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Procedure

SESAME Procedure for Hypertrophic Cardiomyopathy

N/A
Recruiting
Led By Robert J Lederman, M.D.
Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Requires debulking of left ventricular septum for one of three phenotypes: 1) Hypertrophic cardiomyopathy; 2) Left ventricular septal hypertrophy, mitral valve disease and/or aortic valve stenosis warranting/following transcatheter heart valve implantation, WITH intracameral gradient >= (30mmHg peak while resting; 50mmHg peak when provoked); 3) Left ventricular septal hypertrophy, mitral valve disease warranting transcatheter heart valve implantation, and risk of iatrogenic left ventricular outflow tract obstruction (LVOTO), Neo-LVOT <= 200 mm^2, WITHOUT intracameral gradient >= (30mmHg peak while resting; 50mmHg peak when provoked); Septal diastolic thickness on CT: Total >=12 mm, Predicted residual septal thickness >= 6 mm, 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 (HCM only); (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; Additional selection criteria for Hypertrophic Cardiomyopathy: High risk of surgical myotomy/myectomy according to the multidisciplinary heart team
Adults age >= 21 years
Must not have
Does not consent to participate, or unable to consent to participate
Prior completed transcoronary alcohol septal ablation, or prior surgical myectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up discharge
Awards & highlights
No Placebo-Only Group

Summary

"This trial is testing a new procedure called SESAME in adults with a condition where the heart's pumping chambers are separated by a thick wall. This thick wall can cause reduced blood flow and serious heart disease

Who is the study for?
This trial is for adults aged 21 years and older with a heart condition where the wall between their heart's pumping chambers is too thick, causing reduced blood flow. Participants must be able to stay in the hospital for up to 6 days and commit to follow-up visits within a year.
What is being tested?
The study tests a new procedure called 'septal scoring along midline endocardium' (SESAME) designed to remove excess tissue from the septum of patients with left ventricular outflow tract obstruction, aiming to improve blood flow from the heart.
What are the potential side effects?
Potential side effects may include complications related to anesthesia, risks associated with invasive procedures such as bleeding or infection at the insertion site, and possible damage to structures inside the heart.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need a specific heart procedure due to severe symptoms or conditions.
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I am 21 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not agree or am unable to agree to join the study.
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I have had a heart muscle reduction surgery or a similar procedure.
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I do not have unstable blood pressure or need emergency surgery.
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My kidney function is severely reduced.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety
Technical success
Secondary study objectives
Complete heart block requiring permanent pacemaker

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: SESAME ArmExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,936 Previous Clinical Trials
47,792,623 Total Patients Enrolled
11 Trials studying Aortic Valve Stenosis
1,885 Patients Enrolled for Aortic Valve Stenosis
Robert J Lederman, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
13 Previous Clinical Trials
875 Total Patients Enrolled
3 Trials studying Aortic Valve Stenosis
184 Patients Enrolled for Aortic Valve Stenosis
~20 spots leftby Oct 2026
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