Clinical Trial Search

Primary: Incidence of Paroxysmal Atrial Fibrillation (AF) in Ischemic Stroke Patients — 6 Participants

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

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

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

Primary: Occurence of Device-or Procedure-related Early and Late-onset of Serious Adverse Events — 0 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 Device or Procedure-related Serious Adverse Events — 12; 2 Participants

Primary: Safety at 30 Days — 1 Participants

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

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

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

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

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

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

Primary: Number of Days on Anticoagulation — 24.9 days

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

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

Primary: Conversion From Atrial Fibrillation to Sinus Rhythm — 8; 5 participants

Primary: Number of Subjects Who Had Atrial Fibrillation Recurrence at 1 Year — 3; 3 participants

Primary: Number of Participants That Meeting the Efficacy Success Criteria as Described in the Outcome Measure Description — 102; 103 Successful Participants

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: 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: Pivotal Main Phase Modified Intent-To-Treat (mITT) Analysis Set: Number of Participants With Primary Adverse Events (PAEs) — 8 Participants

Primary: Safety: Number of Participants With Prespecified Primary Safety Events Within 30 Days of Index Procedure. — 0 Participants

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

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

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: Acute Procedural Success (APS) — 160 participants

Primary: Composite Safety Endpoint;Proportion of Intent to Treat Subjects With One or More of the Specified Device or Procedure Related SAEs — 0 participants

Primary: Percentage of Participants With Acute Success Post CartoFinder Guided Ablation (CFGA) Only (Before Pulmonary Vein Isolation [PVI] and Without Cardioversion). — 22.9…