Clinical trials terminated early due to trial feasibility
Sponsor study identifier
Secondary identifiers
interventional
1
1 country
1
Study Start
December 18, 2024
Actual (reported)Primary Completion
December 23, 2024
Actual (reported)Study Completion
December 23, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 23, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 17, 2024
Actual (reported)February 21, 2024
Actual (reported)December 18, 2024
Actual (reported)December 23, 2024
Actual (reported)December 23, 2024
Actual (reported)December 18, 2025
Actual (reported)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
Participants Undergoing SEptal Scoring Along Midline Endocardium (SESAME) Procedure that relies on intramyocardial guidewire navigation and transcatheter electrosurgery.
Transcatheter ventricular myotomy called SEptal Scoring Along the Midline Endocardium (SESAME) that relies on intramyocardial guidewire navigation and transcatheter electrosurgery
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Emory University Hospital
Atlanta, Georgia, 30322, United States
Robert J Lederman, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
1 participants (actual enrollment reported by the registry).
First Submitted
February 17, 2024
First Posted
February 21, 2024
Study Start
December 18, 2024
Actual (reported)Number of Complete Heart Block Events
Up to 4 Days
Contact the study team to confirm eligibility.
Primary Completion
December 23, 2024
Actual (reported)Study Completion
December 23, 2024
Actual (reported)Last Updated
December 18, 2025
Results First Posted
December 18, 2025
Record last verified: 2025-12
A peer-reviewed manuscript will constitute the clinical study report and shared data in Figshare after the manuscript is published.
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Source: ClinicalTrials.gov.
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