HM PHP CE Mark: HeartMate PHP™ CE Mark Clinical Investigation Plan

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02156609
• Collaborator: (none)
• Enrollment: 50
• Locations: 7
• Arm: 1
• Duration (Months): 18
• Patients Per Site: 7.1
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
High Risk Percutaneous Coronary Intervention	Device: Percutaneous ventricular support with the HeartMate PHP	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: HeartMate PHP™ CE Mark Clinical Investigation Plan
• Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Percutaneous coronary intervention Percutaneous ventricular support with the HeartMate PHP during high risk percutaneous coronary intervention	Device: 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,

Outcome Measures

Primary Outcome Measures

1. Primary Endpoint [Post procedure or at hospital discharge (whichever is longer), 30 days post procedure]

   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

2. Composite of Major Adverse Events (MAE) [Post procedure or at hospital discharge (whichever is longer), 30 days post procedure]

   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

Secondary Outcome Measures

1. Secondary Endpoint [Post procedure or at hospital discharge (whichever is longer), 30 days post procedure]

   Efficacy of hemodynamic support as measured by: Maximal decrease in cardiac power output (CPO) from baseline Changes in central venous pressure from baseline (CVP) Changes in pulmonary artery pressure from baseline (PAP) Changes in pulmonary capillary wedge pressure from baseline (PCWP) Changes in cardiac output from baseline (CO) Changes in cardiac index from baseline (CI)

2. Major Adverse Event Composites [Post procedure or at hospital discharge (whichever is longer), 30 days post procedure]

   Individual components of the major adverse event composites

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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-

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto del Corazon	Bucaramanga		Colombia
2	Erasmus Medical Center	Rotterdam		Netherlands	3000 CA
3	Sanatorio Italiano	Asuncion		Paraguay
4	Samodzielny Publiczny Szpital (The Prof. Leszka Gieca Upper-Silesian Medical Centre)	Katowice		Poland	40-635
5	University Hospital in Krakow (John Paul II)	Krakow		Poland	31-202
6	The Cardinal Stefan Wyszynski Institute of Cardiology	Warszawa		Poland	04-628
7	Slaskie Centrum Chorob Serca w Zabrzu (Silesian Center for Heart Disease)	Zabrze		Poland	41-800

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Dariusz Dudek, MD, Jagiellonian University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT02156609
• Other Study ID Numbers: PHPCEMark
• First Posted: Jun 5, 2014
• Last Update Posted: Jun 24, 2022
• Last Verified: Jun 1, 2022

• Keywords provided by Abbott Medical Devices: HeartMate PHP; HeartMate PHP CE Mark; Percutaneous coronary intervention; PCI; Percutaneous ventricular assist; Thoratec Corporation

Study Results

No Results Posted as of Jun 24, 2022