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OpenTrials
Completed

NCT Number: NCT03094325

On-pump Intraoperative Echocardiography

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.

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Key information

Conditions

Septal Myectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • scheduled to receive a septal myectomy.

Exclusion criteria

  • Less than 18 years of age

Treatment and study plan

Pre Operative On-pump intraoperative echocardiography

Device

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

Other names: OPIE

Pre Operative Transesophageal echocardiography (TEE) imaging

Device

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

Other names: TEE

Post Operative On-pump intraoperative echocardiography

Device

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

Post Operative Transesophageal echocardiography (TEE) imaging

Device

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

Primary outcomes

  1. Septal Thickness Measured Before Cardiopulmonary Bypass

    Time frame: 1 Day

    Center tendency parameters(mean, standard deviation)

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

On-pump Intraoperative Echocardiography (OPIE)

Acronym: OPIE

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 29, 2017
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.