NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Early Feasibility Study

Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · Feb 20, 2024

Keywords

ClinConnect Summary

The NHLBI SESAME trial is studying a new procedure designed to help people with a heart condition called left ventricular outflow tract obstruction (LVOTO), which occurs when the wall between the heart's main pumping chambers becomes too thick. This thickening can make it hard for blood to flow from the heart and can lead to serious health issues, such as shortness of breath and chest pain. The trial aims to see if a technique called "septal scoring" can safely remove some of this excess tissue, improving blood flow and overall heart health.

To participate in the study, individuals must be at least 21 years old and have symptoms related to LVOTO, such as severe shortness of breath or chest pain. Eligible participants will stay in the hospital for 2 to 6 days for the procedure, where they will be given anesthesia to ensure comfort. Using special tubes, doctors will guide instruments to the heart to carefully slice away the thickened tissue. Participants will need to attend three follow-up visits within a year after the procedure to monitor their recovery. The trial is currently recruiting participants, and it’s important for anyone interested to discuss their eligibility with their healthcare provider.

Gender

ALL

Eligibility criteria

• * 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