Aortic Valve StenosisNCT04131127
Sentinel Low Risk Registry
An observational study of Aortic Valve Stenosis, run by CVPath Institute Inc. at 4 sites in United States.
Trial summary
This registry is designed to quantify embolic debris capture rate in patients at low surgical risk treated with the Sentinel System during TAVI. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Sentinel Device
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 Jan 2020to 19 Aug 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population is comprised of subjects with severe native aortic valve stenosis who meet the commercially approved indications for TAVI and comply with the inclusion/exclusion criteria described below.
Who may be able to join
- Severe symptomatic aortic valve stenosis
- Planned use of Sentinel System
- Subject planned for transfemoral TAVI with valve system approved by U.S. FDA for low risk patients
- STS-PROM score of less than 4% and agreement by Heart Team that patients meet criteria for low surgical risk
Who cannot join
- Current or recent cerebrovascular accident (stroke, TIA) <6 months
- Transapical, direct aortic or subclavian TAVI access
- Carotid stenting or endarterectomy in last 6 weeks
- Prior aortic valve replacement
- Concomitant procedure with TAVI such as CABG, PCI, etc.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Carolinas Medical Center
Charlotte, North Carolina, 28203
Cleveland Clinic
Cleveland, Ohio, 44195
Columbia University Medical Center
New York, New York, 10032
UPMC Pinnacle
Wormleysburg, Pennsylvania, 17043
About this study
Official title: Cerebral Protection of Acute Embolic Burden During Transcatheter Aortic Valve Implantation in Low Risk Patients
This registry is designed to quantify embolic debris capture rate in patients at low surgical risk treated with the Sentinel System during TAVI.
Read the detailed description
The SENTINEL-LIR Study is a multicenter, prospective registry to observe rate and type of debris capture in subjects at low surgical risk undergoing TAVI to demonstrate the positive effects of the use of the Sentinel System. Histopathology of captured debris from the Sentinel System will be analyzed.
The primary objective is to determine the presence or absence of particles of 7 discreet tissue types: acute thrombus (with or without associated tissue/foreign material), organizing thrombus, valve tissue, arterial wall/necrotic core, calcification, foreign material, and myocardium. Morphometric assessment of the debris (sizes >150 m, >500 m, and >1,000 m).
Patients will be screened for inclusion and exclusion criteria and documents which will have been reviewed and approved by the local Ethics Committee or regulatory authority prior to undergoing any study related exams or procedures.
Fifty (50) subjects will be enrolled in the study from an estimated 6 different sites.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Sentinel Device
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel DeviceDevice
Sentinel Device used during TAVI in a Low Risk Patient
What is being measured
The primary outcome is the main question the study is designed to answer.
The SENTINEL-LIR Study
To determine the incidence and type of debris capture in SENTINEL devices deployed during TAVI in patients at low surgical risk
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start7 Jan 2020
- Primary completion19 Aug 2020
- Study completion19 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- CVPath Institute Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Aloke V Finn, MD, Principal investigator, CVPath Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131127
- Sponsor's protocol ID
- CP2561-0316
- Status last verified
- Oct 2020
- First submitted
- 16 Oct 2019
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Publications
Seeger J, Kapadia SR, Kodali S, Linke A, Wohrle J, Haussig S, Makkar R, Mehran R, Rottbauer W, Leon M. Rate of peri-procedural stroke observed with cerebral embolic protection during transcatheter aortic valve replacement: a patient-level propensity-matched analysis. Eur Heart J. 2019 May 1;40(17):1334-1340. doi: 10.1093/eurheartj/ehy847.
PubMed 30590554Schmidt T, Leon MB, Mehran R, Kuck KH, Alu MC, Braumann RE, Kodali S, Kapadia SR, Linke A, Makkar R, Naber C, Romero ME, Virmani R, Frerker C. Debris Heterogeneity Across Different Valve Types Captured by a Cerebral Protection System During Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2018 Jul 9;11(13):1262-1273. doi: 10.1016/j.jcin.2018.03.001.
PubMed 29976363Lazar RM, Pavol MA, Bormann T, Dwyer MG, Kraemer C, White R, Zivadinov R, Wertheimer JC, Thone-Otto A, Ravdin LD, Naugle R, Mechanic-Hamilton D, Garmoe WS, Stringer AY, Bender HA, Kapadia SR, Kodali S, Ghanem A, Linke A, Mehran R, Virmani R, Nazif T, Parhizgar A, Leon MB. Neurocognition and Cerebral Lesion Burden in High-Risk Patients Before Undergoing Transcatheter Aortic Valve Replacement: Insights From the SENTINEL Trial. JACC Cardiovasc Interv. 2018 Feb 26;11(4):384-392. doi: 10.1016/j.jcin.2017.10.041. Epub 2018 Feb 1.
PubMed 29397361Kapadia 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 27815101Kawakami R, Gada H, Rinaldi MJ, Nazif TM, Leon MB, Kapadia S, Krishnaswamy A, Sakamoto A, Sato Y, Mori M, Kawai K, Cornelissen A, Park JE, Ghosh SKB, Abebe BG, Romero M, Virmani R, Finn AV. Characterization of Cerebral Embolic Capture Using the SENTINEL Device During Transcatheter Aortic Valve Implantation in Low to Intermediate-Risk Patients: The SENTINEL-LIR Study. Circ Cardiovasc Interv. 2022 Apr;15(4):e011358. doi: 10.1161/CIRCINTERVENTIONS.121.011358. Epub 2022 Mar 11. No abstract available.
