SESAME Procedure for Hypertrophic Cardiomyopathy

Recruiting at 1 trial location

Overseen By Robert J Lederman, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Disqualifiers: Pregnant, Hemodynamic instability, others

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

Compensation: Varies

Number of Visits: 3

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Background: Some people have a condition in which the wall (septum) that separates the two main pumping chambers of the heart is too thick. This thick septum causes a condition called "left ventricular outflow tract obstruction" (LVOTO), which reduces blood flow out of the heart. LVOTO can cause serious heart disease; symptoms may include shortness of breath, chest pain, heart failure, or death. Researchers want to find better ways to treat LVOTO. Objective: To test a new procedure where excess tissue is sliced away from the septum in people with LVOTO. This procedure is called "septal scoring along midline endocardium" (SESAME). Eligibility: Adults aged 21 years with LVOTO. Design: Participants will have baseline tests. They will have imaging scans and tests of their heart structure and function. They will take a walking test and answer questions about how their heart condition affects their life. Participants will stay in the hospital 2 to 6 days for the SESAME procedure. They will be completely or partially asleep for the procedure. A tube will be inserted into the mouth and down the throat to take pictures of the heart. Pictures may also be taken with a tube inserted inside the heart. Next, tubes will be inserted into the groin and guided through the blood vessels up to the heart. Guidewires will be inserted into the heart. Doctors will watch the path the wires take with x-rays and ultrasound. When the wire is in the correct place, it will be electrified to slice excess tissue away from the septum. Participants will have 3 follow-up visits within 1 year.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the SESAME treatment for hypertrophic cardiomyopathy?

The SESAME procedure is a new approach that mimics surgical myotomy, which is a known method to relieve obstruction in hypertrophic cardiomyopathy. While direct data on SESAME's effectiveness in humans is not provided, it is designed to address limitations of existing treatments like surgical myectomy and alcohol septal ablation, which have been used to treat similar conditions. ^{1 2 3 4 5}

What makes the SESAME treatment unique for hypertrophic cardiomyopathy?

The SESAME treatment is unique because it involves a novel approach called Septal Scoring Along Midline Endocardium, which is different from traditional surgical or medication-based treatments for hypertrophic cardiomyopathy. This method focuses on precisely scoring the heart's septum (the wall dividing the heart chambers) to reduce its thickness and improve heart function. ^{6 7 8 9 10}

Research Team

Robert J Lederman, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Eligibility Criteria

This trial is for adults aged 21 years and older with a heart condition where the wall between their heart's pumping chambers is too thick, causing reduced blood flow. Participants must be able to stay in the hospital for up to 6 days and commit to follow-up visits within a year.

Inclusion Criteria

I need a specific heart procedure due to severe symptoms or conditions.

I am 21 years old or older.

Exclusion Criteria

I do not agree or am unable to agree to join the study.

I have had a heart muscle reduction surgery or a similar procedure.

Pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Testing

Participants undergo baseline tests including imaging scans, heart structure and function tests, a walking test, and questionnaires about their heart condition

1-2 weeks

SESAME Procedure

Participants undergo the SESAME procedure, involving septal scoring along the midline endocardium to treat LVOTO

2-6 days

In-hospital stay

Follow-up

Participants have 3 follow-up visits within 1 year to monitor safety and effectiveness

1 year

3 visits (in-person)

Treatment Details

Interventions

• Septal Scoring Along Midline Endocardium

Trial Overview The study tests a new procedure called 'septal scoring along midline endocardium' (SESAME) designed to remove excess tissue from the septum of patients with left ventricular outflow tract obstruction, aiming to improve blood flow from the heart.

Participant Groups

Group I: SESAME Arm Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

Trials

3,987

Recruited

47,860,000+

Findings from Research

The SESAME procedure, a novel transcatheter myotomy technique, was successfully performed in 10 pigs, demonstrating its ability to increase left ventricular outflow tract area and relieve obstruction without causing significant complications.

While two naive pigs experienced ventricular septal defects due to deep lacerations, no defects occurred in pigs with induced hypertrophy, indicating that the procedure may be safer in patients with thicker septa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Myotomy to Relieve Left Ventricular Outflow Tract Obstruction: The Septal Scoring Along the Midline Endocardium Procedure in Animals. Khan, JM., Bruce, CG., Greenbaum, AB., et al.[2023]

Both alcohol septal ablation (ASA) and transaortic extended myectomy (TEM) significantly reduce midventricular pressure gradients and improve symptoms in patients with hypertrophic cardiomyopathy and midventricular obstruction, with follow-up showing substantial improvements in both groups.

TEM resulted in a greater reduction in pressure gradients compared to ASA, indicating it may be a more effective option for patients, as evidenced by a lower residual pressure gradient and a more significant decrease in symptoms of dyspnea and angina.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Alcohol Septal Ablation Versus Transaortic Extended Myectomy in Hypertrophic Cardiomyopathy with Midventricular Obstruction. Yang, YJ., Fan, CM., Yuan, JQ., et al.[2019]

In a study of 42 patients with hypertrophic cardiomyopathy (HCM), the severity of left ventricular hypertrophy was assessed using a scoring system, but no correlation was found between hypertrophy scores and patient symptoms or ECG abnormalities.

