Sentinel(TM) Post-Market Registry

NCT02255851 | Completed

• 1 other identifier: CP10879
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

selected for TAVR by heart team consensus; treated with CE-Marked TAVR devices

Outcome Measures

Primary Outcomes (1)

• Primary Observational Endpoint

  Capture rate, debris volume and histopathology analysis at day 1.

  Post-Procedure (day 1)

Study Arms (1)

Treatment Group

TAVR + SENTINEL (Cerebral Protection System)

Device: SENTINEL (Cerebral Protection System)

Interventions

SENTINEL (Cerebral Protection System) DEVICE

Treatment Group

Eligibility Criteria

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

You may qualify if:

• Approved indications for commercially available CE-Marked TAVR devices.
• Compatible left common carotid artery (6.5 - 10 mm) and brachiocephalic artery (9 - 15 mm) diameters without significant stenosis (\> 70%).
• 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.

You may not qualify if:

• Vasculature in the right extremity precluding 6Fr sheath radial/brachial access
• Inadequate circulation to the right extremity as evidenced by signs of artery occlusion or absence of radial or brachial pulse
• Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature
• Patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, or who will refuse transfusion
• Excessive tortuosity in the right radial/brachial/subclavian artery preventing Sentinel device access and insertion
• Patient whose brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the ostium or within 3 cm of the ostium
• Currently participating in an investigational drug or investigational (non CE-mark) device study

Sponsors & Collaborators

• Claret Medical: lead

Biospecimen

Retention: SAMPLES WITH DNA

Capture and histopathology analysis of embolic debris. (Thrombus, valve tissue, amorphous calcium, etc.)

Study Officials

• Christoph Naber, MD

  Elisabeth-Krankenhaus Essen GmbH, Essen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: October 3, 2014
• Study Start: March 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 23, 2018

Record last verified: 2018-05