NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Early Feasibility Study

NCT06269640 | Terminated Results DMC FDA Device

• 2 other identifiers: 10001640001640-H
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mitral Valve Disease; Aortic Valve Stenosis; Left Ventricular Septal Hypertrophy; Hypertrophic Cardiomyopathy

Keywords

transcatheter electrosurgery; transcatheter ventricular myotomy; Cardiac interventricular septal reduction

Outcome Measures

Primary Outcomes (2)

• Number of Participant That Experienced Technical Success With the SESAME (SEptal Scoring Along Midline Endocardium)

  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

  1 minute following procedure discharge (Exit from the catheterization laboratory)

• Number of Inpatient Safety Events Related to SESAME (SEptal Scoring Along Midline Endocardium)

  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).

  Up to 4 days

Secondary Outcomes (1)

• Number of Complete Heart Block Events

  Up to 4 Days

Study Arms (1)

Participants Undergoing SEptal Scoring Along Midline Endocardium (SESAME) Procedure

EXPERIMENTAL

Participants Undergoing SEptal Scoring Along Midline Endocardium (SESAME) Procedure that relies on intramyocardial guidewire navigation and transcatheter electrosurgery.

Device: Septal Scoring Along Midline Endocardium

Interventions

Septal Scoring Along Midline Endocardium DEVICE

Transcatheter ventricular myotomy called SEptal Scoring Along the Midline Endocardium (SESAME) that relies on intramyocardial guidewire navigation and transcatheter electrosurgery

Participants Undergoing SEptal Scoring Along Midline Endocardium (SESAME) Procedure

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction

Results Point of Contact

• Title: Robert Lederman, M.D.
• Organization: National Heart Lung and Blood Institute

lederman@nih.gov

301.402.6769

Study Officials

• Robert J Lederman, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2024
• First Posted: February 21, 2024
• Study Start: December 18, 2024
• Primary Completion: December 23, 2024
• Study Completion: December 23, 2024
• Last Updated: December 18, 2025
• Results First Posted: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Upon acceptance of the peer-reviewed manuscript.
• Access Criteria: unrestricted

Locations

US (1)