On-pump Intraoperative Echocardiography (OPIE)

NYU Langone Health

Status: Completed

Conditions: Septal Myectomy

Treatments: Device: Post Operative On-pump intraoperative echocardiography; Device: Post Operative Transesophageal echocardiography (TEE) imaging; Device: Pre Operative Transesophageal echocardiography (TEE) imaging; Device: Pre Operative On-pump intraoperative echocardiography

Study type: Interventional

Funder types: Other

Identifiers

NCT03094325

16-01729

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• scheduled to receive a septal myectomy.

Exclusion criteria

• Less than 18 years of age

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Septal myectomy

Experimental group

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