HeartMate PHP™ CE Mark Clinical Investigation Plan

NCT02156609 | Completed DMC

• 1 other identifier: PHPCEMark
• Study Type: interventional
• Target: 50
• Locations: 4 countries
• Sites: 7

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.

Conditions

High Risk Percutaneous Coronary Intervention

Keywords

HeartMate PHP; HeartMate PHP CE Mark; Percutaneous coronary intervention; PCI; Percutaneous ventricular assist; Thoratec Corporation

Outcome Measures

Primary Outcomes (2)

• Primary Endpoint

  Primary Performance Endpoint: Freedom from hemodynamic compromise during PCI procedure defined as: Mean Arterial Pressure (MAP) not falling below 60mm Hg for more than 10 minutes during the PCI procedure and additional pressor medication is not required. Primary Endpoint will be evaluated at: * Post procedure or at hospital discharge (whichever is longer) * 30 days post procedure

  Post procedure or at hospital discharge (whichever is longer), 30 days post procedure

• Composite of Major Adverse Events (MAE)

  Primary Safety Endpoint: Composite of Major Adverse Events (MAE): * device-related cardiac death, * new Q wave myocardial infarction, * surgical intervention due to device complication or malfunction, * device-related access site complication requiring intervention or device-related limb ischemia, * cerebral vascular accident (CVA), * new or worsening aortic valve insufficiency, * major bleeding complication (BARC 3 or \>), * severe hypotension Primary Endpoint will be evaluated at: * Post procedure or at hospital discharge (whichever is longer) * 30 days post procedure

  Post procedure or at hospital discharge (whichever is longer), 30 days post procedure

Secondary Outcomes (2)

• Secondary Endpoint

  Post procedure or at hospital discharge (whichever is longer), 30 days post procedure

• Major Adverse Event Composites

  Post procedure or at hospital discharge (whichever is longer), 30 days post procedure

Study Arms (1)

Percutaneous coronary intervention

EXPERIMENTAL

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

Device: Percutaneous ventricular support with the HeartMate PHP

Interventions

Percutaneous ventricular support with the HeartMate PHP 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,

Percutaneous coronary intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age.
• Patient presents with a non-emergent need for complex PCI with:
• an ejection fraction of ≤35% requiring hemodynamic support during the procedure, AND
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (7)

Instituto del Corazon

Bucaramanga, Colombia

Location

Erasmus Medical Center

Rotterdam, 3000 CA, Netherlands

Location

Sanatorio Italiano

Asunción, Paraguay

Location

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

Katowice, 40-635, Poland

Location

University Hospital in Krakow (John Paul II)

Krakow, 31-202, Poland

Location

The Cardinal Stefan Wyszynski Institute of Cardiology

Warsaw, 04-628, Poland

Location

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

Zabrze, 41-800, Poland

Location

Study Officials

• Dariusz Dudek, MD

  Jagiellonian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2014
• First Posted: June 5, 2014
• Study Start: June 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 24, 2022

Record last verified: 2022-06

Locations

PL (4); CO (1); NL (1); PA (1)