Severe Symptomatic Calcified Native Aortic Valve StenosisNCT02214277
Cerebral Protection in Transcatheter Aortic Valve Replacement
A study testing Cerebral Protection System-The SENTINEL System with TAVR and TAVR in people with Severe Symptomatic Calcified Native Aortic Valve Stenosis, run by Claret Medical at 15 sites in 2 countries.
Trial summary
The Sentinel System will be a safe and effective method for capturing and removing embolic material (thrombus/debris) during transcatheter aortic valve replacement in order to reduce the ischemic burden in the cerebral anterior circulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Symptomatic Calcified Native Aortic Valve Stenosis
- What is being tested?
- Cerebral Protection System-The SENTINEL System with TAVR and TAVR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 363 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Sep 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Approved indications for commercially available Edwards SAPIEN Transcatheter Heart Valve, model 9000TFX or SAPIEN XT, model 9300TFX meeting one of the three sub-criteria below:
- SAPIEN
- transfemoral delivery in subjects with severe symptomatic calcified native aortic valve stenosis without severe aortic insufficiency and with ejection fraction >20% who have been examined by a heart team including an experienced cardiac surgeon and a cardiologist and found to either be:
- inoperable and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis; or
- be operative candidates for aortic valve replacement but who have a Society of Thoracic Surgeons predicted operative risk score >8% or are judged by the heart team to be at a 15% risk of mortality for surgical aortic valve replacement.
- or
Show all 12Show fewer
- transapical delivery in subjects with severe symptomatic calcified native aortic valve stenosis without severe aortic insufficiency and with ejection fraction > 20% who have been examined by a heart team including an experienced cardiac surgeon and a cardiologist and found to be operative candidates for aortic valve replacement but who have a Society of Thoracic Surgeons operative risk score 8% or are judged by the heart team to be at a 15% risk of mortality for surgical aortic valve replacement.
- SAPIEN XT (Transfemoral or Transapical only)
- in patients with symptomatic heart disease due to severe native calcific aortic stenosis (aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2, a mean aortic valve gradient of ≥ 40 mmHg, or a peak aortic-jet velocity of ≥ 4.0 m/s), and with native anatomy appropriate for the 23, 26, or 29 mm valve system, who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., Society of Thoracic Surgeons operative risk score ≥8% or at a ≥15% risk of mortality at 30 days).
- Compatible left common carotid artery (6.5 - 10 mm) and brachiocephalic artery (9 - 15 mm) diameters without significant stenosis (> 70%) as determined by Multi-Slice Computed Tomography (MSCT) scan or equivalent imaging modality
- The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visit
- The subject or the subject's legal representative has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the IRB of the respective clinical site
Who cannot join
- General
- Vasculature in the right extremity precluding 6Fr sheath radial or brachial access
- Inadequate circulation to the right extremity as evidenced by signs of artery occlusion (modified Allen's test) or absence of radial/brachial pulse
- Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature
- Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment
- Aortic valve is a congenital unicuspid or bicuspid valve; or is non-calcified
Show all 41Show fewer
- Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+)
- Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease)
- Pre-existing prosthetic heart valve in any position, prosthetic ring, or severe (greater than 3+) mitral insufficiency
- Blood dyscrasias as defined: Leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy
- Hemodynamic instability requiring inotropic support or mechanical heart assistance.
