Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05353816
Other study ID # COREMED_LVAS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 26, 2022
Est. completion date October 8, 2022

Study information

Verified date February 2024
Source Shenzhen Core Medical Technology CO.,LTD.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is to evaluate the safety and effectiveness of the Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) used for the treatment of end-stage heart failure.


Description:

The Corheart 6 Left Ventricular Assist System (also called "the Corheart 6 LVAS", or "the Corheart 6") is developed and manufactured by Shenzhen Core Medical Technology Co., Ltd. It is indicated for providing short-term and long-term mechanical circulatory support for patients with end-stage heart failure. This prospective, multi-center, and single-arm trial evaluates the safety and effectiveness of the device in treating patients with end-stage heart failure. 50 patients from 12 investigational sites will be enrolled for Corheart 6 VAS implantation and followed for 3 months post-implantation. The primary study endpoint is the success rate of device implantation at 3 months post-implantation. All adverse events will be adjudicated by an independent Clinical Events Committee (CEC).


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date October 8, 2022
Est. primary completion date October 8, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - (1) Age = 18 years. - (2) The patient or legal representative has signed the Informed Consent Form (ICF). - (3) Body Surface Area (BSA) = 1.0 m^2. - (4) Females of childbearing age must agree to use adequate contraception. - (5) Patients with NYHA Class IV heart failure symptoms who have failed to be reversed by previous standardized oral treatment with anti-heart failure drugs (ACEI, beta-blockers, and diuretics). - (6) Left Ventricular Ejection Fraction (LVEF) = 30%, and at least one of the following conditions occurs: - a. Fail to be reversed by or be weaned from intra-aortic balloon pump (IABP), extracorporeal membrane oxygenator (ECMO), or other short-term mechanical circulatory support; - b. Rely on continuous intravenous administration of one or more vasoactive or inotropic drugs; - c. Meeting the diagnostic criteria of cardiogenic shock: blood pressure < 90/60mmHg, cardiac index < 2.0 L/min/m^2, and pulmonary capillary wedge pressure > 18mmHg. Exclusion Criteria: - (1) Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy pericardial disease, amyloidosis, or restrictive cardiomyopathy. - (2) Presence of an active, uncontrolled infection confirmed by a combination of clinical symptoms and laboratory tests. - (3) Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator. - (4) Intolerance to anticoagulant or antiplatelet therapies or any other peri/postoperative therapy the investigator will require based on the patient's health status. - (5) Patients require bi-ventricular assist device support. - (6) Pregnancy. - (7) Presence of moderate to severe aortic insufficiency or a history of the mechanical aortic valve that will not be converted to a bioprosthesis or oversewn at the time of implantation. - (8) History of any organ transplantation. - (9) Presence of uncorrected thrombocytopenia or severe coagulopathy, such as diffuse intravascular coagulation. - (10) TBIL (total bilirubin) > 3.0 mg/dL, serum creatinine (SCr) > 3.0 mg/dL within 48 hours prior to LVAD implantation surgery or may require dialysis. - (11) History of severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease or a diagnosis of primary pulmonary hypertension. - (12) Pulmonary embolism and pulmonary artery systolic blood pressure exceeding 60mmHg within 3 weeks prior to enrollment combined with at least one of the following 2 parameters demonstrating that pulmonary vascular resistance did not respond to drug therapy: Pulmonary vascular resistance greater than 8 wood units; The transpulmonary differential pressure exceeds 20mmHg. - (13) Established and untreated abdominal or thoracic aortic aneurysm > 5cm in diameter. - (14) Presence of severe peripheral vascular disease with resting pain or extremity ulceration. - (15) Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and Left Ventricular Assist System management, or brain death from various causes. - (16) Expect to live less than 1 year due to malignant tumor or other diseases. - (17) Participation in any other clinical trials that may influence the results of this study. - (18) Other circumstances that are unforeseen and determined by the researcher to be unsuitable.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Corheart 6 Left Ventricular Assist System
Implantation of the Corheart 6 Left Ventricular Assist Device for mechanical circulatory support.

Locations

Country Name City State
China Fuwai Hospital, Chinese Academy of Medical Sciences(CAMS) Beijing Beijing
China The Second XIANGYA Hospital Of Central South University Changsha Hunan
China Fujian Medical University Union Hospital Fuzhou Fujian
China Guangdong Provincial People's Hospital Guangzhou Guangdong
China Nanjing First Hospital Nanjing Jiangsu
China Zhongshan Hospital, Fudan University Shanghai Shanghai
China The First Affiliated Hospital of Soochow University Suzhou Jiangsu
China Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei
China Xijing Hospital of Air Force Medical University Xi'an Shanxi
China People's Hospital of Xinjiang Uygur Autonomous Region Xinjiang Xinjiang
China Fuwai Central China Cardiovascular Hospital Zhengzhou Hunan

Sponsors (1)

