New procedure to reduce heart septum thickness in patients with LVOTO
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Early Feasibility Study
NA · National Institutes of Health Clinical Center (CC) · NCT06269640
This study is testing a new procedure to see if it can safely reduce heart septum thickness in adults with a condition that makes it hard for blood to flow from the heart.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 21 Years to 99 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) (nih) |
| Locations | 2 sites (Atlanta, Georgia and 1 other locations) |
| Trial ID | NCT06269640 on ClinicalTrials.gov |
What this trial studies
This study evaluates a novel procedure called Septal Scoring Along Midline Endocardium (SESAME) designed to treat left ventricular outflow tract obstruction (LVOTO) caused by thickening of the heart septum. The procedure involves using transcatheter electrosurgery to remove excess septal tissue in adults with symptomatic hypertrophic cardiomyopathy and other related conditions. Participants will undergo baseline assessments, including imaging and functional tests, before receiving the SESAME procedure, which requires a hospital stay of 2 to 6 days. The study aims to assess the safety and early feasibility of this innovative approach in a diverse patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 21 years and older with symptomatic hypertrophic cardiomyopathy and significant left ventricular outflow obstruction.
Not a fit: Patients who are not severely symptomatic or those who are not at high risk for surgical myectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this procedure could provide a less invasive treatment option for patients suffering from severe LVOTO, potentially improving their quality of life and reducing symptoms.
How similar studies have performed: While this approach is novel, it builds on existing techniques for septal reduction, and preliminary experiences with similar procedures suggest potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: * Adults age \>= 21 years * Requires debulking of left ventricular septum for hypertrophic cardiomyopathy * Septal diastolic thickness of obstructive hump on CT: * Total \>=16 mm, and * Predicted residual septal thickness \>= 8 mm, and * Predicted laceration depth \>= 6 mm * Severely symptomatic, any of * NYHA Class III or greater * Canadian Angina Class CCS III or greater * Explicitly chooses investigational SESAME over conventional treatment approaches including (1) cardiac myosin inhibitor therapy, if eligible; (2) transcoronary alcohol septal ablation, if eligible; or (3) surgical left ventricular myotomy and/or myectomy, if eligible * Concurrence of the multidisciplinary institutional heart team that the candidate is at high risk for surgical myectomy * Concurrence of the study Central Clinical Eligibility Committee * Willing to return for all scheduled follow-up activities, and eligible or able to undergo required protocol and testing EXCLUSION CRITERIA: * Does not consent to participate, or unable to consent to participate * Requires antegrade SESAME access (because of mechanical aortic valve) * Prior completed transcoronary alcohol septal ablation, or prior surgical myectomy * Pregnant * Hemodynamic instability or emergency procedure * eGFR \< 30 mL/min/1.73m\^2 * Survival despite successful procedure expected \< 12months
Where this trial is running
Atlanta, Georgia and 1 other locations
- Emory University Hospital — Atlanta, Georgia, United States (RECRUITING)
- St Francis Hospital and Heart Center — Roslyn, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Robert J Lederman, M.D. — National Heart, Lung, and Blood Institute (NHLBI)
- Study coordinator: Annette Stine, R.N.
- Email: stinea@nhlbi.nih.gov
- Phone: (301) 402-5558
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypertrophic Cardiomyopathy, Left Ventricular Septal Hypertrophy, Mitral Valve Disease, Aortic Valve Stenosis, transcatheter electrosurgery, transcatheter ventricular myotomy, Cardiac interventricular septal reduction