EN 
JA FIH
臨床試験（FIH）の結果
Overview
Research Overview
in patients with dilated cardiomyopathy.
心臓形状矯正ネットの臨床POC
これまでに実施された臨床試験は、左室拡張をきたした拡張型心筋症患者に対し、心臓リモデリングの進行を防止する目的で開発された「テーラーメイド方式右室拘束軽減型心臓形状矯正ネット」の安全性、および有効性の評価を主体とした、多施設共同の臨床研究（First In Human：FIH）と医師主導型探索的治験である。
jRCTs042180025：拡張型心筋症に対するテーラーメイド方式心臓形状矯正ネットの臨床試験
jRCT2042210157：拡張型心筋症に対するテーラーメイド方式心臓形状矯正ネットの医師主導治験
主要評価項目は本試験機器の安全性、および運動耐容能の改善とするが、副次評価項目として心機能の改善、左室リモデリング防止、QOLの改善等も評価する。
01Main selection criteria
| Target Patients (Target Diseases) |
Patients with dilated cardiomyopathy presenting with heart failure and NYHA classification III or IV whose symptoms do not improve with current treatment (excluding patients who are planned for concomitant surgery such as mitral valve replacement, mitral valve plication, or tricuspid valve plication) 18歳以上、80歳以下の男女 |
|---|---|
| selection criteria |
Patients who meet all of the following criteria will be selected as subjects Patients who have given written consent to participate in the study of their own free will Patients who are at least 20 years old and less than 75 years old at the time of consent Patients with persistent heart failure symptoms despite at least 3 months of optimal medical therapy for heart failure (ACE inhibitors, ARBs, diuretics, beta-blockers, oral inotropic agents, etc.) and no improvement with current therapy. Patients with NYHA Classification III or IV and Level 4 to 7 of INTERMACS Profile Patients with LVEDD≥60mm or LVEDDi≥30mm/m2 on echocardiography Patients with LVEF ≤ 351 TP3T on echocardiography or RI Patients with RVEDVi ≤ 170 mL/m2 on MRI or contrast CT scan Patients who are willing to undergo follow-up examinations and observations and who are able to visit the implementing institution. |
| exclusion criteria |
Patients who meet any of the following criteria should be excluded Patients with excessive cardiac enlargement (LVEDD > 85 mm) Patients with severely depressed left ventricular function (LVEF <10%) Patients with a history of previous cardiac surgery (except for patients with pericardial effusion and minimal pericardial adhesion, and excluding ICD and pacemaker implantation surgery) Patients scheduled for other cardiac surgery Patients with a history of CABG or scheduled for CABG Patients or candidates for PCI or transmyocardial laser revascularization within 3 months prior to surgery Patients undergoing IABP Patients with NYHA Classification IV who are candidates for assisted cardiac device and heart transplantation. Patients who have undergone biventricular paging (CRT (including ICD and pacemaker implantation surgery) or are scheduled to undergo CRT within 3 months prior to surgery. Patients expected to live less than 1 year ・Last stage heart failure patients with increased surgical risk |
02research methods
- 各共同研究施設（5大学）において同意の得られた対象患者に対して、心臓画像およびカテーテル検査より設計されたテーラーメイド方式心臓形状矯正ネットを作成し、全身麻酔下に装着する。
- Cardiac function, cardiac remodeling effects, quality of life, and exercise tolerance will be evaluated at 6 months to assess adverse events and efficacy.
- Nagoya University will be in charge of the Clinical Trials Secretariat.
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心臓形状矯正ネット治療についてや、
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