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 Foramen Ovale
Primary: Arterial Nitrogen Bubbles After Surfacing — 0; 6; 0; 7 participants — p=0.02
Migraine With Aura · Patent Foramen Ovale
Primary: Embolic Tracks
Atrial Septal Defect
Primary: Percent of Subjects With Two-year Device-related Hemodynamic Compromise — 0.65 percentage of participants
Patent Ductus Arteriosus (PDA)
Primary: Reporting of Late Adverse Events Relating to the Device. — 9 participant
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
Atrial Septal Defect
Primary: Number of Subjects With 6-Month Closure Success — 112 Participants — p=<0.0001
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…
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
Septal Defect, Atrial
Primary: Number of Subjects With 6-Month Composite Clinical Success — 332 Participants — p=<0.0001
Ventricular Septal Defects
Primary: Primary Effectiveness End Point: Technical Success — 75 Participants
Ischemic Stroke
Primary: Incidence of Paroxysmal Atrial Fibrillation (AF) in Ischemic Stroke Patients — 6 Participants
Persistent Atrial Fibrillation
Primary: Primary Safety Endpoint: Composite Safety Endpoint (CSE) Defined as the Incidence of the Following Early-onset and Late-onset Serious Adverse Events (SAEs) Which Are…
Post-Infarction Ventricular Septal Defect
Primary: Effectiveness Endpoint 1: Technical Success — 76 Participants
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…
Paroxysmal Atrial Fibrillation
Primary: Composite Safety Endpoint;Proportion of MITT Subjects With One or More of the Specified Device or Procedure Related SAEs — 6; 4 Participants
Atrial Fibrillation
Primary: Safety: Number of Participants With at Least One Primary Safety Event — 1; 1 Participants
Persistent Atrial Fibrillation
Primary: Safety at 30 Days — 1 Participants
Atrial Fibrillation
Primary: Number of Participants With Ischemic Stroke — 47 Participants
Percutaneous CFA Arteriotomy Closure
Primary: Major Vascular Complications [Safety] — 0 Participants — p=<.0001
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
Paroxysmal Atrial Fibrillation
Primary: Number of Participants With Successful Pulmonary Vein Isolation — 53 participants
Atrial Fibrillation
Primary: Number of Participants With a Safety Event — 2; 0 Participants
Septal Defect, Atrial
Primary: Efficacy — 180; 171; 9; 8 Participants
Heart Septal Defects, Ventricular
Primary: Closure of Muscular Ventricular Septal Defects — 91 participants
Single-ventricle
Primary: Change in Pulmonary Pulsatility Index — 51.6; 57.6 Ratio — p=0.1