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The PROTEMBO C Trial

NCT04618718 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-05-08

Study results available
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Summary

The PROTEMBO C Trial is an international, multi-center, single arm, non-inferiority study of the safety and performance of using the ProtEmbo System for cerebral embolic protection in subjects with severe native aortic valve stenosis indicated for TAVR.

Conditions

  • Valvular Heart Disease

Interventions

DEVICE

cerebral embolic protection during TAVR

The ProtEmbo system is an adjunctive device placed in the central arterial system at the beginning of a TAVR procedure to deflect embolic particles during the procedure and removed following the completion of the procedure.

Sponsors & Collaborators

  • Avania

    collaborator INDUSTRY

  • Protembis GmbH

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-31
Primary Completion
2022-11-23
Completion
2022-11-23

Countries

  • Germany
  • Latvia
  • Poland

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 NCT04618718 on ClinicalTrials.gov