Hypertrophic CardiomyopathyNCT06269640
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Early Feasibility Study
A study testing Septal Scoring Along Midline Endocardium in people with Hypertrophic Cardiomyopathy and Left Ventricular Septal Hypertrophy, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy, Left Ventricular Septal Hypertrophy, Mitral Valve Disease
- What is being tested?
- Septal Scoring Along Midline Endocardium
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2024to 23 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
Cardiac interventricular septal reduction therapies - to relieve left ventricular outflow tract obstruction from transcatheter valve replacement or hypertrophic cardiomyopathy - have inherent limitations including dependence on coronary anatomy, high pacemaker implantation rate, and surgical morbidity. We developed a novel transcatheter ventricular myotomy called SEptal Scoring Along the Midline Endocardium (SESAME) that relies on intramyocardial guidewire navigation and transcatheter electrosurgery. SESAME has been performed on a small number of patients using off label devices.
This study systematically characterizes the safety and early feasibility of SESAME at 2 enrolling site. SESAME is performed as septal reduction therapy in a heterogeneous group of subjects, including symptomatic hypertrophic cardiomyopathy and resting or provoked left ventricular outflow obstruction (LVOTO); and severe symptomatic mitral and/or aortic valve disease at high risk of standard heart surgical therapy and requiring later transcatheter heart valve implantation combined with manifest or potential LVOTO.
A key goal of this study is to attempt to capture generalizable knowledge from as many patients as possible, and to add a limited number of research procedures to characterize the safety and provisional effectiveness of SESAME. Absent realistic non-clinical models of HCM or LVH combined with aortomitral disease, we believe little more information can be gleaned without clinical investigation.
This protocol was revised to add a second enrolling medical center, and to focus inclusion criteria on research participants with hypertrophic cardiomyopathy (HCM). This protocol was further revised after the first subject died as a result of excessively-deep SESAME laceration. The required septal thickness for eligibility was increased from >=12mm to >=16mm.
- Conditions
- Hypertrophic Cardiomyopathy, Left Ventricular Septal Hypertrophy, Mitral Valve Disease, Aortic Valve Stenosis
- Being tested
- Septal Scoring Along Midline Endocardium
- Keywords
- transcatheter electrosurgery, transcatheter ventricular myotomy, Cardiac interventricular septal reduction
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Septal Scoring Along Midline EndocardiumDevice
Transcatheter ventricular myotomy called SEptal Scoring Along the Midline Endocardium (SESAME) that relies on intramyocardial guidewire navigation and transcatheter electrosurgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Septal Scoring Along Midline Endocardium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: Up to 4 days
Secondary outcomes (1)
Number of Complete Heart Block Events
Number of Complete heart block events requiring permanent pacemaker included in cardiac arrest
Measured: Up to 4 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start18 Dec 2024
- Primary completion23 Dec 2024
- Study completion23 Dec 2024
Why it stopped: Clinical trials terminated early due to trial feasibility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert J Lederman, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269640
- Sponsor's protocol ID
- 10001640
- Other IDs
- 001640-H
- Status last verified
- Dec 2025
- First submitted
- 17 Feb 2024
- Last updated
- 18 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: A peer-reviewed manuscript will constitute the clinical study report and shared data in Figshare after the manuscript is published.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Early Feasibility Study
- ClinicalTrials.gov ID
- NCT06269640
- Acronym / sponsor ID
- 10001640
- Conditions
- Hypertrophic Cardiomyopathy, Left Ventricular Septal Hypertrophy, Mitral Valve Disease, Aortic Valve Stenosis
- Keywords
- transcatheter electrosurgery, transcatheter ventricular myotomy, Cardiac interventricular septal reduction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Clinical trials terminated early due to trial feasibility
- Enrolment
- 1 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- 23 Dec 2024 (actual)
- First posted
- 21 Feb 2024 (actual)
- Results
- Posted 18 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cardiac interventricular septal reduction therapies - to relieve left ventricular outflow tract obstruction from transcatheter valve replacement or hypertrophic cardiomyopathy - have inherent limitations including dependence on coronary anatomy, high pacemaker implantation rate, and surgical morbidity. We developed a novel transcatheter ventricular myotomy called SEptal Scoring Along the Midline Endocardium (SESAME) that relies on intramyocardial guidewire navigation and transcatheter electrosurgery. SESAME has been performed on a small number of patients using off label devices.
This study systematically characterizes the safety and early feasibility of SESAME at 2 enrolling site. SESAME is performed as septal reduction therapy in a heterogeneous group of subjects, including symptomatic hypertrophic cardiomyopathy and resting or provoked left ventricular outflow obstruction (LVOTO); and severe symptomatic mitral and/or aortic valve disease at high risk of standard heart surgical therapy and requiring later transcatheter heart valve implantation combined with manifest or potential LVOTO.
A key goal of this study is to attempt to capture generalizable knowledge from as many patients as possible, and to add a limited number of research procedures to characterize the safety and provisional effectiveness of SESAME. Absent realistic non-clinical models of HCM or LVH combined with aortomitral disease, we believe little more information can be gleaned without clinical investigation.
This protocol was revised to add a second enrolling medical center, and to focus inclusion criteria on research participants with hypertrophic cardiomyopathy (HCM). This protocol was further revised after the first subject died as a result of excessively-deep SESAME laceration. The required septal thickness for eligibility was increased from >=12mm to >=16mm.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Undergoing SEptal Scoring Along Midline Endocardium (SESAME) Procedure | Experimental | Device: Septal Scoring Along Midline EndocardiumParticipants Undergoing SEptal Scoring Along Midline Endocardium (SESAME) Procedure that relies on intramyocardial guidewire navigation and transcatheter electrosurgery. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adults age >= 21 years
- Requires debulking of left ventricular septum for hypertrophic cardiomyopathy
- Septal diastolic thickness of obstructive hump on CT:
- Severely symptomatic, any of
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Septal Scoring Along Midline EndocardiumTranscatheter ventricular myotomy called SEptal Scoring Along the Midline Endocardium (SESAME) that relies on intramyocardial guidewire navigation and transcatheter electrosurgery | Device | Participants Undergoing SEptal Scoring Along Midline Endocardium (SESAME) Procedure |
Primary outcome
Number of Participant That Experienced Technical Success With the SESAME (SEptal Scoring Along Midline Endocardium)
Time frame: 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
Number of Inpatient Safety Events Related to SESAME (SEptal Scoring Along Midline Endocardium)
Time frame: 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).
1 secondary outcome
Number of Complete Heart Block Events
Time frame: Up to 4 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. A peer-reviewed manuscript will constitute the clinical study report and shared data in Figshare after the manuscript is published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J Lederman, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Septal Scoring Along Midline Endocardium in people with Hypertrophic Cardiomyopathy and Left Ventricular Septal Hypertrophy, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participant That Experienced Technical Success With the SESAME (SEptal Scoring Along Midline Endocardium) (time frame: 1 minute following procedure discharge (Exit from the catheterization laboratory)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.