PubMed 35272475
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Protection of Acute Embolic Burden During Transcatheter Aortic Valve Implantation in Low Risk Patients
- ClinicalTrials.gov ID
- NCT04131127
- Acronym / sponsor ID
- CP2561-0316
- Conditions
- Aortic Valve Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- CVPath Institute Inc.University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 19 Aug 2020 (actual)
- Study completion
- 19 Aug 2020 (actual)
- First posted
- 18 Oct 2019 (actual)
- 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.
This registry is designed to quantify embolic debris capture rate in patients at low surgical risk treated with the Sentinel System during TAVI.
Detailed description
The SENTINEL-LIR Study is a multicenter, prospective registry to observe rate and type of debris capture in subjects at low surgical risk undergoing TAVI to demonstrate the positive effects of the use of the Sentinel System. Histopathology of captured debris from the Sentinel System will be analyzed.
The primary objective is to determine the presence or absence of particles of 7 discreet tissue types: acute thrombus (with or without associated tissue/foreign material), organizing thrombus, valve tissue, arterial wall/necrotic core, calcification, foreign material, and myocardium. Morphometric assessment of the debris (sizes >150 m, >500 m, and >1,000 m).
Patients will be screened for inclusion and exclusion criteria and documents which will have been reviewed and approved by the local Ethics Committee or regulatory authority prior to undergoing any study related exams or procedures.
Fifty (50) subjects will be enrolled in the study from an estimated 6 different sites.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population is comprised of subjects with severe native aortic valve stenosis who meet the commercially approved indications for TAVI and comply with the inclusion/exclusion criteria described below.
Key inclusion criteria (4 listed)
- Severe symptomatic aortic valve stenosis
- Planned use of Sentinel System
- Subject planned for transfemoral TAVI with valve system approved by U.S. FDA for low risk patients
- STS-PROM score of less than 4% and agreement by Heart Team that patients meet criteria for low surgical risk
Key exclusion criteria (5 listed)
- Current or recent cerebrovascular accident (stroke, TIA) <6 months
- Transapical, direct aortic or subclavian TAVI access
- Carotid stenting or endarterectomy in last 6 weeks
- Prior aortic valve replacement
- Concomitant procedure with TAVI such as CABG, PCI, etc.
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 DeviceSentinel Device used during TAVI in a Low Risk Patient | Device | – |
Primary outcome
The SENTINEL-LIR Study
Time frame: 12 months
To determine the incidence and type of debris capture in SENTINEL devices deployed during TAVI in patients at low surgical risk
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 19 Oct 2020.
- Background: PubMed 30590554Seeger J, Kapadia SR, Kodali S, Linke A, Wohrle J, Haussig S, Makkar R, Mehran R, Rottbauer W, Leon M. Rate of peri-procedural stroke observed with cerebral embolic protection during transcatheter aortic valve replacement: a patient-level propensity-matched analysis. Eur Heart J. 2019 May 1;40(17):1334-1340. doi: 10.1093/eurheartj/ehy847.
- Background: PubMed 29976363Schmidt T, Leon MB, Mehran R, Kuck KH, Alu MC, Braumann RE, Kodali S, Kapadia SR, Linke A, Makkar R, Naber C, Romero ME, Virmani R, Frerker C. Debris Heterogeneity Across Different Valve Types Captured by a Cerebral Protection System During Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2018 Jul 9;11(13):1262-1273. doi: 10.1016/j.jcin.2018.03.001.
- Background: PubMed 29397361Lazar RM, Pavol MA, Bormann T, Dwyer MG, Kraemer C, White R, Zivadinov R, Wertheimer JC, Thone-Otto A, Ravdin LD, Naugle R, Mechanic-Hamilton D, Garmoe WS, Stringer AY, Bender HA, Kapadia SR, Kodali S, Ghanem A, Linke A, Mehran R, Virmani R, Nazif T, Parhizgar A, Leon MB. Neurocognition and Cerebral Lesion Burden in High-Risk Patients Before Undergoing Transcatheter Aortic Valve Replacement: Insights From the SENTINEL Trial. JACC Cardiovasc Interv. 2018 Feb 26;11(4):384-392. doi: 10.1016/j.jcin.2017.10.041. Epub 2018 Feb 1.
- Background: 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.
- Derived from this study: PubMed 35272475Kawakami R, Gada H, Rinaldi MJ, Nazif TM, Leon MB, Kapadia S, Krishnaswamy A, Sakamoto A, Sato Y, Mori M, Kawai K, Cornelissen A, Park JE, Ghosh SKB, Abebe BG, Romero M, Virmani R, Finn AV. Characterization of Cerebral Embolic Capture Using the SENTINEL Device During Transcatheter Aortic Valve Implantation in Low to Intermediate-Risk Patients: The SENTINEL-LIR Study. Circ Cardiovasc Interv. 2022 Apr;15(4):e011358. doi: 10.1161/CIRCINTERVENTIONS.121.011358. Epub 2022 Mar 11. No abstract available.
- Individual participant dataSharing planned: Yes
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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.
Aloke V Finn, MD principal investigator
CVPath Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by CVPath Institute Inc. at 4 sites in United States.
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 4 inclusion and 5 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 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
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?
The SENTINEL-LIR Study (time frame: 12 months). 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 NCT04131127, which also lists 5 linked publications.
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 19 Oct 2020.