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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the conclusion of all data collection; approximately 6 to 12 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the conclusion of all data collection; approximately 6 to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the conclusion of all data collection; approximately 6 to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
correlations
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.
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,367 Previous Clinical Trials
839,701 Total Patients Enrolled
Daniel Swistel, MDPrincipal InvestigatorNYU Langone Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 and scheduled for heart surgery due to thickened heart muscle.I am over 18, have hypertrophic cardiomyopathy, and will have surgery to remove part of my heart muscle.
Research Study Groups:
This trial has the following groups:- Group 1: OPIE in thin inverventricular septum
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are enrolment applications being accepted for this investigation?
"The records on clinicaltrials.gov confirm that this trial is no longer recruiting participants, as the last update to it was dated August 8th 2022. Although, there are 168 other trials currently seeking volunteers."
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