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The REFLECT Trial: Cerebral Protection to Reduce Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation

NCT02536196 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 478

Last updated 2021-02-18

Study results available
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Summary

The Keystone Heart TriGuard™ HDH is an aortic embolism deflection device intended to reduce the amount of embolic material that may enter the carotid, subclavian, and vertebral arteries during transcatheter heart valve implantation.

The objective of the study is to assess the safety and efficacy of the TriGuard™ HDH embolic deflection device in patients undergoing transcatheter aortic valve implantation (TAVI), in comparison with an active control group of patients undergoing unprotected TAVI.

Subjects with indications for TAVI and who meet study eligibility criteria will be randomized 2:1 to one of two treatment arms: 1) Intervention: Embolic protection device (TriGuard™) with transcatheter aortic valve implantation or 2) Control: Unprotected transcatheter aortic valve implantation.

Conditions

  • Symptomatic Aortic Stenosis

Interventions

DEVICE

Embolic Protection Device

Embolic protection

PROCEDURE

Transcatheter aortic valve implantation (TAVI)

Transcatheter aortic valve implantation (TAVI)

Sponsors & Collaborators

  • Keystone Heart

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2019-05-31
Completion
2019-06-30

Countries

  • United States
  • Germany
  • Italy
  • Netherlands

Study Locations

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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 NCT02536196 on ClinicalTrials.gov