On-pump Intraoperative Echocardiography

NCT ID: NCT03094325

Last Updated: 2020-03-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-23

Study Completion Date

2018-11-23

Brief Summary

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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

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Conditions

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Septal Myectomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Each of the 10 patients will have 4 measurements(OPIE \& TEE before cardiopulmonary bypass and OPIE \& TEE after cardiopulmonary bypass) in the septum using two techniques (TEE and OPIE Ultrasound Probe).

Study Groups

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Septal myectomy

Group Type EXPERIMENTAL

Pre Operative On-pump intraoperative echocardiography

Intervention Type DEVICE

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

Pre Operative Transesophageal echocardiography (TEE) imaging

Intervention Type DEVICE

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

Post Operative On-pump intraoperative echocardiography

Intervention Type DEVICE

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

Post Operative Transesophageal echocardiography (TEE) imaging

Intervention Type DEVICE

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

Interventions

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Pre Operative On-pump intraoperative echocardiography

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

Intervention Type DEVICE

Pre Operative Transesophageal echocardiography (TEE) imaging

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

Intervention Type DEVICE

Post Operative On-pump intraoperative echocardiography

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

Intervention Type DEVICE

Post Operative Transesophageal echocardiography (TEE) imaging

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

Intervention Type DEVICE

Other Intervention Names

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OPIE TEE

Eligibility Criteria

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Inclusion Criteria

* scheduled to receive a septal myectomy.

Exclusion Criteria

* Less than 18 years of age
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Swistel

Role: PRINCIPAL_INVESTIGATOR

New York University Medical Center Institutional Review Boards

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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16-01729

Identifier Type: -

Identifier Source: org_study_id

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