NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
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.
調査の概要
状態
介入・治療
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Robert J Lederman, M.D.
- 電話番号：(301) 402-6769
- メール：robert.lederman@nih.gov
研究場所
-
-
District of Columbia
-
Washington D.C.、District of Columbia、アメリカ、20010
- MedStar Washington Hospital Center
-
コンタクト：
- Toby Rogers, M.D.
- 電話番号：202-877-5975
-
-
Georgia
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Atlanta、Georgia、アメリカ、30322
- Emory University Hospital
-
コンタクト：
- Vasilis Babaliaros, M.D.
- 電話番号：678-557-4514
-
コンタクト：
- Adam B Greenbaum, M.D.
- 電話番号：(678) 557-4514
- メール：adam.b.greenbaum@emory.edu
-
-
Massachusetts
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Boston、Massachusetts、アメリカ、02215
- Beth Israel Deaconess Medical Center
-
コンタクト：
- James McCabe, M.D.
- 電話番号：617-667-8800
-
-
New York
-
Roslyn、New York、アメリカ、11576
- St. Francis Hospital & Heart Center
-
コンタクト：
- Jaffar M Khan, M.D.
- 電話番号：516-390-9640
-
The Bronx、New York、アメリカ、10461
- Montefiore Medical Center: Einstein Campus
-
コンタクト：
- Mohamed Azeem Latib, M.D.
- 電話番号：718-920-4212
-
-
Pennsylvania
-
York、Pennsylvania、アメリカ、17403
- WellSpan York Hospital
-
コンタクト：
- Christopher G Bruce, M.D.
- 電話番号：717-851-2441
-
-
Virginia
-
Charlottesville、Virginia、アメリカ、22908
- Univ. of Virginia
-
コンタクト：
- John Saxon, M.D.
- 電話番号：434-243-1000
-
Roanoke、Virginia、アメリカ、24014
- Carilion Roanoke Memorial Hospital
-
コンタクト：
- Jason Foerst, M.D.
- 電話番号：540-982-8204
- メール：jrfoerst@carilionclinic.org
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
- 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
and
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
EXCLUSION CRITERIA
- Does not consent to participate, or unable to consent to participate
- Pregnant
- Hemodynamic instability or emergency procedure
- Mechanical aortic valve
- eGFR < 30 mL/min/1.73m^2
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：SESAME Arm
The intervention is the SESAME procedure.
|
The intervention is the SESAME procedure, a catheter-based septal myotomy performed in adults with symptomatic or high-risk LVOT obstruction.
It uses off-label Astato XS 20/40 guidewires and the NHLBI LCI electrosurgery timing appliance to create a controlled longitudinal laceration through the hypertrophied interventricular septum under fluoroscopic and echocardiographic guidance, with energy delivery limited to short pulses and cooling intervals to reduce thermal injury; all participants receive the same procedure, with follow-up assessments afterward.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
SESAME Technical Success
時間枠：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%.
|
Completion of SESAME procedure
|
|
SESAME Safety
時間枠：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.
|
30 days after SESAME procedure
|
協力者と研究者
捜査官
- 主任研究者：Robert J Lederman, M.D.、National Heart, Lung, and Blood Institute (NHLBI)
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 10002783
- 002783-H
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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