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Corheart 6 VAS Study

Primary Purpose

Refractory Heart Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Corheart 6 Ventricular Assist System
Sponsored by
Shenzhen Core Medical Technology CO.,LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Heart Failure focused on measuring advanced heart failure; ventricular assist system;

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1. Age ≥ 18 years and ≤ 75 years 2. BSA ≥ 1.0 m^2 3. NYHA III or IV OR ACC/AHA Stage D 4. LVEF ≤ 30% 5. Patients must also meet one or more of the following: CI ≤ 2.2 L/min/m², while on Optimal Medical and Device Management, based on current heart failure practice guidelines; OR Impella or IABP assisted patient (based on doctors' judgement); OR Inotrope dependent/unable to wean from inotropes; OR Listed for heart transplantation. Exclusion Criteria: 1. Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients' health status. 2. Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia type II. 3. Platelet count < 100,000 x 10^3/L (< 100,000/ml). 4. Psychiatric disease/ disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and ventricular assist system management. 5. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator. 6. Presence of an active, uncontrolled infection. 7. Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure: a. Total bilirubin > 51.3 umol/L (3.0 mg/dl), ischemic hepatitis, or biopsy proven liver cirrhosis, or clinically Child-Pugh B and C score. b. History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC < 0.7, or FEV1 < 50% predicted. c. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention. d. History of stroke within 90 days prior to enrollment, or a history of cerebrovascular disease with significant (> 80%) carotid artery stenosis e. Serum creatinine ≥ 265umol/L (3.0mg/dl) or requiring dialysis. f. Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration. 8. Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive/ restrictive cardiomyopathy, pericardial disease, amyloidosis or giant cell myocarditis. 9. Uncorrected moderate to severe aortic insufficiency without plans for correction during pump implant. 10. History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) > 5 cm in diameter. 11. Uncontrollable ventricular tachyarrythmias/ ventricular fibrillation (VF). 12. STEMI <2 weeks before planned implantation. 13. Right ventricular failure as defined by one or more of the following: a. severe depressed RV function in echocardiography b. TAPSE < 1.0 cm c. PCWP/CVP <0.63 14. Planned Bi-VAD support prior to enrollment. 15. History of any organ transplant. 16. Pre albumin < 150 mg/L, or Albumin < 30g/L (3 g/dL). 17. Any condition other than HF that could limit survival to less than 24 months. 18. Positive pregnancy test if of childbearing potential. 19. Lactating mothers. 20. Participation in any other clinical investigation that is likely to confound study results or affect the study.

Sites / Locations

  • Deutsches Herzzentrum der Charite

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Corheart 6 VAS

Arm Description

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

Outcomes

Primary Outcome Measures

Survival
At 6 months post-implantation, composite of survival to transplant, recovery or VAS support free of disabling stroke (Modified Rankin Score > 3) or re-operation to replace the pump due to pump failure.

Secondary Outcome Measures

Survival
Overall survival of patients
Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms.
Quality of Life as measured by the EuroQoL-5D-5L (EQ-5D-5L)
The scores from the 5 dimensions are summed for the total score which ranges from 5 to 25 with higher scores indicating more problems and a worse quality of life.
Functional status as measured by the Six Minute Walk Test (6MWT)
The more meters a patient can walk over baseline indicates improvement in functional status.
Functional status as measured by the New York Heart Association (NYHA) Classification
NYHA class categorizes patients by the severity of their heart failure symptoms. As the class increases, the degree of symptoms is more severe indicating worse functional status.
Adverse Events
Frequency and incidence of all anticipated Adverse Event.

Full Information

First Posted
April 24, 2023
Last Updated
June 6, 2023
Sponsor
Shenzhen Core Medical Technology CO.,LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT05876000
Brief Title
Corheart 6 VAS Study
Official Title
Prospective Multi-Center Single-Arm Study for Evaluating the Corheart 6 Ventricular Assist System
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
December 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Core Medical Technology CO.,LTD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is to evaluate the safety and effectiveness of the Corheart 6 Ventricular Assist System (Corheart 6 VAS) when used for the treatment of advanced refractory heart failure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Heart Failure
Keywords
advanced heart failure; ventricular assist system;

