On-pump Intraoperative Echocardiography (OPIE)

On-pump Intraoperative Echocardiography (OPIE)

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 Overview

• Status: Completed
• Conditions: Septal Myectomy
• Intervention / Treatment: Device: Pre Operative On-pump intraoperative echocardiography; Device: Pre Operative Transesophageal echocardiography (TEE) imaging; Device: Post Operative On-pump intraoperative echocardiography; Device: Post Operative Transesophageal echocardiography (TEE) imaging

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• scheduled to receive a septal myectomy.

Exclusion Criteria:

• Less than 18 years of age

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Septal myectomy

Device: Pre Operative On-pump intraoperative echocardiography; Center tendency parameters(mean, standard deviation) will be reported for each outcome.; Other Names: OPIE; Device: Pre Operative Transesophageal echocardiography (TEE) imaging; Center tendency parameters(mean, standard deviation) will be reported for each outcome.; Other Names: TEE; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Septal Thickness Measured Before Cardiopulmonary Bypass	Center tendency parameters(mean, standard deviation)	1 Day

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Daniel Swistel, New York University Medical Center Institutional Review Boards

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 23, 2017
• Primary Completion (ACTUAL): May 30, 2018
• Study Completion (ACTUAL): November 23, 2018

Study Registration Dates

• First Submitted: March 23, 2017
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (ACTUAL): March 29, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 31, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Septal Myectomy
• Other Study ID Numbers: 16-01729

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No