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On-pump Intraoperative Echocardiography

NCT03094325 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-03-31

Study results available
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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.

Conditions

  • Septal Myectomy

Interventions

DEVICE

Pre Operative On-pump intraoperative echocardiography

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

DEVICE

Pre Operative Transesophageal echocardiography (TEE) imaging

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

DEVICE

Post Operative On-pump intraoperative echocardiography

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

DEVICE

Post Operative Transesophageal echocardiography (TEE) imaging

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

Sponsors & Collaborators

Principal Investigators

  • Daniel Swistel · New York University Medical Center Institutional Review Boards

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-23
Primary Completion
2018-05-30
Completion
2018-11-23
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT03094325 on ClinicalTrials.gov