N/A N=10 Diagnostic

On-pump Intraoperative Echocardiography

Septal Myectomy

Bottom Line

View on ClinicalTrials.gov: NCT03094325 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2020

Primary outcome: Primary: Septal Thickness Measured Before Cardiopulmonary Bypass — 22.9; 22.5 millimeters

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: 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 (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: NYU Langone Health
Primary completion: May 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Septal Thickness Measured Before Cardiopulmonary Bypass	22.9; 22.5	—

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.

Eligibility Criteria

Inclusion Criteria

scheduled to receive a septal myectomy.

Exclusion Criteria

Less than 18 years of age

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03094325). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.