On-pump Intraoperative Echocardiography

Not Applicable

Completed

• Conditions: Septal Myectomy
• Interventions: 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

• Registration Number: NCT03094325
• Lead Sponsor: NYU Langone Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-23
• Study First Submitted: 2017-03-23
• Study First Submitted QC: 2017-03-23
• Study First Posted: 2017-03-29
• Primary Completion: 2018-05-30
• Study Completion: 2018-11-23
• Results First Submitted: 2019-07-15
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-17
• Last Update Submitted: 2020-03-17
• Results First Posted: 2020-03-31
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• scheduled to receive a septal myectomy.

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Exclusion Criteria

• Less than 18 years of age

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Septal myectomy	Pre Operative Transesophageal echocardiography (TEE) imaging	-
Septal myectomy	Post Operative Transesophageal echocardiography (TEE) imaging	-
Septal myectomy	Pre Operative On-pump intraoperative echocardiography	-
Septal myectomy	Post Operative On-pump intraoperative echocardiography	-

Primary Outcome Measures

Name	Time	Method
Septal Thickness Measured Before Cardiopulmonary Bypass	1 Day	Center tendency parameters(mean, standard deviation)

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States