Sentinel Low Risk Registry
Cerebral Protection of Acute Embolic Burden During Transcatheter Aortic Valve Implantation in Low Risk Patients
1 other identifier
observational
50
1 country
4
Brief Summary
This registry is designed to quantify embolic debris capture rate in patients at low surgical risk treated with the Sentinel System during TAVI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2020
Shorter than P25 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2019
CompletedFirst Posted
Study publicly available on registry
October 18, 2019
CompletedStudy Start
First participant enrolled
January 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 19, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 19, 2020
CompletedOctober 19, 2020
October 1, 2020
8 months
October 16, 2019
October 16, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
12 months
Interventions
Sentinel Device used during TAVI in a Low Risk Patient
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CVPath Institute Inc.lead
- Boston Scientific Corporationcollaborator
Study Sites (4)
Columbia University Medical Center
New York, New York, 10032, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
UPMC Pinnacle
Wormleysburg, Pennsylvania, 17043, United States
Related Publications (5)
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.
PMID: 30590554BACKGROUNDSchmidt 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.
PMID: 29976363BACKGROUNDLazar 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.
PMID: 29397361BACKGROUNDKapadia 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.
PMID: 27815101BACKGROUNDKawakami 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.
PMID: 35272475DERIVED
Biospecimen
We will collect debris that have been captured in the Sentinel filter and perform pathology on those specimens
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aloke V Finn, MD
CVPath Institute
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2019
First Posted
October 18, 2019
Study Start
January 7, 2020
Primary Completion
August 19, 2020
Study Completion
August 19, 2020
Last Updated
October 19, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF