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=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=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=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=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 Long-term Safety Study of the GORE® HELEX® Septal Occluder
Septal Defect, Atrial
Primary: Efficacy — 180; 171; 9; 8 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
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=72 Transseptal Needle Versus Radiofrequency Energy for Left Atrial Access
Heart Diseases
Primary: Transseptal Access Procedure Time — 2.3; 7.3 minutes — p=0.005
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=26 Dual Epicardial Endocardial Persistent Atrial Fibrillation(AF) Study (Staged DEEP)
Atrial Fibrillation
Primary: Number of Patients With Pre-specified Safety Endpoints Occurring in the First 30 Days Post-index Procedure or Hospital Discharge, Whichever is Longer. — 3 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=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=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=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=160 Multimodality Evaluation of LAA Leaks Arising After Incomplete LAAC: Insights From the LAA-Leak Registry
Left Atrail Appendage Closure: Peri-device Leaks
Primary: Size of PDL After Leak Closure Procedure — 0; 0; 0; 64 Participants
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
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=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=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=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=40 Effect of Structural Remodeling on Scar Formation as Assessed by DE-MRI of the Left Atrium
Atrial Fibrillation
Primary: Left Atrial (LA) Remodeling Pre-ablation — 2; 31; 7; 0 participants — p=0.48
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…
N/A N=50 Pulmonary Artery Repair With Covered Stents
Pulmonary Stenosis · Pulmonary Regurgitation · Tetralogy of Fallot
Primary: Successful Repair of Conduit Disruption — 48 participants
Phase 3 N=55 AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation
Atrial Fibrillation
Primary: Percent of Patients Free From AF and Off Class I and III Anti-arrhythmic Drugs as Determined by Holter Monitoring at 6 Months. — 74 percentage of subjects
Phase 2 N=70 AtriCure Exclusion of the LAA in Patients Undergoing Concomitant Cardiac Surgery
Left Atrial Appendage Exclusion
Primary: Rate of Device Related Serious Adverse Events — 0 Number of participants
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
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…