NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 9
- 主要终点
- SESAME Technical Success
研究概览
简要总结
This is an early study of a catheter-based minimally invasive procedure called SESAME to slice thick heart muscle as described below.
Excessively-thick heart muscle can cause serious heart disease, especially heart failure with preserved ejection fraction, which causes shortness of breath and heart failure symptoms such as edema (swelling) and pulmonary congestion (lung water). Specific circumstances of excessively-thick heart muscle can block outflow of blood from the main heart pumping chamber (left ventricle).
We developed a catheter technique called SESAME (SEptal Scoring Along Midline Endocardium) to slice the excessively-thick heart muscle causing such problems. SESAME can be used in patients who have symptoms related to excessively-thick heart muscle in a part of the heart that restricts blood ejection from the heart; the problem is called "left ventricular outflow tract obstruction (LVOTO)." One group of patients who might benefit from SESAME suffer from a common inherited heart muscle disease called "hypertrophic cardiomyopathy (HCM)." Patients with HCM and symptoms from LVOTO can be treated with medications, open heart surgery, or catheter-based destruction of heart muscle in "alcohol septal ablation." If these treatments fail or are not suitable, then SESAME may be an option, because it resembles surgery treatment without open heart surgery.
Other groups of patients that might benefit are those with heart valve diseases, of the mitral or of the aortic valve, or both, along with excessively-thick heart muscle. These patients may be poor candidates for standard surgical valve repair or replacement because of high risk of complications or death. Such patients might be eligible for non-surgical transcatheter mitral valve replacement, either standard or unapproved ("off-label") or research ("investigational"), but are poor candidates because of risk of LVOTO. Moreover, about half have LVOTO making heart valve symptoms worse. Treating the LVOTO alone may improve symptoms enough that heart valve treatment can be delayed or avoided.
This is a sponsor-investigator IDE study of SESAME performed at a small number of centers that have adopted the technique in the practice of medicine, in order better to characterize how well it works and whether it is safe.
Participating centers already perform SESAME in the practice of medicine using improvised, off-label devices. This protocol allows prospective oversight, standardized technique constraints, central imaging review, independent monitoring, and formal safety adjudication. In addition, the investigational protocol does not function as the gatekeeper for access to SESAME.
The investigators are not affiliated with the guidewire manufacturer and do not seek marketing approval or clearance for SESAME.
详细描述
Cardiac septal reduction therapies - to relieve left ventricular outflow tract obstruction from transcatheter mitral 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 hundreds of patients worldwide using improvised (off-label and bedside-modified commercially available) devices. Recent benchtop refinements in SESAME technique, using improvised devices, are predicted to reduce the likelihood of serious complications such as ventricular perforation, iatrogenic ventricular septal defect, and death.
This sponsor-investigator IDE study systematically characterizes the safety and outcomes of SESAME at up to 10 enrolling sites. SESAME is performed as septal reduction therapy in a heterogeneous group of participants, including (1) symptomatic hypertrophic cardiomyopathy with resting or provoked left ventricular outflow obstruction (LVOTO); and (2) severe symptomatic mitral valve disease at high risk of standard heart surgical therapy and requiring later transcatheter mitral valve implantation combined with manifest or potential LVOTO. This study attempts to capture generalizable knowledge from as many patients as possible who undergo SESAME, and to add a limited number of research procedures to characterize the safety and provisional effectiveness of SESAME.
Participating centers already perform SESAME in the practice of medicine using improvised, off-label devices. This protocol allows prospective oversight, standardized technique constraints, central imaging review, independent monitoring, and formal safety adjudication. In addition, the investigational protocol does not function as the gatekeeper for access to SESAME.
The investigators are not affiliated with the guidewire manufacturer and do not seek marketing approval or clearance for SESAME.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA
- •Adults age >= 21 years
- •Requires left ventricular septal reduction therapy for one of two indications
- •Obstructive hypertrophic cardiomyopathy with symptomatic left ventricular outflow tract obstruction (30mmHg peak while resting OR 50mmHg peak when provoked); OR
- •Planned transcatheter mitral valve replacement is feasible but limited by risk for iatrogenic left ventricular outflow tract obstruction, defined on contrast-enhanced CT as skirt-neo-LVOT <200^2
- •Planning to undergo SESAME transcatheter myotomy
- •Septal diastolic thickness on CT as measured by the NHLBI central laboratory before enrollment:
- •For obstructive hypertrophic cardiomyopathy, >=14mm;
- •For transcatheter heart valve replacement, >=12mm
- •Intended minimum diastolic residual septal thickness >=6mm
- •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
- •cardiac myosin inhibitor therapy, if eligible (obstructive HCM only);
- •transcoronary alcohol septal ablation, if eligible; or
- •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 and that SESAME is an appropriate septal reduction strategy for this candidate.
- •Willing to return for all scheduled follow-up activities, and eligible or able to undergo required protocol and testing
排除标准
- •Does not consent to participate, or unable to consent to participate
- •Hemodynamic instability or emergency procedure
- •Mechanical aortic valve
- •eGFR < 30 mL/min/1.73m^2
研究组 & 干预措施
SESAME Arm
The intervention is the SESAME procedure.
干预措施: SESAME Procedure (Device)
结局指标
主要结局
SESAME Technical Success
时间窗: Completion of SESAME procedure
The primary outcome is technical success, defined as the participant being alive and having a successful SESAME laceration, with post-procedure CT showing that the achieved minimum residual septal thickness matches the planned thickness within 20%.
SESAME Safety
时间窗: 30 days after SESAME procedure
The primary safety endpoint is freedom at 30 days from all-cause mortality, any stroke (disabling or non-disabling), and major SESAME-related cardiac structural complications requiring intervention, such as iatrogenic ventricular septal defect, aortic or mitral regurgitation, tamponade, or new permanent pacemaker implantation.
次要结局
未报告次要终点