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Intraprocedural Intraaortic Embolic Protection With the EmbolX Device in Patients Undergoing Transaortic Transcatheter Aortic Valve Implantation

NCT01735513 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-05-12

No results posted yet for this study

Summary

Study hypothesis: Reduction of cerebral embolic lesions during transcatheter aortic valve implantation by the use of an embolic protection device.

Conditions

  • Transaortic Transcatheter Aortic Valve Implantation

Interventions

DEVICE

Intra-aortic embolic protection management system; Embol-X

The Embol-X system is positioned within the aorta to capture emboli, such as blood clots or tissue fragments, to prevent them from traveling through a patient's bloodstream during TAVI. The EMBOL-X system features a small, expandable, polyester-mesh filtration system that is placed inside the aorta above the aortic clamp during open-heart surgery or transaortic TAVI procedures, where it captures particles in the bloodstream that otherwise might have remained in the patient's circulatory system. A recent presentation characterized the removal of aortic cross-clamps as creating in some patients "embolic showers" which have the potential to cause neurocognitive complications, stroke and other organ damage. In documented procedures, 97% of EMBOL-X system filters showed detectable captured embolic matter, visible proof that the system is removing potentially dangerous emboli from the bloodstream.

Sponsors & Collaborators

  • University Hospital, Essen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-04-30
Completion
2015-09-30

Countries

  • Germany

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 NCT01735513 on ClinicalTrials.gov