EN 
JA Participation in Clinical Trials
Nagoya University Hospital, together with five other university hospitals in Japan, is conducting a clinical trial to investigate the efficacy and safety of a medical device under development, the Cardiac Correction Net, using test equipment manufactured by iCorNet Laboratories, Inc. We are working on clinical trials to investigate the efficacy and safety of the heart shape corrective net, a medical device under development.
We are preparing to recruit patients who understand this clinical trial and are willing to participate in it, so if you are interested, please contact us at "Inquiries".
Inquiry for Clinical Trial Participation
For dilated cardiomyopathy
Taylor Made Method
Heart Shape Correction Net(at sentence-end, falling tone) indicates a confident conclusion
Exploratory Physician-Initiated Clinical Trials
Basic Information
| state of progress | Preparing to accept participants |
|---|---|
| target disease | non-ischemic dilated cardiomyopathy |
| Test start date (tentative) | May 16, 2022 |
| Target number of cases | 5 cases |
| Countries where clinical research is conducted | Japan |
| Type of research | intervention study |
| Intervention Description | To evaluate the efficacy and safety of a tailor-made cardiac shape correction net, developed to prevent the progression of left ventricular remodeling, in dilated cardiomyopathy patients with left ventricular dilatation at 24 weeks postoperatively. |
Examination Details
| Primary Endpoint |
Safety assessment: adverse events from surgery to 24 weeks postoperatively, failure of study equipment Efficacy evaluation: exercise tolerance at 24 weeks postoperatively (cardiopulmonary exercise test: Peak VO2) |
|---|---|
| secondary endpoint |
1) Evaluation of improvement in cardiac function and prevention of left ventricular remodeling 2) Exercise tolerance 3) Cardiac-related events up to 24 weeks postoperatively |
target disease
| Age (lower limit) | Over 20 years old |
|---|---|
| Age (upper limit) | Under 75 years old |
| gender | both men and women |
| selection criteria |
1) Patients who have given written consent to participate in the clinical trial of their own free will 2) Patients who are at least 20 years old and less than 75 years old at the time of obtaining consent. 3) Patients with persistent heart failure symptoms despite optimal medical therapy (ACE inhibitors, ARBs, diuretics, beta-blockers, oral inotropic agents, SGLT2 inhibitors, ARNI, HCN channel inhibitors, etc.) for heart failure for at least 3 months at the time of consent and no improvement in symptoms with current therapy. 4) Patients with NYHA classification IIm to IV and Level 4 to 7 of INTERMACS Profile 5) Patients with LVEDD ≥ 60 mm or LVEDDi ≥ 30 mm/m2 on echocardiography 6) Patients with LVEF ≤ 351 TP3T on echocardiography 7) Patients with Peak VO2 of 7.0 to 16.0 mL/kg/min on cardiopulmonary exercise stress test 8) Patients who can undergo cardiac MRI or contrast-enhanced cardiac CT scan and cardiac catheterization for the manufacture of investigational devices 9) Patients who are willing to undergo follow-up examinations and observations and are able to visit the implementing medical institution. |
| exclusion criteria |
1) Patients with excessively enlarged heart (LVEDD > 90 mm on echocardiography) 2) Patients with severely impaired left ventricular function (LVEF < 101 TP3T on echocardiography) 3) Patients planning to undergo concomitant surgery such as mitral valve replacement, mitral valvuloplasty, tricuspid valvuloplasty, etc. 4) Patients with a history of previous cardiac surgery. However, this does not apply to patients with pericardial effusions and minimal pericardial adhesions, and patients who have undergone pacemaker therapy using a transvenous lead (ICD, CRT-P, CRT-D) for 3 months. 5) Patients being treated with other cardiac treatment devices such as IABP, ECMO, etc. or scheduled for other cardiac surgical procedures 6) Patients who have had acute myocardial infarction or unstable angina pectoris, or who have undergone PCI or transmyocardial laser revascularization within 3 months prior to obtaining consent, or who are candidates for such procedures 7) Patients with NYHA Classification IV and indication for artificial heart device and patients on the waiting list for heart transplantation 8) Patients with diastolic phase hypertrophic cardiomyopathy 9) Patients with active infection 10) Patients with a history of cerebrovascular disorder (cerebral infarction, cerebral hemorrhage, etc.) within 3 months prior to obtaining consent 11) Patients with severe bleeding tendency or blood coagulation disorder (patients with contraindication to antithrombotic therapy) 12) Patients with malignant diseases with poor prognosis such as advanced cancer 13) Patients with severe dementia, drug addiction, or alcoholism 14) Patients with severe allergies 15) Pregnant or lactating patients, or patients who cannot consent to contraception during the clinical trial 16) Patients participating in other interventional trials 17) Other patients, such as patients with last-stage heart failure with increased surgical risk, patients with severe hepatic dysfunction, renal failure, or pulmonary function problems, for whom the investigator or subinvestigator determines that participation in the study is inappropriate. |
medical expenses not covered by insurance
|
Uninsured combined medical care expenses presence or absence |
None (Patients are not responsible for any direct medical costs associated with the implantation of the investigational device.) |
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Related Information
| principal investigator | Masato Rokka |
|---|---|
| Name of organization providing research funds, etc. | AMED Bridging Research Seeds C |
Contact for Inquiries
| person in charge (of an area of work, but not necessarily supervising other staff) | Toshiaki Akita (Clinical Trial Coordinator) |
|---|---|
| Organization | Nagoya University Hospital |
| Department | heart surgery |
| postal code | 466-8550 |
| address (e.g. of house) | 65 Tsurumai, Showa-ku, Nagoya, Aichi, Japan |
| takita@med.nagoya-u.ac.jp |
