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
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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=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=1,600 Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation
Atrial Fibrillation
Primary: Primary Effectiveness Endpoint: Stroke, All Cause Death, and Systemic Embolism — 44; 41 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 3 N=800 WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation
Atrial Fibrillation · Stroke
Primary: Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death — 2.2; 3.7 events per 100 pt yrs
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=100 Study of Intra-Cardiac Echocardiography in Guiding Left Atrial Appendage Occlusion With the Watchman Device
Left Atrial Appendage Occlusion
Primary: Successful Implantation of WATCHMAN FLX Device — 96 Participants
N/A N=458 Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology
Atrial Fibrillation
Primary: Number of Participants With a Safety Event — 2; 0 Participants
Phase 4 N=100 Efficacy of Short Term Dabigatran Etexilate Followed by Aspirin Monotherapy After LAA (Left Atrial Appendage) Device Closure (the DEA-LAA Study).
Atrial Fibrillation · Device Related Thrombus · Left Atrial Appendage Thrombosis
Primary: Device Related Thrombus (DRT) at 90 Days — 1 Participants
N/A N=156 VCLIP Post-Market Study, Long-term Follow-up on LAA Exclusion Using AtriClip
Left Atrial Appendage Absent
Primary: Primary Performance Endpoint — 151 Participants
N/A N=576 Continued Access to PREVAIL (CAP2) - WATCHMAN Left Atrial Appendage (LAA) Closure Technology
Atrial Fibrillation
Primary: Number of Participants With Ischemic Stroke — 47 Participants
Phase 2 N=13 Stroke Feasibility Study
Atrial Fibrillation · AFib
Primary: Number of Serious Adverse Events Within 30 Days Post-Index Procedure — 0 participants
N/A N=349 WATCH-TAVR, WATCHMAN for Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement
Atrial Fibrillation · Aortic Valve Stenosis
Primary: Composite of All-cause Mortality, Stroke and Bleeding — 60; 64 Participants
N/A N=20 The Conformal Prague Study
Non-valvular Atrial Fibrillation
Primary: Freedom From Major Adverse Events — 19 Participants
N/A N=500 HEAL-LAA Clinical Trial
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
N/A N=102 Left Atrial Imaging Prior to Cardioversion: Leveraging Computed Tomography to Rule Out Thrombus
Atrial Fibrillation
Primary: Time to Imaging — 28.1; 7.1 hours
N/A N=3,160 Exclusion of Intra-atrial Thrombus Before Catheter Ablation
Atrial Fibrillation · Thrombi
Primary: Number of Patients With Atrial Thrombus and a Zero ATE Score — 2; 816; 27; 2227 Participants
Phase 3 N=407 Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy
Atrial Fibrillation · Stroke
Primary: Primary Safety Endpoint (Device Group Only) — 6 Participants
N/A N=43 Watchman FLX Pro CT Pilot Study
Non-valvular Atrial Fibrillation (AF)
Primary: Number of Participants With Any Hypoattenuated Thickening (HAT) on the Surface of the Device — 3; 5; 5 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=54 A Study to Evaluate the Safety and Effectiveness of the Left Atrial Appendage Closure Therapy Using BSJ003W
Atrial Fibrillation Non-Rheumatic
Primary: Number of Participants With Complications; One of the Following Events — 0; 0 Participants
N/A N=35 The Evaluation of Thrombogenicity in Patients Undergoing WATCHMAN Left Atrial Appendage Closure Trial
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…
N/A N=50 Observe the Safety and Effectiveness of the WATCHMAN FLX™ for Subjects in Hong Kong
Non-valvular Atrial Fibrillation
Primary: Primary Effectiveness Endpoint — 0 percentage of occurence
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
Phase 3 N=27 Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus
Left Ventricular Thrombosis
Primary: Percent Change in Left Ventricular Thrombus (LVT) Size — -61.45; -65.08 percentage of change
Phase 2 N=30 Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices
Heart Failure
Primary: Freedom From Death or Hemocompatibility Related Adverse Events (Stroke, Device Thrombosis, Bleeding, Aortic Root Thrombus, and Arterial Non-CNS Thromboembolism) — 16; 12…
Phase 4 N=100 Efficacy of Optison Echo Contrast to Detect Thrombus in Left Atrial Appendage
Atrial Fibrillation
Primary: Percent Confidence in Assessment of Left Atrial Appendage Thrombus — 55; 95 Percentage of Confidence — p=< 0.001
N/A N=1,020 Registry on WATCHMAN Outcomes in Real-Life Utilization
Patients With Atrial Fibrillation at Risk for Thrombus Formation, Thromboembolism, Stroke
Primary: Procedural Complications — 2.8 percentage of participants
N/A N=2,506 D-dimer Assay for the Exclusion of Intra-atrial Thrombus Risk Before Ablation of Atrial Fibrillation
Atrial Fibrillation
Primary: Number of Patients With Atrial Thrombus Diagnosed by Transoesophageal Ultrasound — 48 Participants