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Intracardiac Echocardiography for Hypertrophic Cardiomyopathy

N/A
Waitlist Available
Led By Daniel Swistel, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the conclusion of all data collection; approximately 6 to 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is investigating whether or not a new intraoperative echocardiography technique called OPIE is as effective as traditional methods in measuring the thickness of the left ventricular septum in patients with hypertrophic cardiomyopathy.

Who is the study for?
This trial is for adults over 18 with hypertrophic cardiomyopathy scheduled for septal myectomy and have a thin interventricular septum (less than 2.0 cm wide) as shown by echocardiography. It's open to all genders and races.
What is being tested?
The study tests on-pump intracardiac echocardiography (OPIE) against traditional transthoracic and transesophageal methods in measuring ventricular septal thickness during surgery for those with a thin septum.
What are the potential side effects?
There are no direct side effects from the OPIE procedure itself, as it involves additional imaging during an already-planned surgery, adding less than five minutes to the operation.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am under 18 and scheduled for heart surgery due to thickened heart muscle.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the conclusion of all data collection; approximately 6 to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the conclusion of all data collection; approximately 6 to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
correlations

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: OPIE in thin inverventricular septumExperimental Treatment1 Intervention
The Principal Investigator use the OPIE probe to measure the anterior basilar septal thickness. Myectomy will be performed and OPIE will be repeated.

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,407 Previous Clinical Trials
855,750 Total Patients Enrolled
Daniel Swistel, MDPrincipal InvestigatorNYU Langone Health

Media Library

OPIE in thin inverventricular septum Clinical Trial Eligibility Overview. Trial Name: NCT04050579 — N/A
Hypertrophic Cardiomyopathy Research Study Groups: OPIE in thin inverventricular septum
Hypertrophic Cardiomyopathy Clinical Trial 2023: OPIE in thin inverventricular septum Highlights & Side Effects. Trial Name: NCT04050579 — N/A
OPIE in thin inverventricular septum 2023 Treatment Timeline for Medical Study. Trial Name: NCT04050579 — N/A
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