Heart Failure
Conditions
Brief summary
Feasibility study of the DuoCor Ventricular Assist System as a treatment for advanced total heart failure patients.
Interventions
The DuoCor VAS is used to provide hemodynamic support by shareing some or all the workload of the left and right ventricles during the support period.
Sponsors
Shenzhen Core Medical Technology CO.,LTD.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients who require biventricular mechanical circulatory support, defined by either of the following criteria: * Persistent total heart failure despite optimal medical management based on current heart failure practice guidelines; OR * Development of refractory right heart failure following left ventricular assist device (LVAD) implantation, unresponsive to pharmacological interventions for right heart failure. 2. Patient has signed the informed consent, has full understanding of procedures, and is committed to following study requirements.
Exclusion criteria
1. Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patient's health status. 2. Technical obstacles which pose the implantation as unsuitable, obtaining the body type, body surface area, and anatomical conditions related to the planned implantation site, in the judgment of the experienced investigators. 3. Pregnancy. 4. Age \> 75 years. 5. Presence of an active, uncontrolled infection. 6. Brain death. 7. History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) \> 5 cm in diameter. 8. Irreversible cognitive dysfunction, psychosocial issues, or psychiatric disease, likely to impair compliance with the study protocol and DuoCor VAS management which, in the opinion of the investigator, could interfere with the ability to manage the therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of survival at 3 months post-implantation | 3 months | Composite of survival to transplant, recovery (defined as complete/ partial removal or explantation of the DuoCor VAS due to cardiac recovery), or survival with the device at 3 months post-implantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital redmission rate | 3 months | Rate of unplanned readmissions to the hospital. |
| Adverse Events. | 3 months | Adverse Event as defined in INTERMACS Adverse Events (Definition Date: 10/11/2021) |
Countries
China
Outcome results
None listed