N/A N=1,000 Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study
Atrial Septal Defect
Primary: Percent of Subjects With Two-year Device-related Hemodynamic Compromise — 0.65 percentage of participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=125 Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs
Atrial Septal Defect
Primary: Number of Subjects With 6-Month Closure Success — 112 Participants — p=<0.0001
N/A N=400 Safety and Efficacy of the GORE® Septal Occluder to Treat Ostium Secundum Atrial Septal Defects
Septal Defect, Atrial
Primary: Number of Subjects With 6-Month Composite Clinical Success — 332 Participants — p=<0.0001
N/A N=215 Long-term Safety Study of the GORE® HELEX® Septal Occluder
Septal Defect, Atrial
Primary: Efficacy — 180; 171; 9; 8 Participants
N/A N=192 AMPLATZER Duct Occluder II Clinical Study
Patent Ductus Arteriosus
Primary: The Primary Safety Endpoint is the Rate of Device and Procedure Related Serious Adverse Events (SAE) 180 Days Post Procedure. — 1.6 percentage of participants
N/A N=165 Safety and Efficacy Study of Absnow Absorbable ASD Closure System For Treating ASD Patients
Heart Septal Defects, Atrial · Atrial Septal Defect
Primary: Effective Closure Rate at 360-day Post Operation — 158 Participants
N/A N=91 Closure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder
Heart Septal Defects, Ventricular
Primary: Closure of Muscular Ventricular Septal Defects — 91 participants
N/A N=92 Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study
Ventricular Septal Defects
Primary: Primary Effectiveness End Point: Technical Success — 75 Participants
N/A N=215 Septal - Success Rate and Clinical Outcome of Septal Implant of Ventricular Defibrillation Lead
Ventricular Tachycardia · Ventricular Fibrillation
Primary: Implant Success Rate at Septal Site — 97; 99 Participants
N/A N=436 Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder
Patent Ductus Arteriosus (PDA)
Primary: Reporting of Late Adverse Events Relating to the Device. — 9 participant
N/A N=200 AMPLATZER Duct Occluder II Additional Sizes
Patent Ductus Arteriosus
Primary: Safety Endpoint: The Rate of Major Complications After an Attempted ADO II AS Device Implant — 0; 2.8 percentage of participants
N/A N=63 Procedural Success and Safety of the Nit-Occlud® Patent Foramen Ovale (PFO) Closure Device and Its Application System
Foramen Ovale, Patent · Heart Catheterization · Heart Septal Defects, Atrial
Primary: Number of Participants With a Successful Implantation. — 62 participants
N/A N=97 AMPLATZER Cardiac Plug Clinical Trial
Atrial Fibrillation · Ischemic Stroke · Peripheral Thromboembolism
Primary: Acute Safety - Procedure Related SAEs From Randomization Through Discharge For Device Arm Only — 3; 1; 1; 3 events
N/A N=664 GORE® Septal Occluder Device for Patent Foramen Ovale (PFO) Closure in Stroke Patients
Stroke · Transient Ischemic Attack
Primary: Number of Subjects With Freedom From Recurrent Ischemic Stroke (Primary Outcome #1) — 6; 12 Participants — p=0.001
N/A N=520 AMPLATZER™ LAA Occluder Post Approval Study (PAS)
Atrial Fibrillation · Thromboembolism · Stroke
Primary: Primary Effectiveness Endpoint 1: Composite Rate of Stroke (Including Ischemic or Hemorrhagic), Systemic Embolism and Cardiovascular or Unexplained Death — 14.28…
N/A N=980 Patent Foramen Ovale Closure or Medical Therapy After Stroke - RESPECT Trial
Cryptogenic Stroke
Primary: Composite of Recurrent Nonfatal Ischemic Stroke, Fatal Ischemic Stroke, or Early Death After Randomization — 9; 16 Participants — p=0.08
N/A N=131 The AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) Post Approval Study
Post-Infarction Ventricular Septal Defect
Primary: Effectiveness Endpoint 1: Technical Success — 76 Participants
N/A N=16 AF Septal Pacing (Clinical Investigation Plan)
Paroxysmal Atrial Fibrillation · Persistent Atrial Fibrillation
Primary: Number of Electrodes in a Stable Position — 38 Electrode pairs
Phase 4 N=562 AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)
Post-Operative Atrial Fibrillation
Primary: Number of Perioperative Complications Associated With AtriClip Placement — 0 perioperative complications reported
N/A N=35 Prospective Elimination Of Distal Coronary Sinus-Left Atrial Connections for Atrial Fibrillation Ablation Trial
Atrial Fibrillation · Arrhythmias, Cardiac
Primary: Recurrence Rate of Atrial Arrhythmias — 8; 14; 7; 1 participants — p=0.047
N/A N=9 Left Atrial Appendage Closure With SentreHeart Lariat® Device
Cardioembolic Stroke · Atrial Fibrillation
Primary: Number of Participants With Successful Stand-Alone Left Atrial Appendage Closure Using SentreHeart Lariat Device as Measured by Left Atrial Appendage Closure Rates — 6…
Phase 4 N=396 TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients
Heart Failure, Congestive
Primary: Unplanned Hospital Admissions for Cardiac Reasons OR Death of Cardiovascular Causes OR Progression to Chronic Atrial Fibrillation — 43; 44 participants
N/A N=230 PREMIUM Migraine Trial
Migraine Headaches · Patent Foramen Ovale
Primary: Primary Efficacy Endpoint - Percentage of Subjects With a 50% Reduction From Baseline in the Monthly Number of Migraine Attacks at 12 Months. — 32; 38 percentage of…
N/A N=43 ACC - Atrial Contribution to CRT
Dilated Cardiomyopathy
Primary: Aortic Velocity Time Integral (VTI) — 22.4; 21.7; 19.4; 18.1 cm
Phase 2 N=29 Safety and Effectiveness of the Device "Nit-Occlud® PDA-R"
Congenital Heart Disease
Primary: Number of Patients With a Closed Patent Ductus Arteriosus (Defect) Determinated by Echocardiography ( Time Frame: One Year After Treatment) — 19; 23; 28; 29 Participants…
N/A N=154 RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt
Embolic Stroke of Undetermined Source · Transient Ischemic Attack · Right-To-Left Atrial Shunt
Primary: Percent Detection of Right to Left Shunt (RLS)/Patent Foramen Ovale (PFO) Using Robotic Assisted TCD (Study Device) — 74; 47; 24; 97 Participants — p=<0.001
N/A N=24 Dual Epicardial Endocardial Persistent Atrial Fibrillation (AF) Study
Persistent Atrial Fibrillation · Longstanding Persistent Atrial Fibrillation
Primary: Primary Safety Endpoint — 0; 0; 4.2; 0 percentage of participants
N/A N=1,878 AMPLATZER™ Amulet™ LAA Occluder Trial
Stroke
Primary: Primary Safety Endpoint: Composite Endpoint Rate of Procedure-related Complications, or All-cause Death or Major Bleeding (Defined as Type 3 or Greater Based on the…
Phase 2 N=60 Safety Study of Varisolve® Procedure for Treatment of Varicose Veins in Patients With Right-to-left Cardiac Shunt
Varicose Veins
Primary: Patients With Circulating MCA Bubbles Present on MRI Who Had Signficant Clinical or Neurological Effects — 0 participants
N/A N=138 ALternate Site Cardiac ReSYNChronization (ALSYNC) Study
Heart Failure
Primary: Percentage of Patients Free From Lead, Delivery System and Implant Related Complications. — 82.2 percentage of patients