CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Pre Operative On-pump intraoperative echocardiography +3 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03094325
NCT03094325N/ACompleted
CompareCT.gov

On-pump Intraoperative Echocardiography (OPIE)

NYU Langone Health·interventional·Posted Mar 29, 2017·Updated Mar 31, 2020

In Brief

A clinical study evaluating Pre Operative On-pump intraoperative echocardiography, Pre Operative Transesophageal echocardiography (TEE) imaging, and 2 other interventions for Septal Myectomy. Completed, enrolled 10 participants across 1 site.

Detailed Summary

This pilot study uses an ultrasound probe that is currently clinically used to assess pituitary anatomy, the Hitachi-Aloka high resolution pituitary transducer to measure left ventricular (LV) septal thickness during cardiopulmonary bypass in the performance of surgical septal myectomy. Septal thickness will be assessed and can be visualized during the procedure and if it is likely to improve the efficacy and safety of the procedure. The probe has FDA clearance for a variety of intra-operative surgical procedures but will be off-label for this cardiac surgical protocol.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeptal Myectomy
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 29, 2017
Enrollment StartMar 23, 2017
Primary CompletionMay 30, 2018
Study CompletionNov 23, 2018
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.3 years ago

Interventions

Pre Operative On-pump intraoperative echocardiographydevice

Center tendency parameters(mean, standard deviation) will be reported for each outcome.

Pre Operative Transesophageal echocardiography (TEE) imagingdevice

Center tendency parameters(mean, standard deviation) will be reported for each outcome.

Post Operative On-pump intraoperative echocardiographydevice

Center tendency parameters(mean, standard deviation) will be reported for each outcome.

Post Operative Transesophageal echocardiography (TEE) imagingdevice

Center tendency parameters(mean, standard deviation) will be reported for each outcome.