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New treatment option for Heart Failure
Official title Corheart 6: Long-term Cohort Study
ClinicalTrials.gov ID: NCT07094919
What this study is testing
- What it's testing
- This study aims to evaluate the long-term effectiveness and safety of Corheart 6 left ventricular assist system as a treatment for patients with advanced left heart failure. The patients who have received the Corheart 6 treatment since October 2021, or who are planned to received it, will be enrolled until the target sample size meets statistical requirements.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years.
- Subject who have undergone Corheart 6 implantation on or after October 1, 2021.
- Body Surface Area (BSA) \> 1.0 m2.
- Women of childbearing potential must use agree to use a effective method of contraception for the duration of the study.
- Diagnosis of NYHA Class IV heart failure, refractory to optimal guideline-directed medical therapy (GDMT) (e.g., ACE inhibitors, β-blockers, and...
You likely can't join if
- Heart failure caused by unresolved thyroid disease, hypertrophic obstructive cardiomyopathy, pericardial disease, or related conditions.
- Presence of active, uncontrolled infection confirmed through clinical symptoms and laboratory tests.
- Based on the investigator's judgment, presence of technical difficulties that would lead to unacceptable surgical risk.
- Subject is intolerant to anticoagulation or antiplatelet therapy, or cannot receive other perioperative and postoperative treatments deemed necessary...
- Require biventricular assist device support.
- Pregnancy.
See the full eligibility criteria
- Age ≥ 18 years.
- Subject who have undergone Corheart 6 implantation on or after October 1, 2021.
- Body Surface Area (BSA) \> 1.0 m2.
- Women of childbearing potential must use agree to use a effective method of contraception for the duration of the study.
- Diagnosis of NYHA Class IV heart failure, refractory to optimal guideline-directed medical therapy (GDMT) (e.g., ACE inhibitors, β-blockers, and diuretics).
- Left Ventricular Ejection Fraction (LVEF) \< 30%, with at least one of the following conditions:
- Dependence on an intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation (ECMO), or other short-term mechanical circulatory support with an inability to be weaned.
- Dependence on continuous intravenous inotropic support.
- Meets the diagnostic criteria for cardiogenic shock: blood pressure \ 18 mmHg
- Subject or their legally authorized representative agrees to participate in the study and signs the informed consent form.
- Heart failure caused by unresolved thyroid disease, hypertrophic obstructive cardiomyopathy, pericardial disease, or related conditions.
- Presence of active, uncontrolled infection confirmed through clinical symptoms and laboratory tests.
- Based on the investigator's judgment, presence of technical difficulties that would lead to unacceptable surgical risk.
- Subject is intolerant to anticoagulation or antiplatelet therapy, or cannot receive other perioperative and postoperative treatments deemed necessary by the investigator based on the patient's health condition.
- Require biventricular assist device support.
- Pregnancy.
- Presence of moderate to severe aortic regurgitation or a history of mechanical aortic valve implantation but refuse or is unable to converted to a bioprosthesis or oversewn at the time of LVAD implant.
- History of any organ transplant.
- Presence of unresolved thrombocytopenia or severe coagulopathy, such as disseminated intravascular coagulation (DIC).
- Preoperative total bilirubin (TBIL) \> 3.0 mg/dL, serum creatinine (SCr) \> 3.0 mg/dL, or requirement for dialysis within 48 hours prior to surgery.
- History of severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, or diagnosed primary pulmonary hypertension.
- Presence of pulmonary embolism within 3 weeks prior to enrollment.
- Pulmonary artery systolic pressure greater than 60 mmHg and meet at least one of the criteria which prove the pulmonary vessels is unresponsive to pharmacologic intervention: a. most recent pulmonary vascular resistance...
- History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) \> 5 cm in diameter.
- Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration.
- Mental illness/disorder, irreversible cognitive dysfunction, or psychosocial issues that may prevent the patient from adhering to the study protocol and the management of the implanted left ventricular assist device, or...
- Presence cancer or other diseases that could limit survival to less than 24 months.
- Participation in any other clinical investigation that is likely to confound study results or affect the study.
- Unforeseen circumstances that the investigator determines to be unsuitable for the study.
The study team makes the final eligibility decision.
Where it's taking place
- Shenzhen, Guangdong, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Nanjing, Jiangsu, China
- Beijing, China
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenzhen, Guangdong, China; Zhengzhou, Henan, China; Wuhan, Hubei, China; Nanjing, Jiangsu, China; Beijing, China; Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.