Transcatheter Aortic Valve ReplacementNCT02255851
Sentinel(TM) Post-Market Registry
An observational study of Transcatheter Aortic Valve Replacement and Severe Symptomatic Calcified Native Aortic Valve Stenosis, run by Claret Medical.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transcatheter Aortic Valve Replacement, Severe Symptomatic Calcified Native Aortic Valve Stenosis
- What is being tested?
- SENTINEL (Cerebral Protection System)
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to May 2016
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Transcatheter Aortic Valve Replacement, Severe Symptomatic Calcified Native Aortic Valve Stenosis
- Being tested
- SENTINEL (Cerebral Protection System)
- Keywords
- selected for TAVR by heart team consensus, treated with CE-Marked TAVR devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENTINEL (Cerebral Protection System)Device
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | TAVR + SENTINEL (Cerebral Protection System) Receives: Device: SENTINEL (Cerebral Protection System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Observational Endpoint
Capture rate, debris volume and histopathology analysis at day 1.
Measured: Post-Procedure (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Aortic Valve ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Claret Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christoph Naber, MD, Principal investigator, Elisabeth-Krankenhaus Essen GmbH, Essen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255851
- Sponsor's protocol ID
- CP10879
- Status last verified
- May 2018
- First submitted
- 25 Sep 2014
- Last updated
- 23 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histopathology of Embolic Debris Captured During Transcatheter Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT02255851
- Acronym / sponsor ID
- CP10879
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Claret MedicalIndustry (pharma, biotech, devices)
- Study start
- Mar 2014 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 3 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | – | Device: SENTINEL (Cerebral Protection System)TAVR + SENTINEL (Cerebral Protection System) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SENTINEL (Cerebral Protection System) | Device | Treatment Group |
Primary outcome
Primary Observational Endpoint
Time frame: Post-Procedure (day 1)
Capture rate, debris volume and histopathology analysis at day 1.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
Related trials for Transcatheter Aortic Valve Replacement
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NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Recruiting
Low-dose Colchicine for Thromboprophylaxis After Transcatheter Aortic Valve Replacement
Transcatheter Aortic Valve Replacement, Transcatheter Heart Valve Thrombosis
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The JenaValve ALIGN-AR LVAD Registry
Aortic Regurgitation, Aortic Valve Insufficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Naber, MD principal investigator
Elisabeth-Krankenhaus Essen GmbH, Essen, Germany
Questions about this trial
What is this clinical trial studying?
An observational study of Transcatheter Aortic Valve Replacement and Severe Symptomatic Calcified Native Aortic Valve Stenosis, run by Claret Medical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Observational Endpoint (time frame: Post-Procedure (day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2018.