NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy · Left Ventricular Outflow Obstruction · Systolic Anterior Motion
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 21 años - 100 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 200 Estimado
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Acerca de la investigación
This is an early study of a catheter-based minimally invasive procedure called SESAME to slice thick heart muscle as described below.
Excessively-thick heart muscle can cause serious heart disease, especially heart failure with preserved ejection fraction, which causes shortness of breath and heart failure symptoms such as edema (swelling) and pulmonary congestion (lung water). Specific circumstances of excessively-thick heart muscle can block outflow of blood from the main heart pumping chamber (left ventricle).
We developed a catheter technique called SESAME (SEptal Scoring Along Midline Endocardium) to slice the excessively-thick heart muscle causing such problems. SESAME can be used in patients who have symptoms related to excessively-thick heart muscle in a part of the heart that restricts blood ejection from the heart; the problem is called "left ventricular outflow tract obstruction (LVOTO)." One group of patients who might benefit from SESAME suffer from a common inherited heart muscle disease called "hypertrophic cardiomyopathy (HCM)." Patients with HCM and symptoms from LVOTO can be treated with medications, open heart surgery, or catheter-based destruction of heart muscle in "alcohol septal ablation." If these treatments fail or are not suitable, then SESAME may be an option, because it resembles surgery treatment without open heart surgery.
Other groups of patients that might benefit are those with heart valve diseases, of the mitral or of the aortic valve, or both, along with excessively-thick heart muscle. These patients may be poor candidates for standard surgical valve repair or replacement because of high risk of complications or death. Such patients might be eligible for non-surgical transcatheter mitral valve replacement, either standard or unapproved ("off-label") or research ("investigational"), but are poor candidates because of risk of LVOTO. Moreover, about half have LVOTO making heart valve symptoms worse. Treating the LVOTO alone may improve symptoms enough that heart valve treatment can be delayed or avoided.
This is a sponsor-investigator IDE study of SESAME performed at a small number of centers that have adopted the technique in the practice of medicine, in order better to characterize how well it works and whether it is safe.
Participating centers already perform SESAME in the practice of medicine using improvised, off-label devices. This protocol allows prospective oversight, standardized technique constraints, central imaging review, independent monitoring, and formal safety adjudication. In addition, the investigational protocol does not function as the gatekeeper for access to SESAME.
The investigators are not affiliated with the guidewire manufacturer and do not seek marketing approval or clearance for SESAME.
Leer la descripción completa
Cardiac septal reduction therapies - to relieve left ventricular outflow tract obstruction from transcatheter mitral valve replacement or hypertrophic cardiomyopathy - have inherent limitations including dependence on coronary anatomy, high pacemaker implantation rate, and surgical morbidity. We developed a novel transcatheter ventricular myotomy called SEptal Scoring Along the Midline Endocardium (SESAME) that relies on intramyocardial guidewire navigation and transcatheter electrosurgery. SESAME has been performed on hundreds of patients worldwide using improvised (off-label and bedside-modified commercially available) devices. Recent benchtop refinements in SESAME technique, using improvised devices, are predicted to reduce the likelihood of serious complications such as ventricular perforation, iatrogenic ventricular septal defect, and death.
This sponsor-investigator IDE study systematically characterizes the safety and outcomes of SESAME at up to 10 enrolling sites. SESAME is performed as septal reduction therapy in a heterogeneous group of participants, including (1) symptomatic hypertrophic cardiomyopathy with resting or provoked left ventricular outflow obstruction (LVOTO); and (2) severe symptomatic mitral valve disease at high risk of standard heart surgical therapy and requiring later transcatheter mitral valve implantation combined with manifest or potential LVOTO. This study attempts to capture generalizable knowledge from as many patients as possible who undergo SESAME, and to add a limited number of research procedures to characterize the safety and provisional effectiveness of SESAME.
