Sentinel Low Risk Registry

Aortic Valve Stenosis Clinical Trial

Official title:

Cerebral Protection of Acute Embolic Burden During Transcatheter Aortic Valve Implantation in Low Risk Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04131127
• Other study ID #: CP2561-0316
• Status: Completed
• Start date: January 7, 2020
• Est. completion date: August 19, 2020

Study information

• Verified date: October 2020
• Source: CVPath Institute Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 19, 2020
• Est. primary completion date: August 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• Sentinel Device
Sentinel Device used during TAVI in a Low Risk Patient

Locations

Country	Name	City	State
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Cleveland Clinic	Cleveland	Ohio
United States	Columbia University Medical Center	New York	New York
United States	UPMC Pinnacle	Wormleysburg	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
CVPath Institute Inc.	Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

Lazar RM, Pavol MA, Bormann T, Dwyer MG, Kraemer C, White R, Zivadinov R, Wertheimer JC, Thöne-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. — View Citation

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. — View Citation

Seeger J, Kapadia SR, Kodali S, Linke A, Wöhrle 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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