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Nitinol Circular Blade

NCT03881527 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-03-19

No results posted yet for this study

Summary

The Nitinol Circular Blade (NCB) is indicated for use in patients with symptomatic aortic stenosis requiring aortic valve replacement, who are going to be operated by conventional sternotomy with native valve resection and replacement by a prosthetic aortic valve. The resection of the diseased leaflets will be performed by the NCB rather than conventional surgical blade.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

Aortic valve replacement using a nitinol blade

A circular nitinol blade will be inserted by to cut the aortic valve leaflets during conventional aortic valve replacement procedure

PROCEDURE

aortic valve replacement

Aortic valve replacement in a standard fashion

Sponsors & Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    lead OTHER

Principal Investigators

  • Parla ASTARCI, Md PhD · Cliniques universiatires St Luc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Belgium

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 NCT03881527 on ClinicalTrials.gov