Participating centers already perform SESAME in the practice of medicine using improvised, off-label devices. This protocol allows prospective oversight, standardized technique constraints, central imaging review, independent monitoring, and formal safety adjudication. In addition, the investigational protocol does not function as the gatekeeper for access to SESAME.
The investigators are not affiliated with the guidewire manufacturer and do not seek marketing approval or clearance for SESAME.
¿Quién podría participar?
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- INCLUSION CRITERIA
- Adults age \>= 21 years
- Requires left ventricular septal reduction therapy for one of two indications
1. Obstructive hypertrophic cardiomyopathy with symptomatic left ventricular outflow tract obstruction (30mmHg peak while resting OR 50mmHg peak when provoked); OR
2. Planned transcatheter mitral valve replacement is feasible but limited by risk for iatrogenic left ventricular outflow tract obstruction, defined on contrast-enhanced CT as skirt-neo-LVOT \<200\^2
* Planning to undergo SESAME transcatheter myotomy
* Septal diastolic thickness on CT as measured by the NHLBI central laboratory before enrollment:
- For obstructive hypertrophic cardiomyopathy, \>=14mm;
- For transcatheter heart valve replacement, \>=12mm
and
- Intended minimum diastolic residual septal thickness \>=6mm
-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 (obstructive HCM only);
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 and that SESAME is an appropriate septal reduction strategy for this candidate.
* 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
- Pregnant
- Hemodynamic instability or emergency procedure
- Mechanical aortic valve
- eGFR \< 30 mL/min/1.73m\^2
Tratamiento, grupos y participación
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- Asignación
- Sin asignación al azar
- Enmascaramiento
- Sin enmascaramiento
SESAME Arm
The intervention is the SESAME procedure.
Device: SESAME Procedure
SESAME Procedure DEVICE
The intervention is the SESAME procedure, a catheter-based septal myotomy performed in adults with symptomatic or high-risk LVOT obstruction. It uses off-label Astato XS 20/40 guidewires and the NHLBI LCI electrosurgery timing appliance to create a controlled longitudinal laceration through the hypertrophied interventricular septum under fluoroscopic and echocardiographic guidance, with energy delivery limited to short pulses and cooling intervals to reduce thermal injury; all participants receive the same procedure, with follow-up assessments afterward.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
SESAME Technical Success
Plazo: Completion of SESAME procedure
The primary outcome is technical success, defined as the participant being alive and having a successful SESAME laceration, with post-procedure CT showing that the achieved minimum residual septal thickness matches the planned thickness within 20%.
SESAME Safety
Plazo: 30 days after SESAME procedure
The primary safety endpoint is freedom at 30 days from all-cause mortality, any stroke (disabling or non-disabling), and major SESAME-related cardiac structural complications requiring intervention, such as iatrogenic ventricular septal defect, aortic or mitral regurgitation, tamponade, or new permanent pacemaker implantation.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (8)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
8 centros
MedStar Washington Hospital CenterWashington D.C., District of Columbia, United StatesEstado desconocido
Emory University HospitalAtlanta, Georgia, United StatesEstado desconocido
Beth Israel Deaconess Medical CenterBoston, Massachusetts, United StatesEstado desconocido
St. Francis Hospital & Heart CenterRoslyn, New York, United StatesEstado desconocido
Montefiore Medical Center: Einstein CampusThe Bronx, New York, United StatesEstado desconocido
WellSpan York HospitalYork, Pennsylvania, United StatesEstado desconocido
Univ. of VirginiaCharlottesville, Virginia, United StatesEstado desconocido
Carilion Roanoke Memorial HospitalRoanoke, Virginia, United StatesEstado desconocido
Equipo y fechas
- Patrocinador principal
- National Heart, Lung, and Blood Institute (NHLBI)
- Inicio del estudio
- 15 nov 2026 Estimado
- Finalización primaria
- 1 mar 2029 Estimado
- Finalización del estudio
- 1 mar 2030 Estimado
- Primera publicación
- 8 sept 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026