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 range21 Years – 99 Years

SexALL

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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

What they're measuring

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)

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)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2024-12-23

Results submitted2025-11-14

View on ClinicalTrials.gov More Hypertrophic Cardiomyopathy trials