Adults 21 to 99, any sex, with Hypertrophic Cardiomyopathy or Left Ventricular Septal Hypertrophy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participant That Experienced Technical Success With the SESAME (SEptal Scoring Along Midline Endocardium)Primary· 1 minute following procedure discharge (Exit from the catheterization laboratory)
The primary feasibility endpoint is Technical success with the SESAME (SEptal Scoring Along Midline Endocardium) technique.
All of the following must be present:
* Alive
* Procedure success including
* Successful myocardial entry, navigation, and snaring of guidewire traversal system; and
* Successful laceration of septal myocardium
Group
Value
95% CI
Participants Undergoing SEptal Scoring Along Midline Endocardium (SESAME) Procedure
1
Number of Inpatient Safety Events Related to SESAME (SEptal Scoring Along Midline Endocardium)Primary· Up to 4 days
Number of Inpatient Safety Events related to SESAME (SEptal Scoring Along Midline Endocardium)
Safety is measured as freedom from all of the following:
* All-cause mortality
* All stroke (disabling and non-disabling)
* Major cardiac structural complication requiring intervention (such as iatrogenic ventricular septal defect, iatrogenic aortic valve regurgitation, iatrogenic mitral regurgitation, or pericardial tamponade).
Group
Value
95% CI
Participants Undergoing SEptal Scoring Along Midline Endocardium (SESAME) Procedure
2
Number of Complete Heart Block EventsSecondary· Up to 4 Days
Number of Complete heart block events requiring permanent pacemaker included in cardiac arrest
Group
Value
95% CI
Participants Undergoing SEptal Scoring Along Midline Endocardium (SESAME) Procedure
1
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 4 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Participants Undergoing SEptal Scoring Along Midline Endocardium (SESAME) Procedure
Background:
Some people have a condition in which the wall (septum) that separates the two main pumping chambers of the heart is too thick. This thick septum causes a condition called "left ventricular outflow tract obstruction" (LVOTO), which reduces blood flow out of the heart. LVOTO can cause serious heart disease; symptoms may include shortness of breath, chest pain, heart failure, or death. Researchers want to find better ways to treat LVOTO.
Objective:
To test a new procedure where excess tissue is sliced away from the septum in people with LVOTO. This procedure is called "septal scoring along midline endocardium" (SESAME).
Eligibility:
Adults aged 21 years with LVOTO.
Design:
Participants will have baseline tests. They will have imaging scans and tests of their heart structure and function. They will take a walking test and answer questions about how their heart condition affects their life.
Participants will stay in the hospital 2 to 6 days for the SESAME procedure.
They will be completely or partially asleep for the procedure. A tube will be inserted into the mouth and down the throat to take pictures of the heart. Pictures may also be taken with a tube inserted inside the heart.
Next, tubes will be inserted into the groin and guided through the blood vessels up to the heart. Guidewires will be inserted into the heart. Doctors will watch the path the wires take with x-rays and ultrasound. When the wire is in the correct place, it will be electrified to slice excess tissue away from the septum.
Participants will have 3 follow-up visits within 1 year.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI)
Last refreshed: 18 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06269640.