Clinical trial NCT04219618: The Left Ventricular Assist Device (LVAD) Off or On Pump Implantation Study
Official title: The Left Ventricular Assist Device Off or On Pump Implantation Study: A Single-center Randomized Trial (LVAD-ON-OFF)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
LVAD
Keywords: LVAD
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare adverse events after off-pump LVAD surgery or on-pump LVAD surgery.


Eligibility criteria: Inclusion Criteria:

* The patient has had a diagnosis of end stage heart failure, New York Heart association (NYHA) class III or IV HF for a minimum of 90 days prior to screening.
* The patient has guideline-directed medical therapy according to American College of Cardiology(ACC)/American Heart Association (AHA)/European Society of Cardiology(ESC) heart failure(HF) guidelines
* The patient has an Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) score of 1-3.
* Left ventricular assist device (LVAD) placement is intended as a bridge to transplant (BTT) or destination therapy (DT) with either HeartWare Ventricular Assist Device (HVAD) or HeartMate III LVAD.
* The patient is able to sign informed consent form and Release of Medical Information Form.
* The patients is willing and able to participate in scheduled follow-up appointments.

Exclusion Criteria:

* The patient requires concomitant surgery for left ventricular or atrial appendage closure or the patient has severe aortic insufficiency, mitral stenosis, or severe tricuspid regurgitation.
* The patient has an intracardiac thrombus or other mass diagnosed by echocardiography, left ventriculogram, or other imaging.
* Planned insertion of right ventricular(RV) support device (either temporary or permanent).
* The patient has suffered an acute cardiovascular event such as acute coronary syndrome (ST elevation myocardial infarction (STEMI) or Non-ST elevation myocardial infarction (NSTEMI), or unstable angina, or underwent any cardiac surgery or interventional cardiac or peripheral vascular procedure within 30 days prior to LVAD implantation.
* The patient has had ischemic or hemorrhagic stroke as diagnosed by CT or MRI within 90 days prior to study enrollment.
* The patient had prior heart or other organ transplantation, or surgically implanted LVAD or cardiac shunt.
* The patient will likely need an immediate heart transplant due to hemodynamic instability.
* The patient has had a known active malignancy or treatment for cancer within the past year except for localized prostate cancer, cervical carcinoma in situ, breast cancer in situ, or non-melanoma skin cancer that has been definitively treated.
* The patient has history of any malignancy where expected survival is less than two years. Past medical history of cancer is not exclusionary as long as subject has been disease-free for at least one years since the time of diagnosis and treatment.
* Patient has a severe co-morbidity (current need for hemodialysis or current glomerular filtration rate(GFR) ≤20 mL/minute/1.73 m2 estimated by Modification of Diet in Renal Disease( MDRD)calculation; hepatic impairment defined as liver function tests \[alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP)\] \>3x Upper Limit of Normal within 30 days prior to LVAD implantation or known objectively confirmed intrinsic liver disease (e.g., cirrhosis, chronic hepatitis B or hepatitis C virus infection)).
* The patient has a known bleeding diathesis or thrombocytopenia defined as platelet count \<50,000 platelets/μL.
* The patient has peri/postpartum cardiomyopathy, or is a pregnant or lactating woman, or a woman of child-bearing age not using a suitable method of contraception.
* The patient, who in the absence of an Implantable Cardioverter Defibrillator (ICD) (or any implanted device capable of defibrillation), has a history of malignant ventricular arrhythmia or sustained ventricular tachycardia (VT), with sustained VT demonstrated by Q wave R wave S wave (QRS) complexes wider than 120 milliseconds, lasting more than 30 seconds, and with a rate of more than 100 beats per minute on screening ECG or other data supporting this diagnosis.
* Recent history of psychiatric disease, including drug or alcohol abuse, that is likely to impair, in the opinion of the investigator, the subject's ability to comply with protocol-mandated procedures.
* Participation in any other clinical investigation that is likely to confound study results or affect study outcome

Primary outcomes:
measure: Number of Participants With the Composite Outcome of Moderate or Severe Right Ventricular (RV) Dysfunction (Perioperative Right Heart Failure), Severe Renal Dysfunction Requiring Renal Replacement Therapy, Thrombotic Complications, or Death From Any Cause
timeFrame: from time of implantation to 30 days post-implantation
Secondary outcomes:
measure: Number of Participants With a Need for Blood Product Transfusion Within 48-hours Post-implantation
timeFrame: from time of implantation to 48 hours post-implantation
measure: Operative Safety as Indicated by the Number of Participants Who Died Within 30 Days Post-implantation
timeFrame: from time of implantation to 30 days post-implantation
measure: Operative Safety as Indicated by Chest Tube Output Within 24 Hours of Implantation
timeFrame: from time of implantation to 24 hours post-implantation
measure: Operative Safety as Indicated by Number of Participants Who Underwent Post-operative Re-exploration for Bleeding
timeFrame: from time of implantation to 30 days post-implantation
measure: Number of Participants With Allosensitization
timeFrame: 30 days post-implantation
measure: Number of Participants With Allosensitization
timeFrame: 6 months post-implantation
measure: Number of Participants With Allosensitization
timeFrame: 12 months post-implantation
measure: Number of Readmissions for Heart Failure
timeFrame: from time of implantation to 1 year post-implantation
measure: Overall Hemostatic Potential
timeFrame: Baseline
measure: Overall Coagulation Potential
timeFrame: Baseline
measure: Overall Fibrinolytic Potential
timeFrame: Baseline
measure: Overall Hemostatic Potential
timeFrame: 48 hours post-implantation
measure: Overall Coagulation Potential
timeFrame: 48 hours post-implantation
measure: Overall Fibrinolytic Potential
timeFrame: 48 hours post-implantation
measure: Number of Participants With Major Bleeding
timeFrame: 30 days post-implantation
measure: Number of Participants With Major Bleeding
timeFrame: 6 months post-implantation
measure: Number of Participants With Major Bleeding
timeFrame: 12 months post-implantation
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Igor D Gregoric, MD
role: PRINCIPAL_INVESTIGATOR
References: