NCT02255851

Completed

Sentinel(TM) Post-Market Registry

Claret Medical Source

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Other study identifiers

Sponsor study identifier

CP10879

Study Type

observational

Actual enrollment (reported)

300

Locations

0 countries

Sites

N/A

Timeline

Study Start

March 2014

Actual (reported)

Primary Completion

May 2016

Actual (reported)

Study Completion

May 2016

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 300 participants
Study completion date: May 2016
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 2014
Actual (reported)
First Submitted
September 25, 2014
Actual (reported)
First Posted
October 3, 2014
Actual (reported)
Primary Completion
May 2016
Actual (reported)
Study Completion
May 2016
Actual (reported)

Last Updated: May 23, 2018
Status Verified: May 2018
Last Update Submitted: May 22, 2018

Conditions

Severe Symptomatic Calcified Native Aortic Valve Stenosis Transcatheter Aortic Valve Replacement

Keywords

selected for TAVR by heart team consensustreated 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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

Sponsors & Collaborators

Claret Medical
Industrylead

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

Enrollment

300 participants (actual enrollment reported by the registry).

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 2014

Actual (reported)

NCT02723422

Transcatheter Aortic Valve Replacement (TAVR)-Pilot Trial

Not ApplicableWithdrawn

NCT01777828

Registry of Aortic Valve Bioprostheses Established by Catheter

Recruiting

NCT03117296

Physical Therapy and Occupational Therapy After Transcatheter Aortic Valve Replacement

Completed

NCT01627691

REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System

Not ApplicableCompleted

NCT01935297

Exercise Training After Transcatheter Aortic Valve Implantation

Not ApplicableCompleted

NCT02812953

Biological Collection and Registry of Patients Who Will Have a TAVR (Transcatheter Aortic Valve Replacement) Intervention

Unknown

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

Contact the study team to confirm eligibility.

Primary Completion

May 2016

Actual (reported)

Study Completion

May 2016

Actual (reported)

Last Updated

May 23, 2018

Record last verified: 2018-05

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02255851
Data provider: ClinicalTrials.gov
Source updated: 2018-05-23
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:32:39 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Treatment Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Biospecimen

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record