Hypertrophic CardiomyopathyNCT07806149
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
A study testing SESAME Procedure in people with Hypertrophic Cardiomyopathy and Left Ventricular Outflow Obstruction, run by National Heart, Lung, and Blood Institute (NHLBI) at 8 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction, Systolic Anterior Motion
- What is being tested?
- SESAME Procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 8 sitesUnited States
- Study dates
- 28 Oct 2026to 1 Mar 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age >= 21 years
- Requires left ventricular septal reduction therapy for one of two indications
- Obstructive hypertrophic cardiomyopathy with symptomatic left ventricular outflow tract obstruction (30mmHg peak while resting OR 50mmHg peak when provoked); OR
- 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:
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- 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
- cardiac myosin inhibitor therapy, if eligible (obstructive HCM only);
- transcoronary alcohol septal ablation, if eligible; or
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites
Emory University Hospital
Atlanta, Georgia, 30322
Vasilis Babaliaros, M.D., 678-557-4514
Adam B Greenbaum, M.D., (678) 557-4514, adam.b.greenbaum@emory.edu
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
James McCabe, M.D., 617-667-8800
Univ. of Virginia
Charlottesville, Virginia, 22908
John Saxon, M.D., 434-243-1000
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014
Jason Foerst, M.D., 540-982-8204, jrfoerst@carilionclinic.org
St. Francis Hospital & Heart Center
Roslyn, New York, 11576
Jaffar M Khan, M.D., 516-390-9640
Montefiore Medical Center: Einstein Campus
The Bronx, New York, 10461
Mohamed Azeem Latib, M.D., 718-920-4212
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Toby Rogers, M.D., 202-877-5975
WellSpan York Hospital
York, Pennsylvania, 17403
Christopher G Bruce, M.D., 717-851-2441
About this study
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).
Read more
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.
Read the detailed description
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.
- Conditions
- Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction, Systolic Anterior Motion
- Being tested
- SESAME Procedure
- Keywords
- Transcatheter Mitral Valve Replacement, transcatheter electrosurgery, Septal reduction therapy, Cardiac catheterization methods, Myosin inhibitors, Myectomy, Myotomy
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Ventricular Outflow Obstruction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SESAME ProcedureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| SESAME Arm | Experimental | The intervention is the SESAME procedure. Receives: Device: SESAME Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
SESAME Technical Success
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%.
Measured: Completion of SESAME procedure
SESAME Safety
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.
Measured: 30 days after SESAME procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start28 Oct 2026 (estimated)
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert J Lederman, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806149
- Sponsor's protocol ID
- 10002783
- Other IDs
- 002783-H
- Status last verified
- 11 Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes