TERMINATED

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

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Conditions

Hypertrophic CardiomyopathyLeft Ventricular Septal HypertrophyMitral Valve DiseaseAortic Valve Stenosistranscatheter electrosurgerytranscatheter ventricular myotomyCardiac interventricular septal reduction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-12-18
Study Completion:2024-12-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT06269640

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults age \>= 21 years
  2. * Requires debulking of left ventricular septum for hypertrophic cardiomyopathy
  3. * Septal diastolic thickness of obstructive hump on CT:
  4. * Total \>=16 mm, and
  5. * Predicted residual septal thickness \>= 8 mm, and
  6. * Predicted laceration depth \>= 6 mm
  7. * Severely symptomatic, any of
  8. * NYHA Class III or greater
  9. * Canadian Angina Class CCS III or greater
  10. * 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
  11. * Concurrence of the multidisciplinary institutional heart team that the candidate is at high risk for surgical myectomy
  12. * Concurrence of the study Central Clinical Eligibility Committee
  13. * Willing to return for all scheduled follow-up activities, and eligible or able to undergo required protocol and testing
  1. * Does not consent to participate, or unable to consent to participate
  2. * Requires antegrade SESAME access (because of mechanical aortic valve)
  3. * Prior completed transcoronary alcohol septal ablation, or prior surgical myectomy
  4. * Pregnant
  5. * Hemodynamic instability or emergency procedure
  6. * eGFR \< 30 mL/min/1.73m\^2
  7. * Survival despite successful procedure expected \< 12months

Contacts and Locations

Principal Investigator

Robert J Lederman, M.D.
PRINCIPAL_INVESTIGATOR
National Heart, Lung, and Blood Institute (NHLBI)

Study Locations (Sites)

Emory University Hospital
Atlanta, Georgia, 30322
United States

Collaborators and Investigators

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

  • Robert J Lederman, M.D., PRINCIPAL_INVESTIGATOR, National Heart, Lung, and Blood Institute (NHLBI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-18
Study Completion Date2024-12-23

Study Record Updates

Study Start Date2024-12-18
Study Completion Date2024-12-23

Terms related to this study

Keywords Provided by Researchers

  • transcatheter electrosurgery
  • transcatheter ventricular myotomy
  • Cardiac interventricular septal reduction

Additional Relevant MeSH Terms

  • Hypertrophic Cardiomyopathy
  • Left Ventricular Septal Hypertrophy
  • Mitral Valve Disease
  • Aortic Valve Stenosis