30 closest matches · ranked by relevance
Left Atrail Appendage Closure: Peri-device Leaks
Primary: Size of PDL After Leak Closure Procedure — 0; 0; 0; 64 Participants
Atrial Fibrillation
Primary: Primary Effectiveness Endpoint: Stroke, All Cause Death, and Systemic Embolism — 44; 41 Participants
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…
Atrial Fibrillation
Primary: Number of Participants With Ischemic Stroke — 47 Participants
Atrial Fibrillation · Device Related Thrombus · Left Atrial Appendage Thrombosis
Primary: Device Related Thrombus (DRT) at 90 Days — 1 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…
Post-Operative Atrial Fibrillation
Primary: Number of Perioperative Complications Associated With AtriClip Placement — 0 perioperative complications reported
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…
Atrial Fibrillation
Primary: Number of Participants With a Safety Event — 2; 0 Participants
Atrial Fibrillation · Stroke
Primary: Primary Safety Endpoint (Device Group Only) — 6 Participants
Atrial Fibrillation · Stroke
Primary: Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death — 2.2; 3.7 events per 100 pt yrs
Non-valvular Atrial Fibrillation (AF)
Primary: Number of Participants With Any Hypoattenuated Thickening (HAT) on the Surface of the Device — 3; 5; 5 Participants
Atrial Septal Defect
Primary: Percent of Subjects With Two-year Device-related Hemodynamic Compromise — 0.65 percentage of participants
Left Atrial Appendage Exclusion
Primary: Rate of Device Related Serious Adverse Events — 0 Number of participants
Atrial Fibrillation · Aortic Valve Stenosis
Primary: Composite of All-cause Mortality, Stroke and Bleeding — 60; 64 Participants
Non-valvular Atrial Fibrillation
Primary: Freedom From Major Adverse Events — 19 Participants
Left Atrial Appendage Absent
Primary: Primary Performance Endpoint — 151 Participants
Atrial Fibrillation
Primary: Time to Hemostasis — 4.5; 10.7 seconds
Left Atrial Appendage Closure · WATCHMAN Device Implantation
Primary: Comparison of Thrombin Induced Platelet-fibrin Clot Strength (TIP-FCS) Between Patients With and Without Device Related Thrombosis (DRT) Assessed at 1-year of Watchman…
Left Atrial Appendage Occlusion
Primary: Successful Implantation of WATCHMAN FLX Device — 96 Participants
Arterial Occlusion · Cardiovascular Diseases · Hematoma
Primary: Time to Hemostasis — 5.11; 4.3 minutes
Atrial Fibrillation · Bleeding · Stroke
Primary: Primary Efficacy Endpoint: The Rate of Device Leak >5 mm at 45-day Post-Implant TEE for the Primary Analysis Subjects — 0 Participants
Patients With Atrial Fibrillation at Risk for Thrombus Formation, Thromboembolism, Stroke
Primary: Procedural Complications — 2.8 percentage of 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
Atrial Fibrillation · AFib
Primary: Number of Serious Adverse Events Within 30 Days Post-Index Procedure — 0 participants
Stroke · Transient Ischemic Attack
Primary: Number of Subjects With Freedom From Recurrent Ischemic Stroke (Primary Outcome #1) — 6; 12 Participants — p=0.001
Atrial Fibrillation · Thromboembolism · Stroke
Primary: Number of Participants With Acute Serious Adverse Events — 83 Participants
Foramen Ovale, Patent · Heart Catheterization · Heart Septal Defects, Atrial
Primary: Number of Participants With a Successful Implantation. — 62 participants
Atrial Fibrillation · Atrial Flutter · Heart Block
Primary: Time to Achieve Hemostasis — 7; 11 Minutes
Non-valvular Atrial Fibrillation (NVAF)
Primary: Short-Term Safety Endpoint: Composite Rate of Death, Stroke, Systemic Embolism, and Procedure or Device-related Complications Requiring Intervention — 1.1 percentage of…