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Corheart 6 VAS
Arm Type
Experimental
Arm Description
Corheart 6 Ventricular Assist System (Corheart 6 VAS) to be used on patients with advanced refractory heart failure.
Intervention Type
Device
Intervention Name(s)
Corheart 6 Ventricular Assist System
Intervention Description
Implantation of ventricular assist device for hemodynamic support
Primary Outcome Measure Information:
Title
Survival
Description
At 6 months post-implantation, composite of survival to transplant, recovery or VAS support free of disabling stroke (Modified Rankin Score > 3) or re-operation to replace the pump due to pump failure.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Survival
Description
Overall survival of patients
Time Frame
Year 1, Year 2, Year 3, Year 4, Year 5
Title
Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
Scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms.
Time Frame
Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Title
Quality of Life as measured by the EuroQoL-5D-5L (EQ-5D-5L)
Description
The scores from the 5 dimensions are summed for the total score which ranges from 5 to 25 with higher scores indicating more problems and a worse quality of life.
Time Frame
Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Title
Functional status as measured by the Six Minute Walk Test (6MWT)
Description
The more meters a patient can walk over baseline indicates improvement in functional status.
Time Frame
Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Title
Functional status as measured by the New York Heart Association (NYHA) Classification
Description
NYHA class categorizes patients by the severity of their heart failure symptoms. As the class increases, the degree of symptoms is more severe indicating worse functional status.
Time Frame
Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Title
Adverse Events
Description
Frequency and incidence of all anticipated Adverse Event.
Time Frame
As they occurred, from Baseline to Year 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years and ≤ 75 years 2. BSA ≥ 1.0 m^2 3. NYHA III or IV OR ACC/AHA Stage D 4. LVEF ≤ 30% 5. Patients must also meet one or more of the following: CI ≤ 2.2 L/min/m², while on Optimal Medical and Device Management, based on current heart failure practice guidelines; OR Impella or IABP assisted patient (based on doctors' judgement); OR Inotrope dependent/unable to wean from inotropes; OR Listed for heart transplantation. Exclusion Criteria: 1. Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients' health status. 2. Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia type II. 3. Platelet count < 100,000 x 10^3/L (< 100,000/ml). 4. Psychiatric disease/ disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and ventricular assist system management. 5. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator. 6. Presence of an active, uncontrolled infection. 7. Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure: a. Total bilirubin > 51.3 umol/L (3.0 mg/dl), ischemic hepatitis, or biopsy proven liver cirrhosis, or clinically Child-Pugh B and C score. b. History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC < 0.7, or FEV1 < 50% predicted. c. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention. d. History of stroke within 90 days prior to enrollment, or a history of cerebrovascular disease with significant (> 80%) carotid artery stenosis e. Serum creatinine ≥ 265umol/L (3.0mg/dl) or requiring dialysis. f. Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration. 8. Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive/ restrictive cardiomyopathy, pericardial disease, amyloidosis or giant cell myocarditis. 9. Uncorrected moderate to severe aortic insufficiency without plans for correction during pump implant. 10. History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) > 5 cm in diameter. 11. Uncontrollable ventricular tachyarrythmias/ ventricular fibrillation (VF). 12. STEMI <2 weeks before planned implantation. 13. Right ventricular failure as defined by one or more of the following: a. severe depressed RV function in echocardiography b. TAPSE < 1.0 cm c. PCWP/CVP <0.63 14. Planned Bi-VAD support prior to enrollment. 15. History of any organ transplant. 16. Pre albumin < 150 mg/L, or Albumin < 30g/L (3 g/dL). 17. Any condition other than HF that could limit survival to less than 24 months. 18. Positive pregnancy test if of childbearing potential. 19. Lactating mothers. 20. Participation in any other clinical investigation that is likely to confound study results or affect the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoli Shi
Phone
+86 13418601356
Email
shixiaoli@coretechmed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evgenij V Potapov
Organizational Affiliation
Deutsches Herzzentrum der Charite
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deutsches Herzzentrum der Charite
City
Berlin
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evgenij V Potapov
Phone
+49 30 4593 2065
Email
evgenij.potapov@dhzc-charite.de

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
At this moment the IPD is not yet available for access and will be updated when it is ready.

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Corheart 6 VAS Study

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