EN 
JA FIH
Results of Clinical Studies (FIH)
Overview
Research Overview
in patients with dilated cardiomyopathy.
Cardiac Assist Net Clinical POC
This clinical study is a multicenter, first-in-human (FIH) clinical study mainly evaluating the safety of the "Taylor Made Right Ventricular Restraint Reducing Cardiac Shape Correction Net," which was developed to prevent the progression of cardiac remodeling in patients with dilated dilated left ventricular myocardiopathy.
jRCTs042180025: Clinical trial of a tailor-made heart shape correction net for dilated cardiomyopathy.
The primary endpoint is to evaluate the safety of the study device, but efficacy in terms of improvement of cardiac function, prevention of left ventricular remodeling, and improvement of quality of life will also be evaluated in an exploratory manner as secondary endpoints.
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) |
|---|---|
| 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
- Patients at each of the five collaborating institutions (five universities) who have given their consent will undergo cardiac imaging and catheterization to create a tailor-made cardiac shape correction net, which will be placed under general anesthesia.
- 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.
Summary of three clinical studies
CLINICAL DATA
- Three NYHA-III dilated cardiomyopathy patients over 65 years old who were off-label for heart transplantation were fitted with a Taylor-made cardiac shape correcting net.
- There were no adverse event occurrences related to the test equipment.
- Cardiac function improved during the second half of surgery and during the ICU stay.
- Evaluation at 24 weeks postoperatively revealed marked improvement in pulmonary congestion and significant improvement in exercise tolerance. The improvement in exercise capacity was maintained at 1 year postoperatively.
- As of April 2022, the first case is 2 years and 5 months postoperative, the second case is 2 years postoperative, and the third case is 1 year and 1 month postoperative and enjoying an active daily life.
- All patients were able to reduce the dose of loop diuretics and the progression of CKD was prevented.
- Worsening of cardiac remodeling was also prevented, and in one case, clear reverse remodeling was obtained.
- PMDA Clinical Trial Protocol Consultation (Exploratory Trial) Face-to-Face Advice was conducted on R3.7.27 based on the study results.
- Nagoya University IRB Approval October 28, 2021
- PMDA clinical trial notification submitted (February 1, 2021) 30 days surveyed
- Exploratory clinical trials at 5 universities nationwide to begin in May 2022.
- AMED Bridge Research PreC adopted in FY2021, additional support adopted in January 2022.
- Adopted as AMED Seeds C for bridging research
CONTACT
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