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PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement

NCT04149535 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2023-02-02

Study results available
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Summary

To demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of peri-procedural stroke (≤72 hours) after transcatheter aortic valve replacement (TAVR).

Conditions

Interventions

DEVICE

Sentinel® Cerebral Protection System

cerebral embolic protection system

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Samir Kapadia, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-07
Primary Completion
2022-02-01
Completion
2022-02-01
FDA Device
Yes

Countries

  • United States
  • Australia
  • Denmark
  • France
  • Germany
  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04149535 on ClinicalTrials.gov