NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Early Feasibility Study (NCT06269640) | Clinical Trial Compass
TerminatedNot Applicable
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Early Feasibility Study
Stopped: Clinical trials terminated early due to trial feasibility
United States1 participantsStarted 2024-12-18
Plain-language 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.
Who can participate
Age range
21 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
* 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
EXCLUSION CRITERIA:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participant That Experienced Technical Success With the SESAME (SEptal Scoring Along Midline Endocardium)
Timeframe: 1 minute following procedure discharge (Exit from the catheterization laboratory)
2
Number of Inpatient Safety Events Related to SESAME (SEptal Scoring Along Midline Endocardium)
Timeframe: Up to 4 days
Trial details
NCT IDNCT06269640
SponsorNational Heart, Lung, and Blood Institute (NHLBI)