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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Septal myectomy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre Operative On-pump intraoperative echocardiography | Device | Center tendency parameters(mean, standard deviation) will be reported for each outcome. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Septal Thickness Measured Before Cardiopulmonary Bypass | Center tendency parameters(mean, standard deviation) | 1 Day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Swistel | New York University Medical Center Institutional Review Boards | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
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All patients, inclusive of male and female and all racial/ethnic origins, age 18 or older who are scheduled to receive a septal myectomy
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| ID | Title | Description |
|---|---|---|
| FG000 | All Partcipants | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Septal Myectomy | Pre Operative On-pump intraoperative echocardiography: Center tendency parameters(mean, standard deviation) will be reported for each outcome. Pre Operative Transesophageal echocardiography (TEE) imaging: Center tendency parameters(mean, standard deviation) will be reported for each outcome. Post Operative On-pump intraoperative echocardiography: Center tendency parameters(mean, standard deviation) will be reported for each outcome. Post Operative Transesophageal echocardiography (TEE) imaging: Center tendency parameters(mean, standard deviation) will be reported for each outcome. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Septal Thickness Measured Before Cardiopulmonary Bypass | Center tendency parameters(mean, standard deviation) | Posted | Mean | Standard Deviation | millimeters | 1 Day |
|
1 year after cardiopulmonary bypass procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TEE Measured Septal Thickness Before Cardiopulmonary Bypass | Post Operative Transesophageal echocardiography (TEE) imaging: Center tendency parameters(mean, standard deviation) will be reported for each outcome. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Swistel, MD | NYU Langone Health | 646-754-7217 | Daniel.Swistel@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 6, 2016 | Jul 15, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017548 | Echocardiography, Transesophageal |
| D003952 | Diagnostic Imaging |
| ID | Term |
|---|---|
| D004452 | Echocardiography |
| D057791 | Cardiac Imaging Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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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).
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|
| Pre Operative Transesophageal echocardiography (TEE) imaging | Device | Center tendency parameters(mean, standard deviation) will be reported for each outcome. |
|
|
| 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. |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | OPIE Measured Thickness Before Cardiopulmonary Bypass | Post Operative On-pump intraoperative echocardiography: Center tendency parameters(mean, standard deviation) will be reported for each outcome | 0 | 10 | 0 | 10 | 0 | 10 |
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| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |