Sentinel Low Risk Registry

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: Sentinel Device

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Wormleysburg, Pennsylvania, United States, 17043
      • UPMC Pinnacle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

1. Severe symptomatic aortic valve stenosis
2. Planned use of Sentinel System
3. Subject planned for transfemoral TAVI with valve system approved by U.S. FDA for low risk patients
4. STS-PROM score of less than 4% and agreement by Heart Team that patients meet criteria for low surgical risk

Exclusion Criteria:

1. Current or recent cerebrovascular accident (stroke, TIA) <6 months
2. Transapical, direct aortic or subclavian TAVI access
3. Carotid stenting or endarterectomy in last 6 weeks
4. Prior aortic valve replacement
5. Concomitant procedure with TAVI such as CABG, PCI, etc.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: CVPath Institute Inc.
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: Aloke V Finn, MD, CVPath Institute

Publications and helpful links

General 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.
• Schmidt 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.
• Lazar 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.
• 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.
• Kawakami 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2020
• Primary Completion (Actual): August 19, 2020
• Study Completion (Actual): August 19, 2020

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (Actual): October 18, 2019

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 16, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: CP2561-0316

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No