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On-pump Intraoperative Echocardiography (OPIE)

NYU Langone Health logo

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)

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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