- Need for emergency surgery for any reason
- Hypertrophic cardiomyopathy with or without obstruction
- Severe ventricular dysfunction with LVEF ≤20%
- Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation
- Symptomatic or asymptomatic severe occlusive carotid disease requiring concomitant CEA/stenting
- Subject has undergone carotid stenting or carotid endarterectomy within the previous 6 weeks
- Active peptic ulcer or upper GI bleeding within the prior 3 months
- A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, or clopidogrel, or sensitivity to contrast media, which cannot be adequately pre-medicated
- Recent (within 6 months) CVA or a TIA
- Renal insufficiency (creatinine > 3.0 mg/dL or GFR < 30) and/or renal replacement therapy at the time of screening
- Life expectancy < 12 months due to non-cardiac co-morbid conditions
- Subjects in whom anti-platelet and/or anticoagulant therapy is contraindicated, or who will refuse transfusion
- Subjects who have active bacterial endocarditis or other active infections
- Currently participating in an investigational drug or another device study
- Subjects who have a planned treatment with any other investigational device or procedure during the study follow-up period (90 days)
- Subject with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation during the study follow-up period (90 days)
- Any subject with a balloon valvuloplasty (BAV) within 30 days of the procedure
- Neurologic
- Subject had active major psychiatric disease
- Subject has severe visual, auditory, or learning impairment and who are unable to comprehend English and therefore unable to be consented for the study
- Subjects with neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities
- Angiographic
- Excessive tortuosity in the right radial/brachial/subclavian artery preventing Sentinel System access and insertion
- Subject whose brachiocephalic or left carotid artery reveals significant stenosis, calcification, ectasia, dissection, or aneurysm at the ostium or within 3 cm of the ostium
- Magnetic Resonance Imaging
- Subject Body Mass Index (BMI) precluding imaging in scanner
- Contraindications to MRI (subjects with any implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVR procedure)
- Planned implantation of a pacemaker or defibrillator implantation after TAVR
- Claustrophobia
- Known allergy to gadolinium or contrast agent
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States14 sites
Emory University Hospital
Atlanta, Georgia
UVA Advanced Cardiac Valve Center
Charlottesville, Virginia
Morton Plant Hospital
Clearwater, Florida
Cleveland Clinic Foundation
Cleveland, Ohio
Henry Ford Hospital
Detroit, Michigan
UT Houston / Memorial Hermann
Houston, Texas
Cedars-Sinai Medical Center
Los Angeles, California
Columbia University Medical Center
New York, New York
Icahn School of Medicine at Mount Sinai
New York, New York
Weill Cornell Medical Center
New York, New York
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania
UW Medical Center
Seattle, Washington
Barnes-Jewish Hospital
St Louis, Missouri
Washington Hospital Center
Washington D.C., District of Columbia
About this study
Official title: Cerebral Protection in Transcatheter Aortic Valve Replacement - The SENTINEL Study
The Sentinel System will be a safe and effective method for capturing and removing embolic material (thrombus/debris) during transcatheter aortic valve replacement in order to reduce the ischemic burden in the cerebral anterior circulation.
Read the detailed description
The Sentinel™ Cerebral Protection System is indicated for use as an embolic capture and retrieval system intended to reduce the ischemic burden in the cerebral anterior circulation while performing transcatheter aortic valve replacement.
The objective of this study is to assess the safety and efficacy of the Claret Medical Sentinel Cerebral Protection System used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR) compared to TAVR standard of care (without embolic protection).
The study population is comprised of subjects with severe symptomatic calcified native aortic valve stenosis who meet the commercially approved indications for TAVR with the Edwards SAPIEN THV or SAPIEN XT and comply with the inclusion/exclusion criteria.
- Being tested
- Cerebral Protection System-The SENTINEL System with TAVR, TAVR
- Keywords
- Embolic Protection, Edwards SAPIEN THV, Edwards SAPIEN XT, TAVR, Transfemoral, Transapical, Heart Valve Diseases, Heart Diseases, TAVI, Aortic Stenosis, Aortic Valve, Transcatheter Heart Valve
- Medical subject headings
- Heart Valve Diseases, Heart Diseases, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral Protection System-The SENTINEL System with TAVRDevice
Also called Cerebral Protection System: The SENTINEL System, TAVR Device: Edwards SAPIEN THV or Edwards SAPIEN XT
Claret Medical Sentinel Cerebral Protection System is intended for use as an embolic protection system to contain and remove embolic material (thrombus/debris) that may enter the carotid arteries.
