Phase 2 N=523 Long-term Safety in Atrial Fibrillation Patients
Persistent or Permanent Nonvalvular Atrial Fibrillation
Primary: Bleeding: Number of Patients With Any Bleeding Event, During Treatment Period — 55; 56 Participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=6,443 Post-Marketing Surveillance of Prazaxa® on the Long-term Use in Patients With Nonvalvular Atrial Fibrillation
Atrial Fibrillation
Primary: Frequency (Percentage) of Participants With Adverse Drug Reactions — 28.2 Percentage of participants
Phase 3 N=210 Tailored Treatment of Permanent Atrial Fibrillation
Atrial Fibrillation
Primary: Chronic Effectiveness — 56; 26 percentage of participants with success — p=<0.0001
N/A N=80 The FARAPULSE PersAFOne III Trial for the Treatment of Persistent Atrial Fibrillation
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…
Phase 4 N=59 Rhythm Evaluation for AntiCoagulaTion With COntinuous Monitoring
Atrial Fibrillation
Primary: Number of Days on Anticoagulation — 24.9 days
N/A N=148 PRescriptiOn PattERns Of Oral Anticoagulants
Atrial Fibrillation
Primary: Number of Patients With at Least One Inappropriate MAI Criterion — 61; 11; 17 participants
N/A N=28 Feasibility Study of the FARAPULSE Endocardial Multi Ablation System in the Treatment of Persistent Atrial Fibrillation
Persistent Atrial Fibrillation
Primary: Safety at 30 Days — 1 Participants
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
Phase 4 N=676 Uninterrupted Dabigatran Etexilate in Comparison to Uninterrupted Warfarin in Pulmonary Vein Ablation (RE-CIRCUIT)
Atrial Fibrillation
Primary: Incidence of Major Bleeding Events (MBEs), as Defined by the International Society on Thrombosis and Haemostasis (ISTH) — 1.6; 6.9 percentage of participants — p=0.0009
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=186 STOP Persistent AF
Atrial Fibrillation
Primary: Percent of Subjects Free From Treatment Failure at 12 Months After the Pulmonary Vein Isolation (PVI) Ablation Procedure. — 54.8 percentage of participants — p=<0.001
N/A N=365 ABLATE Post Approval Study - Synergy Ablation Lesions for Non-Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation · Longstanding Persistent Atrial Fibrillation
Primary: The Number of Participants Free From Atrial Fibrillation (AF), Atrial Flutter or Atrial Tachycardia While Off Class I and Class III Antiarrhythmic Drugs for at Least 4…
N/A N=272 A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE)
Atrial Fibrillation
Primary: Number of Participants With Primary Adverse Events (PAEs) — 0; 0; 0 Participants
N/A N=73,989 Safety and Effectiveness of Oral Anticoagulants in Patients With Non-valvular Atrial Fibrillation
Non-valvular Atrial Fibrillation
Primary: Event Rate Per 100 Participant-Years For First Occurrence of Stroke and Systemic Embolism Events After Index Date — 3.2; 1.67; 2.08; 1.79 Events Per 100…
N/A N=1,305 Patients' Assessment of Satisfaction for Stroke Prevention in Atrial Fibrillation
Atrial Fibrillation
Primary: Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment…
N/A N=53 Occult Paroxysmal Atrial Fibrillation in Non-Cryptogenic Ischemic Stroke
Ischemic Stroke
Primary: Incidence of Paroxysmal Atrial Fibrillation (AF) in Ischemic Stroke Patients — 6 Participants
N/A N=669 A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects With Persistent Atrial Fibrillation
Persistent Atrial Fibrillation
Primary: Primary Safety Endpoint (PSE): Event Rate of Safety Events Post Procedure — 2.3; 2.4 Percentage of participants
Phase 4 N=67 Heart Rate Regularization in Patients With Permanent Atrial Fibrillation Post Marketing Study
Permanent Atrial Fibrillation
Primary: Patients Mode Preference (VRS ON, VRS OFF, NO PREFERENCE) — 32; 32; 15; 15 participants — p=<0.0001
N/A N=110 Comparison of Pulmonary Vein Ablation With or Without Left Atrial Posterior Wall Ablation for Persistent AF (PIVoTAL)
Atrial Fibrillation Chronic · Persistent Atrial Fibrillation
Primary: 1-year Freedom From Recurrent Atrial Arrhythmias — 25; 14 Participants
N/A N=320 Cryoballoon PVI With PWI Versus PVI Alone In Patients With PAF
Paroxysmal Atrial Fibrillation
Primary: Number of Participants With Recurrent Atrial Fibrillation — 60; 31 Participants
Phase 4 N=441 Study of Continuous Cardiac Monitoring to Assess Atrial Fibrillation After Cryptogenic Stroke
Cryptogenic Symptomatic Transient Ischemic Attack · Cryptogenic Ischemic Stroke
Primary: AF Detection Rate Within 6 Months — 8.9; 1.4 percentage of participants — p=0.0006
Phase 4 N=300 Apixaban Evaluation of Interrupted Or Uninterrupted Anticoagulation for Ablation of Atrial Fibrillation
Atrial Fibrillation
Primary: Number of Patients With Clinically-Significant Bleeding — 14; 17 Participants
Phase 1 N=48 A Trial to Determine the Safety, Pharmacokinetics, and Efficacy of OPC-108459 Administered as a Single Intravenous Dose to Patients With Paroxysmal or Persistent Atrial Fibrillation (AF)
Atrial Fibrillation
Primary: Subjects Achieving Normal Sinus Rhythm (NSR) in Patients With Paroxysmal AF — 0; 2; 0; 0 Participants
N/A N=1,421 Drug Persistence/Adherence in Patients Treated With Dabigatran or VKA for Stroke Prevention in Non Valvular Atrial Fibrillation (SPAF)
Atrial Fibrillation
Primary: Percentage of Patients Treated With Anticoagulation Initially Started at the 12 Month — 89.5; 89.5 percentage of participants — p=0.8496
N/A N=55 Hybrid Ablation Plus Medical Therapy for Persistent Atrial Fibrillation
Persistent Atrial Fibrillation
Primary: Atrial Fibrillation (AF) Burden Defined as the Mean Amount of Time Spent in AF Over a Pre-specified Period of Time (Excluding Short AF Episodes of ≤30 Seconds) by the…
N/A N=492 Rate of Atrial Fibrillation Through 12 Months in Patients With Recent Ischemic Stroke of Presumed Known Origin
Stroke, Acute
Primary: The Rate of AF Through 12 Months in Subjects With a Recent Ischemic Stroke of Presumed Known Origin. — 12.5; 1.8 percentage of participants — p=<0.001
N/A N=421 Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF
Atrial Fibrillation
Primary: Safety: Number of Participants With at Least One Primary Safety Event — 1; 1 Participants
N/A N=20 Feasibility Study of the FARAPULSE™ Cardiac Ablation System Plus in the Treatment of Persistent Atrial Fibrillation(PersAFOne II)
Persistent Atrial Fibrillation
Primary: Composite Safety Endpoint;Proportion of Intent to Treat Subjects With One or More of the Specified Device or Procedure Related SAEs — 0 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
Phase 3 N=199 n-3 Polyunsaturated Fatty Acids (PUFAs) in the Prevention of Atrial Fibrillation
Atrial Fibrillation
Primary: Probability of Maintenance of Sinus Rhythm at One-year Follow up.(Number of Patients Who Maintained Sinus Rhythm) — 61; 34 partecipants — p=< 0.05