NCT04050579Withdrawn
OPIE in the Thin Interventricular Septum
A Single Center Trial of On-pump Intracardiac Echocardiography (OPIE) in the Thin Interventricular Septum
Source: ClinicalTrials.gov · Last updated 11 Jun 2025
Reason given: Study was determined to be focused on Quality Assurance (QA) and Quality Improvement (QI), rather than research, based on its primary purpose and activities. Study was closed prior to enrollment.
Brief summary (registry, in English)
This is a follow up investigation to our previous study entitled "On-pump intraoperative echocardiography (OPIE)" (clinicaltrials.gov NCT03094325) whereby we determined that left ventricular septal thickness as measured by the OPIE technique correlates highly with traditional methods of transthoracic and transesophageal echocardiography during septal myectomy for hypertrophic cardiomyopathy. OPIE may be especially useful in patients with a thin ventricular septal thickness as adequate treatment may rely on mere millimeters of myocardial resection. We therefore propose a study in which OPIE is compared to transthoracic and transesophageal echocardiography in patients with a thin interventricular septum. Subjects will receive the same perioperative care regardless of their involvement in the study. Patients who enroll in the study will undergo an additional intraoperative echocardiographic measurement that adds less than five minutes to total operative time.
- Status (registry)
- Withdrawn
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 6 Aug 2019
- Start date
- 15 Sept 2020
- Primary completion date
- 20 May 2025
- Lead sponsor
- NYU Langone Health
- Diseases
- Hypertrophic cardiomyopathy
- NCT number
- NCT04050579
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Those hypertrophic cardiomyopathy patients who are scheduled to receive a septal myectomy who are less than 18 years old or whose preoperative transthoracic echocardiograph suggests an interventricular septal width of greater than 2.0 cm.
Who the study is looking for
- All hypertrophic cardiomyopathy patients, inclusive of male and female and all racial/ethnic origins, age 18 or older who are scheduled to receive a septal myectomy with a preoperative transthoracic echocardiograph suggesting an interventricular septal width of less than 2.0 cm.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NYU Langone Health | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.