N/A N=25 A Silver Lining in the VAD Sky
LVAD (Left Ventricular Assist Device) Driveline Infection
Primary: Driveline Infection Rate — 0.51; 06.28 infections per 100 patient-month
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=190 Attain Model 4196 Left Ventricular (LV) Lead
Heart Failure
Primary: Safety (Subjects Without a Model 4196 Lead Related Complication) — 168 participants
N/A N=200 Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Destination Therapy
Heart Failure, Congestive · Ventricular Dysfunction · Cardiomyopathies
Primary: Composite Endpoint — 46; 11 percentage of participants — p=0.00000025
N/A N=10 Monitoring Medication Adherence in Left Ventricular Assist Device Recipients
Heart Failure · Medication Compliance
Primary: System Performance - Positive Detection Accuracy — 80 percentage of ingestions
N/A N=211 Identifying and Facilitating Ventricular Recovery on Mechanical Support
Heart Failure
Primary: Number of Subjects With Left Ventricular Recovery and LVAD Explant — 8 Participants
Phase 4 N=434 Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage (EVD) System
Intraventricular Hemorrhage · Subarachnoid Hemorrhage
Primary: Number of Infections — 4; 5; 4; 5 Infections
N/A N=1,615 TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD
Cardiac Implantable Electronic Device Infection
Primary: Major CIED Infection — 0.6; 1.0; 0.7 percentage of Participants — p=0.0023
N/A N=83 Repair of Infected or Contaminated Hernias
Hernia
Primary: Incidence of Wound Events — 53 participants
N/A N=197 Model 4396 Left Ventricular (LV) Lead Study
Heart Failure
Primary: Safety (Subjects Without a Model 4396 Lead Related Complication) — 155 participants
N/A N=194 Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Bridge to Cardiac Transplantation
Heart Failure, Congestive · Ventricular Dysfunction · Cardiomyopathies
Primary: Survival — 112; 6; 18; 19 participants
Phase 2 N=10 Interleukin-1 Receptor Antagonist for the Treatment of Heart Failure in Patients With Left Ventricular Assist Devices
Heart Failure
Primary: Biologic Efficacy: Inflammation Marker - C-Reactive Protein — 2.5; 0.6; 0.6 mg/dL
Phase 3 N=1,010 Perioperative Antibiotic Therapy to Prevent Cardiac Implantable Electronic Device Infections.
Sick Sinus Syndrome · Complete Heart Block · Syncope
Primary: Number of Patients With a Major Cardiac Implantable Electronic Devices (CIED) Infection — 5; 6 Participants
Phase 4 N=13 Antifungal Locks to Treat Fungal-related Central Line Infections
Central Line Fungal Infections
Primary: Number of Patients With 2 Negative Fungal Cultures After 5 Days of Combined Systemic Antifungal and Antifungal Lock Therapy and the CVC Was Not Removed — 10; 3…
N/A N=90 Model 4296 Left Ventricular (LV) Lead Study
Heart Failure
Primary: Number of Participants With Left Ventricular (LV)Lead Related Complications — 1 participants
Phase 4 N=6,983 World-wide Randomized Antibiotic Envelope Infection Prevention Trial
CIED Related Infection
Primary: 12 Month Kaplan-Meier Estimate of Major CIED Infection Rate — 0.7; 1.2 Percentage of subjects — p=0.0406
Phase 2 N=25 Stem Cell Therapy in Patients With Severe Heart Failure & Undergoing Left Ventricular Assist Device Placement
Heart Failure
Primary: Safety of Cell Delivery — 1; 0 adverse events
Phase 2 N=104 Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction
Nonmalignant Breast Conditions · Breast Cancer
Primary: Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Approximately 1 Week — 10; 21 participants — p=0.02
N/A N=639 Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure
Chronic Heart Failure
Primary: The Primary Endpoint is Success at 180 Days Which is Defined as Alive on the Originally Implanted HeartWare® LVAD or Transplanted or Explanted for Recovery. Patient Must…
N/A N=445 PCORI-1310-06998 Trial of a Decision Support Intervention for Patients and Caregivers Offered Destination Therapy Heart Assist Device
Heart Failure · Heart-assist Devices
Primary: Reach of Intervention — 107; 64 Participants
Phase 3 N=120 Vdrive Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study
Atrial Fibrillation
Primary: The Primary Effectiveness Endpoint is the Successful Navigation and EGM Recording of Each Pre-specified Pulmonary Vein Per Procedure Between Both the Control and the…
N/A N=32 Microcurrent Dressing to Treat Infections, Before, During and After Surgery
Shoulder Arthropathy Associated With Other Conditions · Shoulder Arthritis · Shoulder Osteoarthritis
Primary: Measurement of Change in Cutibacterium Acnes — 3; 8; 3; 2 Participants — p=0.004
Phase 2 N=15 Technology That Permits Focal Dose of Antibiotics to be Delivered to Lower Limb(s) of Diabetic Patients
Diabetes · Infection
Primary: Efficacy of Timentin Delivered by PILP Procedure (Treatment Group) Versus Intravenous Delivery (Control Group) at Reducing Microbiological Load in Subjects With…
N/A N=98 Development & Testing of a Decision Aid for LVAD Placement
End-Stage Heart Failure · Bridge-to-Transplant LVAD Placement (BTT) · Destination Therapy LVAD Placement (DT)
Primary: Left Ventricular Assist Device (LVAD) Knowledge Scale — 45.6; 43.8 units on a scale
N/A N=40 Self-Management App for Patients With Left-Ventricular Assist Devices
Heart Failure
Primary: Health-related Quality of Life — 49.8; 53.8; 72.7; 57.6 score on a scale — p=<0.05
N/A N=499 Quartet 1457Q Left Ventricular (LV) Lead Investigational Device Exemption (IDE) Study
Heart Failure
Primary: Number of Patients Free From LV Lead-related Complications Through 3 Months — 4 Participants — p=0.05
Phase 3 N=95 Ethanol Lock Therapy for Treatment and Secondary Prophylaxis of Central Line-Associated Bloodstream Infection
Central Line-Associated Bloodstream Infection
Primary: Percentage of Therapeutic Failures (Early or Late Failure) in Children and Adolescents With CLABSI Receiving Standard Care Plus Ethanol Lock Therapy (ELT) vs. Standard…
N/A N=103 Percutaneous Less Invasive AV Fistula for Vascular Access in ESRD
End Stage Renal Disease · AV Fistula · Fistula
Primary: Maturation Success Rate at 90 Days — 92 Participants
N/A N=105 DIVINE: Dialysis Infection and Vitamin D In New England
End Stage Renal Disease
Primary: Serum 25D Level — 49.8; 38.3; 27.3 ng/ml
N/A N=165 Passive Disinfection Cap Compliance Study
Infection, Hospital
Primary: Disinfecting Barrier Cap Compliance — 98.43 percentage of connector with compliance
N/A N=22 InterventiOn of Biventricular Pacemaker Function on ventrIcular Function Among Patients With LVAD's
Heart Diseases · Left Ventricular Dysfunction
Primary: Peak Vo2 — 33; 12.5 ml/kg/min