A significant relationship was identified between the severity of ventricular arrhythmias and hypertrophy scores, suggesting that high intraventricular pressures may contribute to arrhythmias by causing or worsening myocardial ischemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypertrophic cardiomyopathy: two-dimensional echocardiographic score versus clinical and electrocardiographic findings. Melacini, P., Fasoli, G., Canciani, B., et al.[2019]

In a study of 583 patients undergoing septal myectomy for hypertrophic cardiomyopathy, the procedure had a low early mortality rate of 1.9%, with the safest outcomes observed in isolated myectomy cases (0.8% mortality).

The study found that previous alcohol septal ablation significantly increased the risk of needing a pacemaker post-surgery (5.0% of patients), highlighting the importance of surgical technique and experience in ensuring patient safety and effective outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early post-septal myectomy outcomes for hypertrophic obstructive cardiomyopathy. Afanasyev, AV., Bogachev-Prokophiev, AV., Zheleznev, SI., et al.[2022]

In a study of 1,574 patients with obstructive hypertrophic cardiomyopathy, both surgical myectomy (SM) and alcohol septal ablation (ASA) showed similar mortality rates after a median follow-up of 1.3 years, indicating both treatments are equally safe in terms of survival.

However, patients who underwent ASA had a significantly lower risk of all-cause stroke compared to those who had SM, suggesting that ASA may offer additional benefits in reducing stroke risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Surgical Ventricular Septal Reduction to Alcohol Septal Ablation Therapy in Patients with Hypertrophic Cardiomyopathy. Bourque, C., Réant, P., Bernard, A., et al.[2022]

The updated GRACE risk score (2.0) was derived from a large cohort of 32,037 patients and shows improved accuracy in predicting short-term and long-term mortality and myocardial infarction in patients with acute coronary syndromes.

This new risk score utilizes non-linear algorithms for key predictors like age and blood pressure, enhancing its usability in clinical settings and making it easier to apply in emergency situations compared to the previous version.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Should patients with acute coronary disease be stratified for management according to their risk? Derivation, external validation and outcomes using the updated GRACE risk score. Fox, KA., Fitzgerald, G., Puymirat, E., et al.[2022]

The HEART score effectively predicts short-term major adverse cardiovascular events in both Caucasian and Asian patients, with similar performance across ethnic groups, as evaluated in a study of 3456 patients.

However, the incidence of events in the low-risk category was higher than previously reported, raising concerns about the safety of discharging patients classified as low risk based on the HEART score.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HEART score performance in Asian and Caucasian patients presenting to the emergency department with suspected acute coronary syndrome. de Hoog, VC., Lim, SH., Bank, IE., et al.[2022]

The study developed an automated system for scoring myocardial scar size using the Selvester QRS scoring system, specifically tailored for patients with left bundle branch block (LBBB), based on a dataset of 216 ECGs from the MADIT-CRT trial.

The automated scoring showed a high level of accuracy, with an average difference of only 1.2 points compared to expert manual scoring, indicating that this method could enhance clinical efficiency in assessing myocardial damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automatic QRS Selvester scoring system in patients with left bundle branch block. Xia, X., Wieslander, B., Strauss, DG., et al.[2019]

The myocardial area at risk (MaR) is crucial in acute ST-elevation myocardial infarction (STEMI) as it indicates the amount of heart tissue that could be saved with quick reperfusion therapy, but measuring it accurately can be challenging in clinical settings.

Combining the Aldrich ST score with the Selvester QRS score may improve the estimation of MaR during the acute phase of STEMI, as the Selvester QRS score provides additional information about infarcted myocardium that the Aldrich ST score alone may miss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consideration of QRS complex in addition to ST-segment abnormalities in the estimation of the "risk region" during acute anterior or inferior myocardial infarction. Vervaat, FE., Bouwmeester, S., van Hellemond, IE., et al.[2014]

The study identified three specific criteria from the Selvester 32-point QRS scoring system that can effectively screen for non-acute myocardial infarction (MI) with high specificity (95%) and good sensitivity (84% for inferior MI and 77% for anterior MI).

These criteria can accurately identify non-acute MI in about 80% of patients while only falsely indicating MI in 5% of normal subjects, making it a reliable tool for clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a QRS scoring system for estimating myocardial infarct size. VI: Identification of screening criteria for non-acute myocardial infarcts. Anderson, WD., Wagner, NB., Lee, KL., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Transcatheter Myotomy to Relieve Left Ventricular Outflow Tract Obstruction: The Septal Scoring Along the Midline Endocardium Procedure in Animals. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Alcohol Septal Ablation Versus Transaortic Extended Myectomy in Hypertrophic Cardiomyopathy with Midventricular Obstruction. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Hypertrophic cardiomyopathy: two-dimensional echocardiographic score versus clinical and electrocardiographic findings. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Early post-septal myectomy outcomes for hypertrophic obstructive cardiomyopathy. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Comparison of Surgical Ventricular Septal Reduction to Alcohol Septal Ablation Therapy in Patients with Hypertrophic Cardiomyopathy. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Should patients with acute coronary disease be stratified for management according to their risk? Derivation, external validation and outcomes using the updated GRACE risk score. [2022]

7. England pubmed.ncbi.nlm.nih.gov

HEART score performance in Asian and Caucasian patients presenting to the emergency department with suspected acute coronary syndrome. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Automatic QRS Selvester scoring system in patients with left bundle branch block. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Consideration of QRS complex in addition to ST-segment abnormalities in the estimation of the "risk region" during acute anterior or inferior myocardial infarction. [2014]

10. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a QRS scoring system for estimating myocardial infarct size. VI: Identification of screening criteria for non-acute myocardial infarcts. [2019]