HeartMate PHP™ CE Mark Clinical Investigation Plan (HM PHP CE Mark)

Abbott

Status

Completed

Conditions

High Risk Percutaneous Coronary Intervention

Treatments

Device: Percutaneous ventricular support with the HeartMate PHP

Study type

Interventional

Funder types

Industry

Identifiers

NCT02156609

PHPCEMark

Details and patient eligibility

About

The HeartMate PHP is a catheter-based pump designed to provide partial left heart circulatory support. The study will assess the safety and performance of the HeartMate PHP in supporting patients who are hemodynamically unstable, or at risk of being hemodynamically unstable, while undergoing percutaneous coronary interventions (PCI), such as coronary stent placement.

Full description

The HeartMate PHP (percutaneous heart pump) is a catheter-based axial flow pump designed to provide partial left ventricular circulatory support. The primary objective of this prospective, nonrandomized, multi-center, open-label trial is to assess the safety and performance of the HeartMate PHP in supporting patients who are hemodynamically unstable, or at risk of being hemodynamically unstable, while undergoing percutaneous coronary interventions (PCI).

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

At least 18 years of age.
Patient presents with a non-emergent need for complex PCI with:
1. an ejection fraction of ≤35% requiring hemodynamic support during the procedure, AND
2. the heart team has determined that the patient is not an optimal surgical candidate, OR the patient elects not to undergo surgery
Written, signed, and dated informed consent

Exclusion criteria

Emergent PCI
ST elevation myocardial infarction within 7 days of procedure
Cardiac arrest within 7 days of procedure requiring CPR or defibrillation
Hemodynamic support with the HeartMate PHP post-PCI is anticipated
Cardiogenic shock (SBP <90 mmHg for >1 hour with either cool clammy skin OR oliguria OR altered sensorium OR cardiac index <2.2 L/min/m2)
Mural thrombus in the left ventricle
History of aortic valve replacement
Documented presence of aortic stenosis (orifice area of 1.5cm2 or less)
Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as 2 or higher)
Severe peripheral vascular disease
Abnormalities of the aorta that would preclude surgery, including aneurysms and significant tortuosity or calcifications
Planned use of rotablator or atherectomy during the procedure
Serum creatinine > 3.5mg/dL within 7 days of procedure
Liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3x ULN or INR (Internationalized Normalized Ratio) ≥2
Uncorrectable abnormal coagulation parameters
Active systemic infection requiring treatment with antibiotics
Clinically relevant stroke or TIA within 3 months of procedure. Patients with suspected stroke or TIA within 3 months of procedure must have documented absence of neurological infarction
Uncontrollable allergy or intolerance to heparin, aspirin, clopidogrel, ionic and nonionic contrast media, or any other potentially required anticoagulants or antiplatelet therapy drugs
History of heparin induced thrombocytopenia
Patient is pregnant or planning to become pregnant during the study period
Participation in another clinical study of an investigational drug or device that has not met its primary endpoint-