An Interventional Left Ventricular Assist System for Cardiogenic Shock

NCT06127927 | Recruiting

• 1 other identifier: A202301
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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. has developed an interventional left ventricular assist system. The test device was tested in preclinical animals It has shown good effectiveness and safety. Through the implementation of this clinical trial, the interventional left ventricular assist system The safety and effectiveness of the system for hemodynamic support in patients with cardiogenic shock have led to further development of this product in the country.

Conditions

Cardiogenic Shock

Outcome Measures

Primary Outcomes (2)

• Survival rate of subjects at discharge or 30 days after weaning from ventilator (whichever is longer)

  Survival was defined as recovery of cardiac function or survival to bridging therapy; Recovery of cardiac function was defined as no need for any mechanical support or IABP assistance 30 days after removal of the invasive left ventricular assist system or at discharge (whichever was longer). Survival to bridging therapy was defined as survival to the induction of anesthesia for heart transplantation or placement of an implantable ventricular assist device.

  30days

• The incidence of major adverse events at discharge or 30 days after weaning (whichever is longer)

  Major adverse events included death and stroke.

  30days

Secondary Outcomes (2)

• hemodynamic indicators

  30days

• Successful device placement and technical success

  30days

Study Arms (2)

Interventional Left Ventricular Assist System Pre-trial

EXPERIMENTAL

The design of the first phase pre-trial clinical study will involve a total of 6 subjects. The survival rate of subjects before discharge or 30 days after weaning was the main effectiveness evaluation indicator, and the safety and effectiveness of the test device were preliminarily evaluated. All SAE events during the study will be reviewed by CEC experts. According to the expert review opinions, if no unexpected serious complications and product defects are found, the Formal Research phase will be started.

Device: Interventional Left Ventricular Assist System

Interventional Left Ventricular Assist System Formal Research

EXPERIMENTAL

A formal clinical trial to evaluate the effectiveness and safety of interventional left ventricular assist system for hemodynamic support in patients with cardiogenic shock through a prospective, multicenter, single-group target value study.The total number of patients enrolled in this study is planned to be 54. This sample size is calculated according to statistical principles, combining the research hypothesis and the estimate of the expected level of efficacy. The sample size calculation is based on the main efficacy index and the main safety index. Since it is set according to the common evaluation index, the sample size is calculated for the two main evaluation indicators separately, and the largest one is used as the final sample size of this trial.

Device: Interventional Left Ventricular Assist System

Interventions

Interventional Left Ventricular Assist System DEVICE

Interventional left ventricular assist system for cardiogenic shock patients

Interventional Left Ventricular Assist System Formal Research; Interventional Left Ventricular Assist System Pre-trial

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 is still evidence of tissue hypoperfusion;
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (2)

Department of Cardiovascular Surgery

Fuzhou, Fujian, 350001, China

RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Liang-wan Chen, M.D Ph.D

  Fujian Medical University Union Hospital

  STUDY CHAIR

Central Study Contacts

Liang-wan Chen, M.D Ph.D

CONTACT

+8613358255333; chenliangwan@tom.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 13, 2023
• Study Start: November 8, 2023
• Primary Completion: November 8, 2025
• Study Completion: December 8, 2025
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)