Embolic Protection System
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Multi-center Single Arm Feasibility Study of the transShield Embolic Protection System
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 institutions 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 investigators standard guidelines and patients discharged when clinically stable at the investigators discretion Prior to discharge functional status physical examvital 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 examvital 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 patients local General Practitioner GP or Cardiologist This visit will conclude the patients participation in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None