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
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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=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
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=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…
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=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=60 Repetitive Activation Patterns and Focal Impulses Identification and Ablation in Persistent AF
Persistent Atrial Fibrillation
Primary: Percentage of Participants With Acute Success Post CartoFinder Guided Ablation (CFGA) Only (Before Pulmonary Vein Isolation [PVI] and Without Cardioversion). — 22.9…
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=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
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=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
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=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
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=374 Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation
Atrial Fibrillation
Primary: Number of Participants Free From Documented AF After One Ablation Procedure — 158; 124 Participants
Phase 4 N=102 Electrophysiologically Guided PAcing Site Selection Study
Sinus Arrhythmia · Atrial Fibrillation
Primary: Number of Patients With Persistent Atrial Fibrillation (AF) After a Mean Follow-up of 15±7 Months: Comparison Between IAS and RAA Pacing in the Study Group — 2; 2; 9; 2…
N/A N=25 Atrial Fibrillation Recurrence in Sleep Apnea
Sleep Apnea · Atrial Fibrillation
Primary: Number of Subjects Who Had Atrial Fibrillation Recurrence at 1 Year — 3; 3 participants
N/A N=15 A Single Arm Pilot Study of Pulsed Field Ablation in the Treatment of Paroxysmal Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Primary: Occurence of Device-or Procedure-related Early and Late-onset of Serious Adverse Events — 0 Participants
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=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
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
N/A N=31 Characterising the Stable and Dynamic Left Atrial Substrate in Atrial Fibrillation
Atrial Fibrillation
Primary: To Define the Normal Range of Voltage Amplitude — 2.00; 1.92 mV
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
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
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
N/A N=109 Effect of Treatment of Sleep Apnea in Patients With Paroxysmal Atrial Fibrillation
Sleep Disordered Breathing · Sleep Apnea · Paroxysmal Atrial Fibrillation
Primary: Change in AF Burden — 5.6; 5.0; 4.1; 4.3 percentage of time in AF — p=0.520
N/A N=420 Treatment of Persistent Atrial Fibrillation With Sphere-9 Catheter and Affera Mapping and Ablation System
Atrial Fibrillation
Primary: Percent of Subjects With a Primary Adverse Event — 3; 2 Participants — p=<0.0001
N/A N=90 Pivotal Study Of A Dual Epicardial & Endocardial Procedure (DEEP) Approach
Atrial Fibrillation · Persistent or Longstanding Persistent Atrial Fibrillation
Primary: Primary Effectiveness Endpoint — 61 Participants
Phase 4 N=83 Selective Complex Fractionated Atrial Electrograms (CFAE) Targeting for Atrial Fibrillation
Atrial Fibrillation
Primary: Proportion of Subjects Who Were Free From Atrial Arrhythmia at One Year. — 10; 18; 29; 20 participants — p=0.048