Septal Myectomy
Conditions
Keywords
Septal Myectomy
Brief summary
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.
Interventions
DEVICEPre Operative On-pump intraoperative echocardiography
Center tendency parameters(mean, standard deviation) will be reported for each outcome.
DEVICEPre Operative Transesophageal echocardiography (TEE) imaging
Center tendency parameters(mean, standard deviation) will be reported for each outcome.
DEVICEPost Operative On-pump intraoperative echocardiography
Center tendency parameters(mean, standard deviation) will be reported for each outcome.
DEVICEPost Operative Transesophageal echocardiography (TEE) imaging
Center tendency parameters(mean, standard deviation) will be reported for each outcome.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* scheduled to receive a septal myectomy.
Exclusion criteria
* Less than 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Septal Thickness Measured Before Cardiopulmonary Bypass | 1 Day | Center tendency parameters(mean, standard deviation) |
Countries
United States
Participant flow
Recruitment details
All patients, inclusive of male and female and all racial/ethnic origins, age 18 or older who are scheduled to receive a septal myectomy
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Septal Myectomy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Septal Thickness Measured Before Cardiopulmonary Bypass
Center tendency parameters(mean, standard deviation)
Time frame: 1 Day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TEE Measured Septal Thickness Before Cardiopulmonary Bypass | Septal Thickness Measured Before Cardiopulmonary Bypass | 22.9 millimeters | Standard Deviation 4.6 |
| OPIE Measured Thickness Before Cardiopulmonary Bypass | Septal Thickness Measured Before Cardiopulmonary Bypass | 22.5 millimeters | Standard Deviation 3.5 |