Clinical trial NCT02156609: HeartMate PHP™ CE Mark Clinical Investigation Plan
Official title: HeartMate PHP™ CE Mark Clinical Investigation Plan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Risk Percutaneous Coronary Intervention
Keywords: HeartMate PHP
HeartMate PHP CE Mark
Percutaneous coronary intervention
PCI
Percutaneous ventricular assist
Thoratec Corporation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2014-06-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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-

Primary outcomes:
measure: Primary Endpoint
timeFrame: Post procedure or at hospital discharge (whichever is longer), 30 days post procedure
measure: Composite of Major Adverse Events (MAE)
timeFrame: Post procedure or at hospital discharge (whichever is longer), 30 days post procedure
Secondary outcomes:
measure: Secondary Endpoint
timeFrame: Post procedure or at hospital discharge (whichever is longer), 30 days post procedure
measure: Major Adverse Event Composites
timeFrame: Post procedure or at hospital discharge (whichever is longer), 30 days post procedure
Other outcomes:
Locations:
city: Bucaramanga
country: Colombia
facility: Instituto del Corazon
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Asuncion
country: Paraguay
facility: Sanatorio Italiano
city: Katowice
country: Poland
facility: Samodzielny Publiczny Szpital (The Prof. Leszka Gieca Upper-Silesian Medical Centre)
city: Krakow
country: Poland
facility: University Hospital in Krakow (John Paul II)
city: Warszawa
country: Poland
facility: The Cardinal Stefan Wyszynski Institute of Cardiology
city: Zabrze
country: Poland
facility: Slaskie Centrum Chorob Serca w Zabrzu (Silesian Center for Heart Disease)
Study officials:
affiliation: Jagiellonian University
name: Dariusz Dudek, MD
role: PRINCIPAL_INVESTIGATOR
References: