Clinical Trial Search

Primary: Percent of Patients Free From AF and Off Class I and III Anti-arrhythmic Drugs as Determined by Holter Monitoring at 6 Months. — 74 percentage of subjects

Primary: All Hospital Episodes (Emergency Room or Patient Request for OPD) Related to Treatment for Atrial Arrhythmia — 19; 76; 23 Participants — p=<0.0001

Primary: Survival Free of Atrial Fibrillation — 28; 31 participants

Primary: Number of Participants With Successful Pulmonary Vein Isolation — 53 participants

Primary: Change in Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)% — 2.8; 4.5 percentage of blood ejected in one beat

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

Primary: Number of Subjects That Achieved Freedom From AF/AFL/AT (Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia) With or Without the Use of Anti-arrhythmic Drugs After a…

Primary: Percentage of Patient With Atrial Fibrillation Termination at the End of the Procedure — 95; 60 Percentage of participants

Primary: Freedom From Atrial Fibrillation — 31.1; 61.8 percentage of patients

Primary: To Define the Normal Range of Voltage Amplitude — 2.00; 1.92 mV

Primary: Recurrence Rate of Atrial Arrhythmias — 8; 14; 7; 1 participants — p=0.047

Primary: Numbers of Participants Free From AF — 20; 96; 20; 97 Participants

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

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

Primary: Number of Participants Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up — 20; 14 participants

Primary: Number of Participants That Meeting the Efficacy Success Criteria as Described in the Outcome Measure Description — 102; 103 Successful 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: Freedom From Recurrence of Atrial Fibrillation — 50 successful participants

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

Primary: Safety of Ablation Using the AFreeze Cryoablation System Consisting of the CoolLoop® Ablation Catheter, Its Steerable Sheath and the Cryoconsole Cryo-Caddy Assessed by…

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

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

Primary: Number of Participants Free From Documented AF After One Ablation Procedure — 158; 124 Participants

Primary: Percentage of Participants With Primary Adverse Events (PAEs) — 0.0; 0.0; 1.5; 1.5 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: 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: 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: Composite Endpoint: Atrial Arrhythmias Lasting >24 Hrs or Requiring Antiarrhythmic Drug Therapy; Need for Cardioversion/Repeat Ablation During the Study Period; Adverse…

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

Primary: Composite of All-cause Mortality and Heart Failure Events — 50; 64 Participants