CSI Percutaneous Ventricular Assist Device (pVAD) Second in Human Study

Abbott

Status

Withdrawn

Conditions

Coronary Artery Disease

Treatments

Device: CSI pVAD System

Study type

Interventional

Funder types

Industry

Identifiers

NCT05695716

CLN-0017-P

Details and patient eligibility

About

The purpose of this study is to collect data on safety and device performance on the CSI pVAD System used to support hemodynamic stability during HR-PCIs to inform device design and finalization.

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subject is ≥18 years of age
In the investigator's opinion, the subject is capable of providing informed consent.
Subject has signed the Independent Ethics Committee (IEC) approved study Informed Consent Form (ICF) prior to any study related procedures
Subject has a life expectancy ≥1 year
Subject has a left ventricular ejection fraction (LVEF) ≥15% and ≤40%
Subject has a planned elective or urgent high risk percutaneous coronary intervention with hemodynamic support
Subject of child bearing potential has a negative pregnancy test result

Exclusion criteria

Subject has ST-Elevation Myocardial Infarction (STEMI) within 30 days prior to study procedure based on criteria in SCAI definition
Subject has NSTEMI with cardiac enzymes that are not trending downward within 30 days prior to study procedure
Subject with RV failure (defined as reduced RV function on imaging and evidence of increased CVP >18 mmHg)
Subject with history of cardiac arrest within 30 days prior to study procedure requiring cardiopulmonary resuscitation OR any history of cardiac arrest with impairment in mental status, cognition or any global or functional neurological deficit
Subject is in cardiogenic shock (defined as systolic BP <90 mmHg, cardiac index <2.1 and/or evidence of impaired end organ perfusion) that is not responsive to fluid infusion or requiring any inotropic or pressor support
Subject received any pressors or inotropes within 24 hours prior to the start of the study procedure
Subject has evidence of current or prior endocarditis
Subject with active myocarditis
Subject had a deep vein thrombosis (DVT) or pulmonary embolism (PE) within 6 months prior to study procedure
Subject had a stroke or TIA within 6 months prior to study procedure
Subject had previous CABG within 6 months prior to study procedure
Subject had coronary intervention within 30 days prior to study procedure
Subject has a coronary intervention planned within 30 days post procedure
Subject has presence of left ventricular (LV) mural thrombus
Subject has history of valve replacement or repair (e.g., MitraClipTM) including transcatheter edge to edge repair (TEER)
Subject has significant mitral valve disease (defined as mitral regurgitation greater than moderate, grade ≥2+ by echocardiogram (ECHO), mitral stenosis with MVA <1.5 cm2) or has evidence of structural damage to the chordae tendineae or valve
Subject has significant aortic valve disease (defined as aortic stenosis (valve area ≤1.5 cm2 or moderate or severe aortic regurgitation (grade ≥2+ by ECHO))
Subject with atrial fibrillation present at the time of enrollment or any time prior to RHC or CSI pVAD device placement
Subject has sustained tachycardia with heart rate over 120 BPM
Subject has sustained ventricular tachycardia either pre- or during intervention
Subject has severe pulmonary hypertension, defined as mean pulmonary artery pressure ≥40 mmHg
Subject has presence of an aneurysm or dissection along vascular delivery path including:
1. Abdominal aortic aneurysm 4.0 cm or greater, OR
2. Significant descending thoracic aortic aneurysm greater than 4.5 cm, OR
3. Any dissection of the ascending, transverse, or descending aorta
Subject has severe peripheral vascular disease that will preclude the use of a 12Fr access sheath, which is required for the insertion of the CSI pVAD catheter
Subject has severe aortic tortuosity
Subject has severe aortic calcification that may preclude appropriate placement of the CSI pVAD device
Subject's vasculature will not tolerate a right heart catheterization (RHC)
Subject has chronic renal dysfunction defined by either:
1. Serum creatinine ≥ 2.5 mg/dl AND/OR
2. Requires hemodialysis
Subject has liver dysfunction with either:
1. Elevation of liver enzymes and bilirubin levels to ≥ 3X ULN OR
2. Internationalized Normalized Ratio (INR) ≥ 2 OR
3. Lactate dehydrogenase (LDH) > 2.5X ULN
Subject has uncorrectable abnormal coagulation parameters defined as either:
1. Platelet count ≤75,000 per μL OR
2. INR ≥2.0 or
Subject has history of heparin induced thrombocytopenia
Subject has history of bleeding diathesis or known coagulopathy, any recent GU or GI bleed within 30 days prior to study procedure or will refuse blood transfusions
Subject has anemia (hemoglobin <10.0 g/dL) or polycythemia/hypovolemia (hemoglobin >16.5 g/dL)
Subject requires, or, in the clinical judgement of the investigators may need, long term support (>6 hours) with a commercially available mechanical circulatory support (MCS) device
Subject was on any mechanical cardiac support device at any time within 14 days prior to the study procedure.
Subject has an active systemic infection requiring oral or intravenous antibiotics, or elevated temperature or white blood cell count that may be due to infection
Subject has been diagnosed with COVID ≤10 days prior to study procedure or is excluded due to COVID based on institution or other (e.g., CDC) guidelines
Subject has an allergy or intolerance to ionic and nonionic contrast media, anticoagulants, or antiplatelet therapy drugs that cannot be adequately premedicated
Subject has an allergy or intolerance to CSI pVAD System components
Subject is pregnant
Subject is currently participating or plans to participate in another investigational drug- or device trial that may affect any of this study's endpoints
Subject has any other anatomical-, clinical-, social-, etc. characteristics that preclude the subject from being a candidate for the study
Subject has any contradiction listed in the current IFU