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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06269640
The ClinicalTrials.gov registry entry for NCT06269640 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Septal Scoring Along Midline Endocardium is the first listed.
NCT06269640 reports 0 study locations.
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.
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