Corheart 6 LVAS Long-term Follow-up Study

NCT06267612 | Not Yet Recruiting

• 1 other identifier: KY20231109-11
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical study is to explore the long-term efficacy and safety of the Corheart 6 Left Ventricular Assist System (LVAS) as a treatment for patients with advanced heart failure. The study will be a single-arm, prospective, single-center, non-blinded, and non-randomized study with a follow-up duration of five years.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Device implantaion success rate at 24 months post-implantation

  Device implantation success is defined as: * A. Electively transplanted or explanted prior to 24 months or * B. Alive at 24 months, and * I. Have not experienced a stroke with a modified Rankin Score \> 3, and * II. Have not received a device replacement or exchange due to a device malfunction, and * III. Have not received an urgent transplant due to a device malfunction.

  Up to 24 months post-implantation

Secondary Outcomes (10)

• Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23)

  Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation

• Quality of Life as measured by the EuroQoL-5D-5L (EQ-5D-5L) questionnaire

  Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation

• Functional status as measured by the Six Minute Walk Test (6MWT)

  Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation

• Functional status as measured by the New York Heart Association (NYHA) Classification

  Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation

• Stroke severity as assessed with the National Institutes of Health Stroke Scale (NIHSS) score

  Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation, and as a stoke event occurs, from baseline to 24 months post-implantation

Study Arms (1)

Corheart 6 LVAS

EXPERIMENTAL

Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) to be used on patients with advanced heart failure.

Device: Corheart 6 Left Ventricular Assist System

Interventions

Corheart 6 Left Ventricular Assist System DEVICE

Implantation of left ventricular assist device for hemodynamic support

Corheart 6 LVAS

Eligibility Criteria

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

You may qualify if:

• \. Age ≥ 18 years.
• \. The patient or legal representative is willing to participate in the study and offers informed consent.
• \. Body surface area (BSA) ≥ 1.0 m\^2.
• \. Females of childbearing age must agree to use adequate contraception.
• \. Patients with NYHA Class IV heart failure symptoms who have failed to be reversed by standardized treatment with oral anti-heart failure drugs.
• \. Left Ventricular Ejection Fraction (LVEF) ≤ 35%, 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 (optional), and pulmonary capillary wedge pressure \> 18mmHg (optional).

You may not qualify if:

• \. Etiology of heart failure due to or associated with uncorrected thyroid disease, obstructive hypertrophic cardiomyopathy, or pericardial disease.
• \. Presence of an active, uncontrolled infection confirmed by a combination of clinical symptoms and laboratory tests.
• \. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator.
• \. Intolerance to anticoagulant or antiplatelet therapies or any other peri/postoperative therapy the investigator will require based on the patient's health status.
• \. Patients require bi-ventricular assist device support.
• \. Pregnancy.
• \. 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.
• \. History of any organ transplantation.
• \. Presence of uncorrected thrombocytopenia or severe coagulopathy, such as diffuse intravascular coagulation.
• \. TBIL (total bilirubin) \> 3.0 mg/dL within 48 hours prior to implantation.
• \. Serum creatinine (SCr) \> 3.0 mg/dL within 48 hours prior to implantation or may require dialysis.
• \. Presence of severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease or a diagnosis of primary pulmonary hypertension.
• \. Presence of pulmonary embolism within 3 weeks prior to implantation.
• \. Pulmonary artery systolic pressure exceeds 60mmHg, combined with at least one of the following 2 parameters demonstrating that pulmonary vascular resistance did not respond to drug therapy:
• a. Pulmonary vascular resistance greater than 8 wood units.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Zhibing Qiu

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhibing Qiu

CONTACT

025-52271064; qiuzhibing2009@163.com

Study Design

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

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 20, 2024
• Study Start: February 10, 2024
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)