Sentinel(TM) Post-Market Registry

Histopathology of Embolic Debris Captured During Transcatheter Aortic Valve Replacement

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.

Study Overview

• Status: Completed
• Conditions: Transcatheter Aortic Valve Replacement; Severe Symptomatic Calcified Native Aortic Valve Stenosis
• Intervention / Treatment: Device: SENTINEL (Cerebral Protection System)

• Study Type: Observational
• Enrollment (Actual): 300

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The registry population comprises subjects with severe symptomatic calcified native aortic valve stenosis who are selected for TAVR by heart team consensus and treated with CE-Marked TAVR devices.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment Group; TAVR + SENTINEL (Cerebral Protection System)	Device: SENTINEL (Cerebral Protection System)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Observational Endpoint	Capture rate, debris volume and histopathology analysis at day 1.	Post-Procedure (day 1)

Collaborators and Investigators

• Sponsor: Claret Medical
• Investigators: Principal Investigator: Christoph Naber, MD, Elisabeth-Krankenhaus Essen GmbH, Essen, Germany

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2014
• Primary Completion (ACTUAL): May 1, 2016
• Study Completion (ACTUAL): May 1, 2016

Study Registration Dates

• First Submitted: September 25, 2014
• First Submitted That Met QC Criteria: October 2, 2014
• First Posted (ESTIMATE): October 3, 2014

Study Record Updates

• Last Update Posted (ACTUAL): May 23, 2018
• Last Update Submitted That Met QC Criteria: May 22, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: selected for TAVR by heart team consensus; treated with CE-Marked TAVR devices
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: CP10879