Implementation period and number of participants
This clinical study will be conducted from September 2019 to December 2021 (follow-up period of 2er4ree years after surgery), and a total of 3 patients will participate in all facilities.
Participants in clinical research
Participants in this clinical study are those who meet the following conditions:
In addition, you may not be able to participate in this clinical study if any of the following applies.
There are several other criteria for participating in clinical research. In addition, even after consenting to participate in a clinical study, you may not be able to participate depending on the results of prior tests to see if the criteria are met.
Expected effects and disadvantages
(1) Expected major effects
In a large animal model of chronic heart failure (dogs, pigs), when compared with the control group (group without net) and the normal net group (group with net without an opening in the right ventricle), the test equipment (cardiac support net with an opening on the right ventricle) indicated that the contractility of the right and left ventricles was significantly improved. In cardiac simulations in a chronic heart failure model using a supercomputer, our test equipment (a heart support net with a perforated right ventricle) increases cardiac output and reduces energy consumption of the left ventricular myocardium and found to be effective and improve the energy efficiency of the left ventricle. In the state of heart failure, the orientation of myocardial fibers is disturbed and the contraction efficiency is reduced, but simulations have shown that the disorder is improved by implanting test equipment. These results indicate that this test device can be expected to improve cardiac function immediately after implantation.
According to the results of overseas clinical trials of similar medical devices devised overseas, these devices reduce the size and capacity of the left ventricle, improve the ejection fraction of the left ventricle, and change the heart to a more elliptical shape. It is also expected to reduce the needs for major heart surgery required for the progression of heart failure, and improve the patient's quality of life (QOL).
The following is a summary of the results of overseas clinical trials using similar medical devices.
* Reference: "Clinical Evaluation of the CorCap Cardiac Support Device in Patients With Dilated Cardiomyopathy" 2007, The Society of Thoracic Surgeons
: "Clinical evaluation of CorCap cardiac assist device for patients with dilated cardiomyopathy" 2007 American Thoracic Surgery Society (Elsevier)
A total of 300 patients participated. There were 148 patients treated with similar medical devices (test device group) and 152 patients not treated with similar medical devices (control group). Some of these patients have undergone mitral valve repair and replacement.
The table below summarizes the results of post-treatment changes in the NYHA classification that determine the severity of heart failure and the percentage of patients who have not undergone major cardiac surgery after treatment. Patients treated with similar medical devices (test device group) had a higher improvement rate of NYHA classification at 45%, and those who had not undergone major cardiac surgery had a higher rate of 89%, and the effect was high.
(2) Expected major disadvantages
After the implantation surgery, the net of the test equipment may have deteriorated and the net may have torn, but in the 100 million endurance test (equivalent to the heart rate for 3 years), no deterioration or tear of the net was observed. In fact, within a few months after surgery, the net is expected to adhere to your heart and stabilize its strength.
Complications include perioperative (immediately after implantation) infections (wound infections, pneumonia, catheter infections, etc.), bleeding, worsening heart failure, and effects on coronary arteries (blood vessels around the heart). In the distant period (sometime after implantation), constrictive pericarditis may occur.
Wound infection: An infection that occurs at the surgical site. It can happen at a certain frequency. In general, it has been reported that surgery to transplant artificial objects increases the likelihood of infection. The cardiovascular surgery department of the research facility has taken various preventive measures against wound infections and is doing its best to prevent wound infections.
Effects on coronary arteries: The test device (cardiac support net) works by compressing the surface of the heart. Therefore, there is a concern that the coronary arteries may be compressed and the blood flow in the coronary arteries may be reduced. In this regard, animal studies have been conducted to confirm that implantation of test equipment does not affect the blood flow reserve or morphology of the coronary arteries.
Constrictive pericarditis: Since a test device (foreign body) is attached around the heart, there is a concern that constrictive pericarditis may occur in the remote period, where the surface tissue of the heart becomes fibrotic or calcified. However, it has been reported that there was no occurrence of constrictive pericarditis in a 5-year clinical trial of Acorn CorCap, a similar medical device of this study device. In addition, in the long-term implantation test in animals with our test equipment, the tissue reaction and adhesion around the heart were slight.
Other common adverse events that may occur in connection with heart surgery include: Allergic reaction, arrhythmia, cardiac tamponade, chronic pain, death, cardiogenic shock, deterioration of hemodynamics that may lead to neuropathy, infection / sepsis, local skin reaction, myocardial infarction, surgical disorder, epicardial fluid , Pericarditis, pneumothorax, disorders leading to lung / kidney / liver failure, reoperation, thromboembolism
The table below shows the results in the same literature as in "Overseas clinical trials with similar medical devices" in "(1) Expected major effects". It shows the number of serious adverse events among the adverse events (all unfavorable events that occurred during clinical trial participation) during the entire observation period. Among them, there was no event (side effects) suspected to be caused by similar medical devices.
Furthermore, as of December 2004, 174 patients in five European countries (France, Germany, the Netherlands, Sweden, and Italy) have a track record of using similar medical devices. Even in such patients, no adverse events suspected to be caused by similar medical devices have been reported. These adverse events have been reported so far, and not all adverse events occur in all patients. The doctor in charge will closely observe the expected adverse events and symptoms as described above, and provide appropriate treatment each time.
Cases where participation in the exam is canceled
After participating in this clinical trial, the patient may be discontinued from participating in the trial if any of the following occurs. Even in that case, please be assured that we will provide appropriate treatment for you.
Even if participation in the test is canceled, we will conduct medical examinations and tests as much as possible to confirm the safety at the time of cancellation. Please note that once the test equipment is implanted, it will not be removed in principle.
Correspondence after the test
If the adverse events that occurred during the study period did not recover and continue, in principle, our follow-up will be conducted until the symptoms recover or stabilize. If any adverse events that may be related to the test equipment are found after the test, follow-up will be conducted.
In case of test-related health hazards
This clinical trial is scientifically planned based on the results of previous studies and trials, and patient safety is our top priority.
The treatment performed this time is not the standard treatment for dilated cardiomyopathy. However, we believe that this clinical trial can be expected to have effects such as suppressing the expansion of the dilated left ventricle and improving cardiac function. If this test causes any health hazard, we will provide the best treatment within the scope of normal medical care. In addition, we take out compensation insurance to provide appropriate compensation for health hazards. In addition, we take out clinical research insurance in case of unexpected serious adverse events that are suspected to be caused by the test equipment and leave aftereffects.
Cost burden in clinical trials
Each facility will bear the cost of the surgery to attach the cardiac support net. All planned in-hospital examinations, cardiac support net installation surgery costs and hospitalization costs will be covered by research expenses. Medical insurance will cover the cost of medical treatment after discharge.
Providing inspection data to the outside
What we want patients to comply
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