Corheart 6 LVAS Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-14

Study Completion Date

2031-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of this study is to evaluate the safety and effectiveness of the Corheart 6 LVAS when used for the treatment of advanced left ventricular heart failure in a European population at 6 months post-implantation.

The secondary objective is to assess the long-term safety and effectiveness of Corheart 6 LVAS treatment.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Corheart 6 Left Ventricular Assist System Prospective, Multicenter, Single-arm Clinical Evaluation Trial

NCT05353816

End-stage Heart Failure

ACTIVE_NOT_RECRUITING NA

Corheart 6 LVAS LTFU

NCT05928273

End-stage Heart Failure

COMPLETED NA

Corheart 6 LVAS Long-term Follow-up Study

NCT06267612

Heart Failure

NOT_YET_RECRUITING NA

CorWave LVAS FIH Study

NCT06907017

Advanced Heart Failure

RECRUITING NA

REDUCE LAP-HF III Corvia Protocol 1701

NCT03191656

Heart Failure

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Refractory Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Corheart 6 LVAS

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

Group Type EXPERIMENTAL

Corheart 6 Left Ventricular Assist System

Intervention Type DEVICE

Implantation of left ventricular assist device for mechanical circulatory support

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Corheart 6 Left Ventricular Assist System

Implantation of left ventricular assist device for mechanical circulatory support

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 1\. Age ≥ 18 years and ≤ 75 years
* 2\. The patient has signed an Informed Consent Form
* 3\. Body Surface Area (BSA) ≥ 1.2 m\^2
* 4\. New York Heart Association (NYHA) Class IV
* 5\. Left Ventricular Ejection Fraction (LVEF) ≤ 25%
* 6\. Despite the optimal medical management based on current guidelines, the patient must also meet one or more of the following:
* a. Unable to exercise for HF,
* or
* if able to perform cardiopulmonary testing, with peak VO2 \<12 mL/kg/min and/or \< 50% predicted value;
* b. Progressive end-organ dysfunction (worsening renal and/or hepatic function, type II pulmonary hypertension, cardiac cachexia) due to reduced perfusion and not to inadequately low ventricular filling pressure (PCWP \> 20 mmHg and SBP \< 90 mmHg or CI \< 2.0 L/min/m2).
* c. Impella or IABP assisted;
* d. Inotrope dependent/unable to wean from inotropes.

Exclusion Criteria

* 1\. Heart failure who can be treated with other therapy options (e.g. CRT, CRT-D, etc.)
* 2\. Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients' health status.
* 3\. Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia type II.
* 4\. Platelet count \< 100,000 x 10\^3/L (\< 100,000/ml).
* 5\. Psychiatric disease/ disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and ventricular assist system management.
* 6\. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator.
* 7\. Presence of an active, uncontrolled infection.
* 8\. Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:
* a. Total bilirubin \> 51.3 μmol/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 180 days prior to enrollment, or a history of cerebrovascular disease with symptomatic (\> 70%) carotid artery stenosis
* e. Serum creatinine ≥ 265 μmol/L (3.0mg/dl) or requiring dialysis.
* f. Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration.
* 9\. Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive/ restrictive cardiomyopathy, pericardial disease, amyloidosis or giant cell myocarditis.
* 10\. Uncorrected moderate to severe aortic insufficiency without plans for correction during pump implant.
* 11\. History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) \> 5 cm in diameter.
* 12\. Uncontrollable ventricular tachyarrythmias/ ventricular fibrillation (VF).
* 13\. STEMI \<2 weeks before planned implantation.
* 14\. 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. CVP/PCWP ratio \> 0.63
* 15\. Planned Bi-VAD support prior to enrollment.
* 16\. Cardiac arrest with a history of resuscitation 1-month before inclusion, without full restoration of cognitive function.
* 17\. History of any organ transplant.
* 18\. Pre albumin \< 150 mg/L, or Albumin \< 30g/L (3 g/dL).
* 19\. Any condition other than HF that could limit survival to less than 24 months.
* 20\. Positive pregnancy test if of childbearing potential.
* 21\. Lactating mothers.
* 22\. Participation in any other clinical investigation that is likely to confound study results or affect the study.
* 23\. Patients who have been placed in an institution by court order or by order of the authorities.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No