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DEFLECT II: A Study to Evaluate the Safety and Performance of the TriGuard™HDH in Patients Undergoing TAVR

NCT02073851 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2015-08-27

No results posted yet for this study

Summary

Pilot study enrolling up to 12 patients at a single investigational site in the Netherlands. Patients for TAVR will be enrolled to receive the Embolic Deflection Device throughout the duration of the TAVR procedure.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

TriGuard™HDH

TriGuard™HDH Embolic Deflection Device in patients undergoing Transcatheter Aortic Valve Replacement (TAVR)

Sponsors & Collaborators

  • Keystone Heart

    lead INDUSTRY

Principal Investigators

  • Pieter Stella, Md. · UMC Utrecht

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-08-31
Completion
2014-09-30

Countries

  • 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 NCT02073851 on ClinicalTrials.gov