TAVRDevice
Also called TAVR: Edwards SAPIEN THV or Edwards SAPIEN XT
| Study group | Role | What they receive |
|---|---|---|
| Test Arm | Experimental | Not described Receives: Device: Cerebral Protection System-The SENTINEL System with TAVR |
| Control Arm | Active comparator | Not described Receives: Device: TAVR |
| Safety Arm | Other | Not described Receives: Device: Cerebral Protection System-The SENTINEL System with TAVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Median Total New Lesion Volume in Protected Territories Between Test and Control Arms as Assessed by DW-MRI at Day 2-7 Post-procedure.
Total new lesion volume is defined as the sum of all diffusion-positive new cerebral lesions in post-TAVR DW-MRI relative to the pre-TAVR DW-MRI scans. Protected territories are defined as brain territories uniquely perfused by the vessels protected by the Sentinel System, namely the left and right carotid arteries, and the right vertebral artery.
Measured: Day 2-7 Post-Procedure
Patients With Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 Days
Primary Safety Endpoint: MACCE (all death, all stroke, and acute kidney injury class 3 within 72 hours or discharge, whatever occurs first) at 30 days compared to a historical performance goal of 18.3%.
Measured: 30 Days Post-Procedure
Secondary outcomes (1)
Captured Debris Histopathology (Observational)
Measured: Post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Symptomatic Calcified Native Aortic Valve StenosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claret Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susheel Kodali, MD, Principal investigator, Columbia UniversitySamir Kapadia, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214277
- Sponsor's protocol ID
- CP-10836
- Status last verified
- Apr 2018
- First submitted
- 8 Aug 2014
- Last updated
- 11 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kapadia SR, Kodali S, Makkar R, Mehran R, Lazar RM, Zivadinov R, Dwyer MG, Jilaihawi H, Virmani R, Anwaruddin S, Thourani VH, Nazif T, Mangner N, Woitek F, Krishnaswamy A, Mick S, Chakravarty T, Nakamura M, McCabe JM, Satler L, Zajarias A, Szeto WY, Svensson L, Alu MC, White RM, Kraemer C, Parhizgar A, Leon MB, Linke A; SENTINEL Trial Investigators. Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2017 Jan 31;69(4):367-377. doi: 10.1016/j.jacc.2016.10.023. Epub 2016 Nov 1.
PubMed 27815101
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Protection in Transcatheter Aortic Valve Replacement - The SENTINEL Study
- ClinicalTrials.gov ID
- NCT02214277
- Acronym / sponsor ID
- CP-10836
- Keywords
- Embolic Protection, Edwards SAPIEN THV, Edwards SAPIEN XT, TAVR, Transfemoral, Transapical, Heart Valve Diseases, Heart Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- Claret MedicalIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 12 Aug 2014 (estimated)
- Results
- Posted 11 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Sentinel System will be a safe and effective method for capturing and removing embolic material (thrombus/debris) during transcatheter aortic valve replacement in order to reduce the ischemic burden in the cerebral anterior circulation.
Detailed description
The Sentinel™ Cerebral Protection System is indicated for use as an embolic capture and retrieval system intended to reduce the ischemic burden in the cerebral anterior circulation while performing transcatheter aortic valve replacement.
The objective of this study is to assess the safety and efficacy of the Claret Medical Sentinel Cerebral Protection System used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR) compared to TAVR standard of care (without embolic protection).