Lead Sponsor Collaborator
Shenzhen Core Medical Technology CO.,LTD.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The success rate of device implantation at 3 months. The success rate of device implantation at 3 months post-implantation.
Device implantation success will be met when a patient is still alive on device support, free of disabling stroke (modified Rankin Scale (mRS) > 3), and does not have the device replaced or removed due to device deficiency at 3 months post-implantation.
The modified Rankin Scale is a tool used to assess functional disability or dependence in daily activities following a stroke or other neurological condition. It ranges from 0 (No observed neurological symptoms) to 6 (dead). Higher scores indicate more severe functional impairment.
Up to 3 months post-implantation.
Secondary Functional status as measured by the New York Heart Association (NYHA) Classification The NYHA (New York Heart Association) Functional Classification is a tool used to assess the severity of heart failure symptoms. It categorizes patients into one of four classes based on their level of activity limitation and symptoms. Class I represents no limitation of physical activity, while Class IV indicates severe limitations even at rest. Baseline, at hospital discharge (assessed up to 5 days), and at 3 months post-implantation.
Secondary Quality of Life as measured by the EuroQoL-5D-3L (EQ-5D-3L) questionnaire The EQ-5D-3L assesses health-related quality of life across five dimensions with three severity levels each. The scores from the 5 dimensions are summed for the total score which ranges from 5 to 15 with higher scores indicating more problems and a worse quality of life. Baseline, at hospital discharge (assessed up to 5 days), and at 3 months post-implantation.
Secondary Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ-23). The Kansas City Cardiomyopathy Questionnaire (KCCQ-3) evaluates heart failure patients' health status, including symptoms, physical limitations, social limitations, self-efficacy, and quality of life. Scores range from 0 to 100, with higher scores indicating better health-related quality of life. Baseline, at hospital discharge (assessed up to 5 days), and at 3 months post-implantation.
Secondary Functional status as measured by the Six Minute Walk Test (6MWT) The 6-Minute Walk Test (6MWT) assesses functional capacity and endurance by measuring the distance walked in six minutes. Results vary based on age, gender, and disease severity. Generally, greater distances indicate better functional capacity and endurance. Baseline, at hospital discharge (assessed up to 5 days), and at 3 months post-implantation.
Secondary Stroke severity as assessed with the National Institutes of Health Stroke Scale (NIHSS) score. The National Institutes of Health Stroke Scale measures stroke-related neurological deficits across various domains. Scores range from 0 to 42, with higher scores indicating more severe neurological impairment. Lower scores correlate with better neurological function. From baseline to 3 months post-implantation.
Secondary Stroke severity as assessed by the modified Rankin Scale (mRS) score The modified Rankin Scale is a tool used to assess functional disability or dependence in daily activities following a stroke or other neurological condition. It ranges from 0 (No observed neurological symptoms) to 6 (dead). Higher scores indicate more severe functional impairment. From baseline to 3 months post-implantation.
Secondary Adverse Events Frequency and incidence of all anticipated adverse events. From baseline to 3 months post-implantation.
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06063811 - Ventricular Tachycardia Ablation in LVAD Patients
Withdrawn NCT04782245 - Acute Reno-Cardiac Action of Dapagliflozin In Advanced Heart Failure Patients on Heart Transplant Waiting List Phase 2
Active, not recruiting NCT04351945 - Endocrine Changes and Their Correction in Heart and Lung Transplant Recipients and Donors
Recruiting NCT03966313 - Perioperative Modification of Hemostasis During Ventricular Assist Device Implantation
Recruiting NCT02592499 - Swedish Evaluation of Left Ventricular Assist Device as Permanent Treatment in End-stage Heart Failure N/A
Active, not recruiting NCT00490321 - VentrAssistTM LVAD for the Treatment of Advanced Heart Failure - Destination Therapy Phase 3
Active, not recruiting NCT00483197 - VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Pivotal Trial Phase 3
Completed NCT04543747 - Mechanical Circulatory Support Korea Post Market Surveillance Study (PMS)
Recruiting NCT04293575 - Transcatheter Mitral Valve Repair as Bridge Therapy to Heart Transplantation
Recruiting NCT04641416 - Noninvasive Cardiovascular Diagnosis of Patients With Fully Magnetically Levitated Blood Pumps
Completed NCT00490347 - VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Feasibility Trial Phase 2
Suspended NCT04117295 - Carmat TAH Early Feasibility Study N/A
Completed NCT04480151 - ECLS Versus IMPELLA™ as Bridge to LVAD (ECI-BLAD)
Recruiting NCT04205760 - Preoperative Nutritional Optimization and Physical Exercise for Patients Scheduled for Elective Implantation for a Left-Ventricular Assist Device Phase 3
Recruiting NCT06345521 - Etablishment of Follow-up System and End-Stage Heart Registration Platform for Pediatric Heart Failure
Recruiting NCT04768322 - LVAD Versus GDMT in Ambulatory Advanced Heart Failure Patients N/A
Completed NCT02248974 - Development & Testing of a Decision Aid for LVAD Placement N/A
Completed NCT06152562 - Evaluation of Platelet Therapy Response in Left Ventricular Assist Device Patients
Completed NCT05928273 - Corheart 6 LVAS LTFU N/A
Recruiting NCT04951999 - AssocIation of PULSatility and Occurrence of Complications Related to Mechanically Assisted Circulatory Support N/A