OPIE in the Thin Interventricular Septum

NCT04050579 | Withdrawn FDA Device

• 1 other identifier: s19-01180
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• correlations

  correlation between OPIE and traditional imaging methods

  at the conclusion of all data collection; approximately 6 to 12 months

Study Arms (1)

OPIE in thin inverventricular septum

OTHER

The Principal Investigator use the OPIE probe to measure the anterior basilar septal thickness. Myectomy will be performed and OPIE will be repeated.

Device: on-pump intracardiac echocardiography

Interventions

on-pump intracardiac echocardiography DEVICE

Subjects will be patients with hypertrophic cardiomyopathy with interventricular septae less than 2.0cm who are undergoing septal myectomy. The patients will have already had a number of preoperative transthoracic echocardiographs as part of their normal hypertrophic cardiomyopathy care. Before cardiopulmonary bypass, the basal anterior septal thickness will be measured by transesophageal echocardiograph as is performed in all septal myectomy procedures. The Principal Investigator will then use the OPIE probe to measure the anterior basilar septal thickness. Myectomy will be performed and OPIE will be repeated. The post-myectomy anterior basilar septal thickness will again be measured by transesophageal echocardiography.

OPIE in thin inverventricular septum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (1)

• Williams DM, Nampi RG, Saric M, Grossi EA, Sherrid MV, Swistel DG. A novel imaging modality to guide septal myectomy for hypertrophic cardiomyopathy. Podium presentation at the Western Thoracic Surgical Society Association Annual Meeting. Squaw Valley, CA. June 28, 2019.

  BACKGROUND

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Daniel Swistel, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 8, 2019
• Study Start: September 15, 2020
• Primary Completion: May 20, 2025
• Study Completion: May 30, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

Locations

US (1)