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NCT02389894 · ClinicalTrials.gov registry record · NA

Neuroprotection in Patients Undergoing Aortic Valve Replacement

A NA study, sponsored by Icahn School of Medicine at Mount Sinai.

Completed
Registry status
NA
Development phase
383
Enrollment target

NCT02389894: Completed NA study, sponsored by Icahn School of Medicine at Mount Sinai.

NCT02389894 is a NA study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 383 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02389894, a NA study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.

COMPLETED
Registry status
NA
Development phase
383 participants
Enrollment target

Study Summary

To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement (AVR).

Primary Outcome

freedom from CNS infarction, defined as brain, spinal cord, or retinal cell death attributable to ischemia based on neuropathological, neuroimaging, or clinical evidence of permanent injury based on symptoms persisting \> 24 hours, with overt symptoms or no known symptoms. All patients will be assessed by 1.5 T (3.0 T is acceptable if 1.5 T not available) Diffusion-weighted imaging (DWI) at 7 (± 3) days post procedure for presence of brain lesions and to measure the number and volume of any pres

Interventions

  • DEVICE Embol-X Embolic Protection Device
  • DEVICE CardioGard Cannula

Trial Details

FieldValue
Enrollment Target 383 participants
Start Date 2015-03
Est. Completion 2017-01
Phase NA

What the finished NCT02389894 record still lists

NCT02389894 is an interventional study that assigns participants to a tested intervention. The registered 383 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (73% lower).

The record links to 0 conditions, and to 2 interventions - of which Embol-X Embolic Protection Device is the first listed.

NCT02389894 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02389894 about?

NCT02389894 is a clinical study titled "Neuroprotection in Patients Undergoing Aortic Valve Replacement". To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement (AVR).

What is the current status of trial NCT02389894?

This trial is currently completed. It is a NA study. The enrollment target is 383 participants. The study started on 2015-03. Estimated completion is 2017-01.

What interventions are being tested in trial NCT02389894?

The interventions under investigation include: Embol-X Embolic Protection Device (DEVICE), CardioGard Cannula (DEVICE).

Who is sponsoring clinical trial NCT02389894?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02389894's enrollment target sits among peer trials

383 273rd of 2000 higher than 1,728 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02389894, the US trial registry maintained by the National Library of Medicine. NCT02389894 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.