Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06269640
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-02-17
Brief Title:
NHLBI SESAME SEptal Scoring Along Midline Endocardium Early Feasibility Study
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
NHLBI SESAME SEptal Scoring Along Midline Endocardium Early Feasibility Study
Status:
RECRUITING
Status Verified Date:
2024-09-23
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Cardiac interventricular septal reduction therapies - to relieve left ventricular outflow tract obstruction from transcatheter valve replacement or hypertrophic cardiomyopathy - have inherent limitations including dependence on coronary anatomy high pacemaker implantation rate and surgical morbidity We developed a novel transcatheter ventricular myotomy called SEptal Scoring Along the Midline Endocardium SESAME that relies on intramyocardial guidewire navigation and transcatheter electrosurgery SESAME has been performed on a small number of patients using off label devices
This study systematically characterizes the safety and early feasibility of SESAME at 1 enrolling site SESAME is performed as septal reduction therapy in a heterogeneous group of subjects including symptomatic hypertrophic cardiomyopathy and resting or provoked left ventricular outflow obstruction LVOTO and severe symptomatic mitral andor aortic valve disease at high risk of standard heart surgical therapy and requiring later transcatheter heart valve implantation combined with manifest or potential LVOTO
A key goal of this study is to attempt to capture generalizable knowledge from as many patients as possible and to add a limited number of research procedures to characterize the safety and provisional effectiveness of SESAME Absent realistic non-clinical models of HCM or LVH combined with aortomitral disease we believe little more information can be gleaned without clinical investigation
This study systematically characterizes the safety and early feasibility of SESAME at 1 enrolling site SESAME is performed as septal reduction therapy in a heterogeneous group of subjects including symptomatic hypertrophic cardiomyopathy and resting or provoked left ventricular outflow obstruction LVOTO and severe symptomatic mitral andor aortic valve disease at high risk of standard heart surgical therapy and requiring later transcatheter heart valve implantation combined with manifest or potential LVOTO
A key goal of this study is to attempt to capture generalizable knowledge from as many patients as possible and to add a limited number of research procedures to characterize the safety and provisional effectiveness of SESAME Absent realistic non-clinical models of HCM or LVH combined with aortomitral disease we believe little more information can be gleaned without clinical investigation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 001640-H | None | None | None |