Sentinel(TM) Post-Market Registry

Transcatheter Aortic Valve Replacement Clinical Trial

Official title:

Histopathology of Embolic Debris Captured During Transcatheter Aortic Valve Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02255851
• Other study ID #: CP10879
• Status: Completed
• Start date: March 2014
• Est. completion date: May 2016

Study information

• Verified date: May 2018
• Source: Claret Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The SENTINEL Post-Market Registry is a prospective, multi-center, registry using the CE-Marked Sentinel System in subjects with severe symptomatic calcified native aortic valve stenosis indicated for TAVR.

Subjects enrolled in the registry will undergo TAVR + Sentinel. Basic demographic information and detailed procedural data will be captured and documented in a registry case report form.

All Sentinel filters will be sent for histopathology at an independent core-lab.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Approved indications for commercially available CE-Marked TAVR devices.

2. Compatible left common carotid artery (6.5 - 10 mm) and brachiocephalic artery (9 - 15 mm) diameters without significant stenosis (> 70%).

3. The subject or the subject's legal representative has been informed of the nature of the registry, agrees to its provisions and has provided written informed consent as approved by the Ethics Committee of the respective site.

Exclusion Criteria:

1. Vasculature in the right extremity precluding 6Fr sheath radial/brachial access

2. Inadequate circulation to the right extremity as evidenced by signs of artery occlusion or absence of radial or brachial pulse

3. Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature

4. Patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, or who will refuse transfusion

5. Excessive tortuosity in the right radial/brachial/subclavian artery preventing Sentinel device access and insertion

6. Patient whose brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the ostium or within 3 cm of the ostium

7. Currently participating in an investigational drug or investigational (non CE-mark) device study

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Severe Symptomatic Calcified Native Aortic Valve Stenosis
• Transcatheter Aortic Valve Replacement

Intervention

Device:
• SENTINEL (Cerebral Protection System)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Claret Medical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Observational Endpoint	Capture rate, debris volume and histopathology analysis at day 1.	Post-Procedure (day 1)