HeartMate PHP™ CE Mark Clinical Investigation Plan

NCT ID: NCT02156609

Last Updated: 2022-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-12-31

Brief Summary

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.

Detailed 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).

Conditions

High Risk Percutaneous Coronary Intervention

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Percutaneous coronary intervention

Percutaneous ventricular support with the HeartMate PHP during high risk percutaneous coronary intervention

Group Type: EXPERIMENTAL

Percutaneous ventricular support with the HeartMate PHP

Intervention Type: DEVICE

The HeartMate PHP device will be inserted percutaneously prior to the start of high risk coronary interventions (complex disease, reduced ejection fraction, etc.) to provide hemodynamic support,

Interventions

Percutaneous ventricular support with the HeartMate PHP

The HeartMate PHP device will be inserted percutaneously prior to the start of high risk coronary interventions (complex disease, reduced ejection fraction, etc.) to provide hemodynamic support,

Intervention Type: DEVICE

Eligibility Criteria

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-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dariusz Dudek, MD

Role: PRINCIPAL_INVESTIGATOR

Jagiellonian University

Locations

Instituto del Corazon

Bucaramanga, , Colombia

Erasmus Medical Center

Rotterdam, , Netherlands

Sanatorio Italiano

Asunción, , Paraguay

Samodzielny Publiczny Szpital (The Prof. Leszka Gieca Upper-Silesian Medical Centre)

Katowice, , Poland

University Hospital in Krakow (John Paul II)

Krakow, , Poland

The Cardinal Stefan Wyszynski Institute of Cardiology

Warsaw, , Poland

Slaskie Centrum Chorob Serca w Zabrzu (Silesian Center for Heart Disease)

Zabrze, , Poland

Countries

Colombia; Netherlands; Paraguay; Poland

Other Identifiers

PHPCEMark

Identifier Type: -

Identifier Source: org_study_id