Clinical Trial Search

Primary: Percentage of Participants With Freedom From Primary Safety Events at 12 Months Post-procedure (Acute and Chronic Events) Using the Boston Scientific Cardiac…

Primary: Number of Participants With Recurrence of Atrial Tachyarrhythmia — 36; 44 Participants — p=0.0016

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

Primary: Chronic Effectiveness — 56; 26 percentage of participants with success — p=<0.0001

Primary: The Incidence of Early Onset Primary Adverse Events — 5.5 percentage of participants

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…

Primary: Number of Participants With Any Primary Adverse Events (PAE) That Occurred Within 7 Days Following Atrial Fibrillation (AF) Ablation Procedure Using HELIOSTAR Catheter…

Primary: Number of Participants With Primary Adverse Events (PAEs) — 0; 0; 0 Participants

Primary: Primary Safety Endpoint (PSE): Event Rate of Safety Events Post Procedure — 2.3; 2.4 Percentage of participants

Primary: Percentage of Participants With Treatment Success at 12 Months After Antiarrhythmic Drug (AAD) Initiation or Ablation Utilizing the Arctic Front Advance™ Cardiac…

Primary: The Rate of Subjects Who Were Free From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 12-month…

Primary: Subjects Achieving Normal Sinus Rhythm (NSR) in Patients With Paroxysmal AF — 0; 2; 0; 0 Participants

Primary: The Percentage of Chronic Success of the NAVISTAR THERMOCOOL Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (PAF) — 66; 16 Percentage of…

Primary: Occurence of Device-or Procedure-related Early and Late-onset of Serious Adverse Events — 0 Participants

Primary: Mean Percentage of Time Spent in Atrial Fibrillation — 2.74; 5.85 percentage of time

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…

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…

Primary: Safety at 30 Days — 1 Participants

Primary: Confirmation of Entrance Block in the Pulmonary Veins — 159; 157 participants

Primary: Acute Procedural Success (APS) — 160 participants

Primary: Proportion of Subjects Who Were Free From Atrial Arrhythmia at One Year. — 10; 18; 29; 20 participants — p=0.048

Primary: Composite Safety Endpoint;Proportion of MITT Subjects With One or More of the Specified Device or Procedure Related SAEs — 6; 4 Participants

Primary: Freedom From Atrial Fibrillation Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Recurrence at 12 Months Post Procedure. — 72; 76 Participants

Primary: Percent of Subjects With a Primary Adverse Event — 3; 2 Participants — p=<0.0001

Primary: Percentage of Participants With Primary Adverse Events (PAEs) — 0.0; 0.0; 1.5; 1.5 percentage of participants

Primary: Atrial Tachyarrhythmia Recurrence in Participants — 37 participants

Primary: Time to First Atrial Fibrillation (AF) Recurrence or Atrial Flutter Emergence Defined by the Time to First Episode of AF or Atrial Flutter Lasting for at Least 10…

Primary: Change in AF Burden — 5.6; 5.0; 4.1; 4.3 percentage of time in AF — p=0.520

Primary: Primary Safety Endpoint — 0; 0; 4.2; 0 percentage of participants

Primary: Safety: Number of Participants With at Least One Primary Safety Event — 1; 1 Participants