The study population is comprised of subjects with severe symptomatic calcified native aortic valve stenosis who meet the commercially approved indications for TAVR with the Edwards SAPIEN THV or SAPIEN XT and comply with the inclusion/exclusion criteria.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Arm | Experimental | Device: Cerebral Protection System-The SENTINEL System with TAVR |
| Control Arm | Active comparator | Device: TAVR |
| Safety Arm | Other | Device: Cerebral Protection System-The SENTINEL System with TAVR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Approved indications for commercially available Edwards SAPIEN Transcatheter Heart Valve, model 9000TFX or SAPIEN XT, model 9300TFX meeting one of the three sub-criteria below:
- SAPIEN
- or
- SAPIEN XT (Transfemoral or Transapical only)
- Compatible left common carotid artery (6.5 - 10 mm) and brachiocephalic artery (9 - 15 mm) diameters without significant stenosis (> 70%) as determined by Multi-Slice Computed Tomography (MSCT) scan or equivalent imaging modality
Key exclusion criteria (41 listed)
- General
- Vasculature in the right extremity precluding 6Fr sheath radial or brachial access
- Inadequate circulation to the right extremity as evidenced by signs of artery occlusion (modified Allen's test) or absence of radial/brachial pulse
- Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature
- Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment
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 |
|---|---|---|
| Cerebral Protection System-The SENTINEL System with TAVRAlso: Cerebral Protection System: The SENTINEL System, TAVR Device: Edwards SAPIEN THV or Edwards SAPIEN XTClaret Medical Sentinel Cerebral Protection System is intended for use as an embolic protection system to contain and remove embolic material (thrombus/debris) that may enter the carotid arteries. | Device | Safety Arm, Test Arm |
| TAVRAlso: TAVR: Edwards SAPIEN THV or Edwards SAPIEN XT | Device | Control Arm |
Primary outcome
Reduction in Median Total New Lesion Volume in Protected Territories Between Test and Control Arms as Assessed by DW-MRI at Day 2-7 Post-procedure.
Time frame: Day 2-7 Post-Procedure
Total new lesion volume is defined as the sum of all diffusion-positive new cerebral lesions in post-TAVR DW-MRI relative to the pre-TAVR DW-MRI scans. Protected territories are defined as brain territories uniquely perfused by the vessels protected by the Sentinel System, namely the left and right carotid arteries, and the right vertebral artery.
Patients With Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 Days
Time frame: 30 Days Post-Procedure
Primary Safety Endpoint: MACCE (all death, all stroke, and acute kidney injury class 3 within 72 hours or discharge, whatever occurs first) at 30 days compared to a historical performance goal of 18.3%.
1 secondary outcome
Captured Debris Histopathology (Observational)
Time frame: Post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27815101Kapadia SR, Kodali S, Makkar R, Mehran R, Lazar RM, Zivadinov R, Dwyer MG, Jilaihawi H, Virmani R, Anwaruddin S, Thourani VH, Nazif T, Mangner N, Woitek F, Krishnaswamy A, Mick S, Chakravarty T, Nakamura M, McCabe JM, Satler L, Zajarias A, Szeto WY, Svensson L, Alu MC, White RM, Kraemer C, Parhizgar A, Leon MB, Linke A; SENTINEL Trial Investigators. Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2017 Jan 31;69(4):367-377. doi: 10.1016/j.jacc.2016.10.023. Epub 2016 Nov 1.
- Related InfoLink provided by the sponsor.
Related trials for Severe Symptomatic Calcified Native Aortic Valve Stenosis
Not yet recruiting
Validation Of anatomY-specific Aortic Valve Implantation Guided by Software Using EncantoR
Severe Native Calcific Aortic Stenosis, Symptomatic Heart Disease Due to Severe Native Calcific Aortic Stenosis
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.
Susheel Kodali, MD principal investigator
Columbia University
Samir Kapadia, MD principal investigator
The Cleveland Clinic
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebral Protection System-The SENTINEL System with TAVR and TAVR in people with Severe Symptomatic Calcified Native Aortic Valve Stenosis, run by Claret Medical at 15 sites in 2 countries.
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 12 inclusion and 41 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 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 11 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Reduction in Median Total New Lesion Volume in Protected Territories Between Test and Control Arms as Assessed by DW-MRI at Day 2-7 Post-procedure. (time frame: Day 2-7 Post-Procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02214277, which also lists 1 linked publication.
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 11 May 2018.