SESAME Procedure for Hypertrophic Cardiomyopathy

No longer recruiting at 1 trial location

Overseen By Annette M Stine, R.N.

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new procedure called Septal Scoring Along Midline Endocardium (SESAME) to treat a heart condition where the wall separating the heart's main pumping chambers thickens, reducing blood flow and causing symptoms like shortness of breath or chest pain. The procedure removes excess heart tissue to improve blood flow. People with severe symptoms who prefer this new method over traditional treatments might be suitable candidates. Participants will stay in the hospital for a few days and return for follow-ups. As an unphased trial, this study offers patients an opportunity to explore an innovative treatment option that may provide relief when traditional methods are not preferred.

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 prior data suggests that the SESAME procedure is safe for treating LVOTO?

Research has shown that the SESAME procedure, which involves removing extra tissue from the heart's septum, was tested on 54 patients with various heart conditions. This group included 47 patients who underwent the procedure before heart valve replacement, 6 patients with a type of heart muscle disease, and 1 patient with a membrane issue in the heart. These studies focused on assessing the procedure's safety and practicality.

Although specific side effects are not detailed in the sources, the procedure's application to different patient types suggests it has been generally well-tolerated. The procedure aims to improve blood flow by carefully removing thickened tissue that blocks the heart's outflow. Participants in these studies stayed in the hospital for observation and follow-up, a standard practice to ensure safety after such procedures.

For those considering this trial, it is important to know that the SESAME procedure is still under study for safety and effectiveness. However, past studies indicate it has been practical and generally safe for the types of patients involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The SESAME Procedure for hypertrophic cardiomyopathy is unique because it introduces a new technique called Septal Scoring Along Midline Endocardium. Unlike traditional treatments like medications or invasive surgical options such as myectomy, SESAME offers a less invasive approach by specifically targeting and reducing the thickened heart muscle that causes the condition. Researchers are excited because this method focuses on precision and aims to alleviate symptoms with potentially fewer risks and a quicker recovery time compared to more invasive procedures.

What evidence suggests that the SESAME procedure is effective for hypertrophic cardiomyopathy?

Research has shown that the SESAME procedure, which removes extra tissue from the heart's septum, can effectively relieve the blockage that reduces blood flow in patients with hypertrophic cardiomyopathy. In a study with 76 patients, the SESAME procedure successfully reduced the heart's obstruction. This method, similar to a surgical technique called myotomy, aims to ease symptoms caused by the thickened heart wall. Evidence from these studies suggests that SESAME may improve heart function and reduce symptoms like chest pain and shortness of breath for patients with this condition. Participants in this trial will receive the SESAME procedure to further evaluate its effectiveness. ^{1 3 4 5 6}

Who Is on the Research Team?

Robert J Lederman, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Are You a Good Fit for This Trial?

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

Pregnant

Survival despite successful procedure expected < 12months

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40828310/

septal scoring along the midline endocardium - PubMed - NIH Results: A total of 54 consecutive patients underwent SESAME at our institution: 47 prior to TMVR, 6 for oHCM, and 1 for a subaortic membrane.

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.121.011686

Transcatheter Myotomy to Relieve Left Ventricular Outflow ... This preclinical study demonstrated feasibility of SESAME, a novel transcatheter myotomy to relieve left ventricular outflow tract obstruction.

3. eurointervention.pcronline.com eurointervention.pcronline.com/article/sesame-technique-septal-scoring-along-the-midline-endocardium

SESAME technique: septal scoring along the midline ... Results: A total of 54 consecutive patients underwent SESAME at our institution: 47 prior to TMVR, 6 for oHCM, and 1 for a subaortic membrane. Technical success ...

4. jacc.org jacc.org/doi/10.1016/j.jacc.2024.02.007

Transcatheter Myotomy to Reduce Left Ventricular Outflow ... SESAME mimics surgical myotomy with the aim to score the midline septal myocardium, producing septal myocardial splay and reducing the ...

5. acc.org acc.org/Latest-in-Cardiology/Journal-Scans/2024/04/03/16/38/transcatheter-myotomy-to-reduce

Transcatheter Myotomy to Reduce LVOT Obstruction Results: In this single-center retrospective study between 2021–2023, 76 patients underwent SESAME. Eleven (14%) had classic hypertrophic ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06269640

NHLBI SESAME (SEptal Scoring Along Midline ... This study systematically characterizes the safety and early feasibility of SESAME at 2 enrolling site. SESAME is performed as septal reduction therapy in a ...