New heart support system for patients with severe heart failure

Evaluation the Efficacy and Safety of an Interventional Left Ventricular Assist System for Hemodynamic Support in Patients With Cardiogenic Shock: A Prospective, Multicenter, Single-group Target Value Study of Sustained

This study tests a new heart support device for people with severe heart failure to see if it can help improve blood flow and make them feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fujian Medical University (Academic / other)
• Locations: 2 sites (Fuzhou, Fujian and 1 other locations)
• Trial ID: NCT06127927 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates an innovative interventional left ventricular assist system designed to provide hemodynamic support for patients experiencing cardiogenic shock. The device aims to improve blood flow and reduce the workload on the heart, potentially offering a more effective alternative to traditional drug therapies. The trial will assess the safety and effectiveness of this system in a clinical setting, following promising results from preclinical animal studies. Participants will be monitored closely to determine the impact of the device on their condition and overall recovery.

Who should consider this trial

Good fit: Ideal candidates for this trial are adults aged 18-75 who are experiencing refractory cardiogenic shock despite receiving adequate doses of vasoactive drugs.

Not a fit: Patients with right heart failure or significant peripheral vascular disease that prevents the placement of the device may not benefit from this trial.

Why it matters

Potential benefit: If successful, this system could significantly improve survival rates and quality of life for patients suffering from cardiogenic shock.

How similar studies have performed: While mechanical circulatory support has been used in clinical settings for decades, this specific device represents a novel approach that has not been extensively tested in human subjects.

Eligibility criteria

For Pre-trial Phase

Inclusion Criteria:

1. Age 18-75 years old;
2. 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 is still evidence of tissue hypoperfusion;
3. 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 accordance with the protocol requirements.

Exclusion Criteria:

1. 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.
2. Any peripheral vascular disease that prevents the placement of the trial device;
3. Left or right ventricular thrombus;
4. Aortic valve regurgitation, echocardiographic grade ≥2+;
5. Aortic valve stenosis, valve area ≤1.5cm2;
6. Aortic valve calcification;
7. Presence of mechanical aortic valve;
8. Hypertrophic or obstructive cardiomyopathy;
9. Untreated ventricular septal or atrial septal defect;
10. Patent foramen ovale;
11. Mechanical complications of acute myocardial infarction;
12. Presence of hereditary spherocytosis, hereditary elliptocytosis, autoimmune hemolytic anemia or other diseases that cause hemolysis;
13. Cardiopulmonary resuscitation lasting more than 15 minutes within 24 hours before catheter pump implantation;
14. Ventricular tachycardia or ventricular fibrillation is ineffective with drug treatment;
15. Renal failure, serum creatinine ≥309.4umol/l or blood urea nitrogen ★ ≥35.7mmol/l);
16. Liver failure (total bilirubin ≥85.5umol/l);
17. Allergy or intolerance to heparin;
18. Presence of any cardiac assist device;
19. Presence of active systemic infection;
20. Refusing to sign the informed consent form or failing to complete follow-up as required by the protocol;
21. Pregnant or lactating women, female subjects with potential fertility but unable or unwilling to use effective contraceptive measures during the study;
22. Subjects who have participated in other clinical trials within 3 months or are currently participating in other clinical trials;
23. Other situations that the investigator believes are not suitable for clinical trials.

For Formal Research Phase

Inclusion Criteria:

1. Age 18-75 years old;
2. 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. The specific criteria are as follows;

The drugs, doses and time of 1 high-dose or 2 medium-dose inotropic drugs are as follows:

Epinephrine: medium dose (\<0.03 μg/kg/min), continuous pumping ≥15 minutes High dose (≥0.03 μg/kg/min), continuous pumping ≥15 minutes; Dobutamine: medium dose (\<5μg/kg/min), continuous pumping ≥15 minutes High dose (≥5μg/kg/min), continuous pumping ≥15 minutes; Milrinone: medium dose (\<0.3 μg/kg/min), continuous pumping ≥120 minutes High dose (≥0.3 μg/kg/min), continuous pumping ≥120 minutes; Low cardiac output syndrome: cardiac index 1.3≤CI≤2.2 L/min/m2;

Increased filling pressure: pulmonary capillary wedge pressure:

20≤PCWP≤30mmHg or pulmonary artery systolic pressure: 25≤PAP≤35mmHg 3) The subject can understand the purpose of the trial, voluntarily participate and sign the informed consent form reviewed and approved by the ethics committee; the subject agrees to complete the follow-up in accordance with the protocol requirements.

Exclusion Criteria:

1. Right heart failure that meets any of the following conditions:

   1. Central venous pressure-capillary wedge pressure ≥10mmHg;
   2. Central venous pressure-pulmonary artery diastolic pressure ≥10mmHg;
   3. Cardiac ascites.
2. Any peripheral vascular disease that prevents the placement of the trial device;
3. Left or right ventricular thrombus;
4. Aortic valve regurgitation, echocardiographic grade ≥2+;
5. Aortic valve stenosis, valve area ≤1.5cm2;
6. Presence of mechanical aortic valve;
7. Hypertrophic or obstructive cardiomyopathy;
8. Untreated ventricular septal or atrial septal defect;
9. Patent foramen ovale;
10. Mechanical complications of acute myocardial infarction;
11. Suffering from diseases that cause increased blood cell fragility or hemolysis;
12. Cardiopulmonary resuscitation lasting more than 15 minutes within 24 hours before catheter pump implantation;
13. Sustained or non-sustained ventricular tachycardia or ventricular fibrillation that is unresponsive to drug treatment;
14. Renal failure, serum creatinine ≥3.5mg/dl or blood urea nitrogen ≥100mg/dl;
15. Liver failure, total bilirubin ≥5mg/dl;
16. Allergy or intolerance to heparin;
17. Other cardiac assist devices other than IABP have been implanted;
18. Active systemic infection;
19. Refuse to sign the informed consent form or fail to complete follow-up as required by the protocol;
20. Pregnant or lactating women, female subjects with potential fertility but unable or unwilling to use effective contraceptive measures during the study;
21. Subjects who are participating in other clinical trials and have not yet reached the endpoints of the trial;
22. Other situations that the investigator believes are not suitable for clinical trials.

Where this trial is running

Fuzhou, Fujian and 1 other locations

• Department of Cardiovascular Surgery — Fuzhou, Fujian, China (Recruiting)
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)

Study contacts

• Study coordinator: Liang-wan Chen, M.D Ph.D

Conditions Cardiogenic Shock