30 closest matches · ranked by relevance
Foramen Ovale, Patent · Heart Catheterization · Heart Septal Defects, Atrial
Primary: Number of Participants With a Successful Implantation. — 62 participants
Cryptogenic Stroke
Primary: Composite of Recurrent Nonfatal Ischemic Stroke, Fatal Ischemic Stroke, or Early Death After Randomization — 9; 16 Participants — p=0.08
Platelet Aggregation, Spontaneous · Migraine With Aura · Patent Foramen Ovale
Primary: Change in Migraine Characteristics — 43; 2; 17 Participants
Stroke · Transient Ischemic Attack
Primary: Number of Subjects With Freedom From Recurrent Ischemic Stroke (Primary Outcome #1) — 6; 12 Participants — p=0.001
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…
Patent Ductus Arteriosus (PDA)
Primary: Reporting of Late Adverse Events Relating to the Device. — 9 participant
Atrial Septal Defect
Primary: Percent of Subjects With Two-year Device-related Hemodynamic Compromise — 0.65 percentage of participants
Patent Foramen Ovale
Primary: Arterial Nitrogen Bubbles After Surfacing — 0; 6; 0; 7 participants — p=0.02
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
Migraine With Aura · Patent Foramen Ovale
Primary: Embolic Tracks
Atrial Septal Defect
Primary: Number of Subjects With 6-Month Closure Success — 112 Participants — p=<0.0001
Atrial Fibrillation
Primary: Number of Participants With Ischemic Stroke — 47 Participants
Ventricular Septal Defects
Primary: Primary Effectiveness End Point: Technical Success — 75 Participants
Post-Infarction Ventricular Septal Defect
Primary: Effectiveness Endpoint 1: Technical Success — 76 Participants
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…
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
Septal Defect, Atrial
Primary: Number of Subjects With 6-Month Composite Clinical Success — 332 Participants — p=<0.0001
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…
Septal Defect, Atrial
Primary: Efficacy — 180; 171; 9; 8 Participants
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
Aortic Valve Stenosis
Primary: Number of Participants With Major Vascular Complications — 2; 1 Participants
Single-ventricle
Primary: Change in Pulmonary Pulsatility Index — 51.6; 57.6 Ratio — p=0.1
Heart Septal Defects, Ventricular
Primary: Closure of Muscular Ventricular Septal Defects — 91 participants
Patent Ductus Arteriosus
Primary: False Positives Results of Pocket Echocardiography System (PES) Detection of Patent Ductus Arteriosus (PDA) to Full Featured Echo System (FFES) — 10.8 percentage of…
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
PFO - Patent Foramen Ovale · ASD - Atrial Septal Defect · VSD - Muscular Ventricular Septal Defect
Primary: Effectiveness Endpoint: Rate of Technical Success — 247; 3 Participants — p=0.0044
Hernia · Hernia, Diaphragmatic · Hernia, DIaphragmatic, Congenital
Primary: Proportion of Neonate Survival at Discharge From Hospital — 1; 3 Participants
Heart Defects, Congenital
Primary: The Number of Graft Related Post-operative Complications That Require a Repeat Surgery or a Non Surgical Treatment Within 12-month Post Implantation. — 0 Participants
Coronary Artery Disease · Aortic Valve Disorder · Heart Failure
Primary: Subject's Percentage of Long Term Safety Performance — 1.5; 2.7; 0.2; 0.4 Percentage of events/late patient years
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…