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NCT06269640 · ClinicalTrials.gov registry record · NA
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Early Feasibility Study
A NA study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Terminated
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT06269640: Clinical Trial NA study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT06269640 is a NA study that was terminated before completion, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 1 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06269640, a NA study, was terminated before completion, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- TERMINATED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DEVICE Septal Scoring Along Midline Endocardium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2024-12-18 |
| Est. Completion | 2024-12-23 |
| Phase | NA |
Why NCT06269640 stopped before completion
NCT06269640 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Septal Scoring Along Midline Endocardium is the first listed.
NCT06269640 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06269640 about?
NCT06269640 is a clinical study titled "NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Early Feasibility 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 se...
What is the current status of trial NCT06269640?
This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2024-12-18. Estimated completion is 2024-12-23.
What interventions are being tested in trial NCT06269640?
The interventions under investigation include: Septal Scoring Along Midline Endocardium (DEVICE).
Who is sponsoring clinical trial NCT06269640?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06269640's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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