NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Not applicable

Age range

21 years - 100 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

200 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

• 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

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not randomized

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (8)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

8 locations

Study team and timeline

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Study start

Nov 15, 2026 Estimated

Primary completion

Mar 1, 2029 Estimated

Study completion

Mar 1, 2030 Estimated

First posted

Sep 8, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts