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New treatment option for Cardiogenic Shock
Official title An Interventional Left Ventricular Assist System for Cardiogenic Shock
ClinicalTrials.gov ID: NCT06127927
What this study is testing
- What it's testing
- Imported Impella The price is relatively expensive and difficult for ordinary patients to afford. In order to better meet the growing clinical needs in China, Anhui Tongling Bionic Technology Co., Ltd.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- For Pre-trial Phase
- Age 18-75 years old;
- Refractory cardiogenic shock as determined by the cardiac MDT expert group; The criteria for refractory cardiogenic shock are: despite adequate doses...
- The subject can understand the purpose of the trial, voluntarily participate and sign the written informed consent form reviewed and approved by the...
You likely can't join if
- Right heart failure that meets any of the following conditions: a Central venous pressure-capillary wedge pressure ≥10mmHg; b Central venous...
- Any peripheral vascular disease that prevents the placement of the trial device;
- Left or right ventricular thrombus;
- Aortic valve regurgitation, echocardiographic grade ≥2+;
- Aortic valve stenosis, valve area ≤1.5cm2;
- Aortic valve calcification;
See the full eligibility criteria
Who can join
- For Pre-trial Phase
- Age 18-75 years old;
- Refractory cardiogenic shock as determined by the cardiac MDT expert group; The criteria for refractory cardiogenic shock are: despite adequate doses of two vasoactive drugs and treatment of the underlying cause, there...
- The subject can understand the purpose of the trial, voluntarily participate and sign the written informed consent form reviewed and approved by the ethics committee; the subject agrees to complete the follow-up in...
What rules you out
- Right heart failure that meets any of the following conditions: a Central venous pressure-capillary wedge pressure ≥10mmHg; b Central venous pressure-pulmonary artery diastolic pressure ≥10mmHg; c Cardiac tamponade.
- Any peripheral vascular disease that prevents the placement of the trial device;
- Left or right ventricular thrombus;
- Aortic valve regurgitation, echocardiographic grade ≥2+;
- Aortic valve stenosis, valve area ≤1.5cm2;
- Aortic valve calcification;
- Presence of mechanical aortic valve;
- Hypertrophic or obstructive cardiomyopathy;
- Untreated ventricular septal or atrial septal defect;
- Patent foramen ovale;
- Mechanical complications of acute myocardial infarction;
- Presence of hereditary spherocytosis, hereditary elliptocytosis, autoimmune hemolytic anemia or other diseases that cause hemolysis;
- Cardiopulmonary resuscitation lasting more than 15 minutes within 24 hours before catheter pump implantation;
- Ventricular tachycardia or ventricular fibrillation is ineffective with drug treatment;
- Renal failure, serum creatinine ≥309.4umol/l or blood urea nitrogen ★ ≥35.7mmol/l);
- Liver failure (total bilirubin ≥85.5umol/l);
- Allergy or intolerance to heparin;
- Presence of any cardiac assist device;
- Presence of active systemic infection;
- Refusing to sign the informed consent form or failing to complete follow-up as required by the protocol;
- Pregnant or lactating women, female people with potential fertility but unable or unwilling to use effective contraceptive measures during the study;
- people who have participated in other clinical trials within 3 months or are currently participating in other clinical trials;
- Other situations that the investigator believes are not suitable for clinical trials. For Formal Research Phase Inclusion Criteria:
- Age 18-75 years old;
- Low cardiac output syndrome or increased filling pressure after regular continuous pumping of 1 high-dose or 2 medium-dose inotropic drugs within 48 hours after cardiopulmonary bypass was removed during cardiac surgery...
- Right heart failure that meets any of the following conditions:
- Central venous pressure-capillary wedge pressure ≥10mmHg;
- Central venous pressure-pulmonary artery diastolic pressure ≥10mmHg;
- Cardiac ascites.
- Any peripheral vascular disease that prevents the placement of the trial device;
- Left or right ventricular thrombus;
- Aortic valve regurgitation, echocardiographic grade ≥2+;
- Aortic valve stenosis, valve area ≤1.5cm2;
- Presence of mechanical aortic valve;
- Hypertrophic or obstructive cardiomyopathy;
- Untreated ventricular septal or atrial septal defect;
- Patent foramen ovale;
- Mechanical complications of acute myocardial infarction;
- Suffering from diseases that cause increased blood cell fragility or hemolysis;
- Cardiopulmonary resuscitation lasting more than 15 minutes within 24 hours before catheter pump implantation;
- Sustained or non-sustained ventricular tachycardia or ventricular fibrillation that is unresponsive to drug treatment;
- Renal failure, serum creatinine ≥3.5mg/dl or blood urea nitrogen ≥100mg/dl;
- Liver failure, total bilirubin ≥5mg/dl;
- Allergy or intolerance to heparin;
- Other cardiac assist devices other than IABP have been implanted;
- Active systemic infection;
- Refuse to sign the informed consent form or fail to complete follow-up as required by the protocol;
- Pregnant or lactating women, female people with potential fertility but unable or unwilling to use effective contraceptive measures during the study;
- people who are participating in other clinical trials and have not yet reached the endpoints of the trial;
- Other situations that the investigator believes are not suitable for clinical trials.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, 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.