Intracardiac Echocardiography for Hypertrophic Cardiomyopathy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Age under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Less than 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special heart imaging technique, called on-pump intracardiac echocardiography (OPIE), measures heart muscle thickness more effectively than traditional methods. The focus is on patients with hypertrophic cardiomyopathy, a condition where the heart muscle thickens, particularly those with a very thin heart wall. Eligible participants are those scheduled for heart surgery with a heart wall thickness of less than 2.0 cm, as indicated by a pre-surgery heart ultrasound. During their operation, participants will receive an additional quick heart measurement, taking less than five minutes. As an unphased trial, this study offers a unique opportunity to advance heart imaging techniques for improved diagnosis and treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this intracardiac echocardiography technique is safe for patients with hypertrophic cardiomyopathy?

Research has shown that on-pump intracardiac echocardiography during surgery for hypertrophic cardiomyopathy is safe. Previous studies suggest that patients tolerate this technique well, with no significant long-term negative effects reported. This method adds a brief step to the surgery, taking less than five extra minutes. Overall, the safety data is reassuring, indicating that the procedure does not cause serious complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using on-pump intracardiac echocardiography (OPIE) for hypertrophic cardiomyopathy because it offers a real-time view inside the heart. Unlike traditional imaging techniques, which can be less precise during surgery, OPIE allows surgeons to measure the thickness of the heart's septum directly and accurately. This can improve the precision of a myectomy, a procedure to remove excess heart muscle. By providing detailed images during surgery, OPIE has the potential to enhance surgical outcomes and reduce the risk of complications.

What evidence suggests that intracardiac echocardiography is effective for hypertrophic cardiomyopathy?

This trial will evaluate the use of on-pump intracardiac echocardiography (OPIE) for patients with hypertrophic cardiomyopathy. Studies have shown that OPIE provides clear images during septal myectomy, a surgery for treating thickened heart muscle. This technique complements traditional imaging methods, such as those performed through the chest or esophagus. Specifically, patients with a heart wall thickness of 2.0 cm or less have benefited from the detailed images OPIE provides. It aids surgeons in making precise cuts by showing real-time images, which is crucial when only small amounts of heart tissue need removal. Although more research is needed, early results suggest that OPIE may improve surgical success by increasing accuracy. ^{6 7 8 9 10}

Who Is on the Research Team?

Daniel Swistel, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am over 18, have hypertrophic cardiomyopathy, and will have surgery to remove part of my heart muscle.

Exclusion Criteria

I am under 18 and scheduled for heart surgery due to thickened heart muscle.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo intraoperative echocardiographic measurement using the OPIE technique during septal myectomy

Less than 1 week

1 visit (in-person, intraoperative)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 to 12 months

What Are the Treatments Tested in This Trial?

Interventions

• On-pump Intracardiac Echocardiography

Trial Overview 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.

How Is the Trial Designed?

Group I: OPIE in thin inverventricular septum Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8298854/

On-pump intracardiac echocardiography during septal ... On-pump intracardiac echocardiography correlates with established imaging to aid in septal myectomy. Further studies are needed to examine the clinical ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S266625072500464X

Precision Myectomy: Real-Time On-Pump Intracardiac ... We retrospectively reviewed patients with hypertrophic cardiomyopathy and septal thickness ≤2.0 cm on transthoracic echocardiography (TTE) ...

3. researchgate.net researchgate.net/publication/339516081_On-pump_intracardiac_echocardiography_during_septal_myectomy_for_hypertrophic_cardiomyopathy

On-pump intracardiac echocardiography during septal ... PDF | On Feb 1, 2020, David M. Williams and others published On-pump intracardiac echocardiography during septal myectomy for hypertrophic cardiomyopathy ...

4. omicsdi.org omicsdi.org/dataset/biostudies-literature/S-EPMC8298854

S-EPMC8298854 - On-pump intracardiac echocardiography ... Septal Myectomy Outcomes in Children and Adolescents With Obstructive Hypertrophic Cardiomyopathy. Project description:BackgroundLittle data exist regarding ...

5. jacc.org jacc.org/doi/10.1016/j.jacc.2022.03.332

Surgical Septal Myectomy and Alcohol Ablation Cui et al 1 have shown better survival after surgical myectomy than after alcohol ablation in a large combined cohort of patients with obstructive hypertrophic ...

6. ahajournals.org ahajournals.org/doi/pdf/10.1161/JAHA.120.019419?download=true

Indications for Surgery in Obstructive Hypertrophic ... ... cardiac surgery □ hypertrophic cardiomyopathy □ outcomes ... On-pump intracardiac echocardiography during septal myectomy for hypertrophic cardiomyopathy.

7. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.124.014023?doi=10.1161/CIRCINTERVENTIONS.124.014023

Medical, Surgical, and Interventional Management of ... Hypertrophic cardiomyopathy is a common but underrecognized cardiac disorder characterized by a heterogenous phenotype that includes ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8267310/

A modified endocardial radiofrequency ablation approach ... Hypertrophic cardiomyopathy has a prevalence of approximately 1/500, and the prevalence of obstruction may be as high as 70% with provocation maneuvers (2). It ...

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/ehf2.14272

Alcohol septal ablation in hypertrophic cardiomyopathy: ... This was evaluated by a cardiomyopathy questionnaire; the study also showed no significant long-term treatment-related adverse events (median ...

10. jacc.org jacc.org/doi/10.1016/j.jacc.2023.05.052

First-in-Human Transapical Beating-Heart Septal ... - JACC BMD · beating-heart myectomy device ; CMR · cardiac magnetic resonance ; CPB · cardiopulmonary bypass ; HOCM · hypertrophic obstructive cardiomyopathy.