Atrial Flutter Ablation With Contact Therapy Cool Path Ablation System Along With EnSite Velocity Contact System — CONTACT_AFL  

Typical Atrial Flutter Clinical Trial

Official title: Clinical Evaluation of Contact™ Therapy™ Cool Path™ Cardiac Ablation System in Conjunction With EnSite Velocity Contact™ Technology for the Treatment of Typical Atrial Flutter

Status Completed

Clinical Trial Summary

To demonstrate that the use of Contact Therapy™ Cool Path™ ablation catheter in conjunction with the EnSite Velocity Contact Technology for the treatment of typical atrial flutter

• Does not result into unacceptable risk of intra-procedural composite serious adverse events and,

• Does not affect efficacy of the ablation procedure The study will also evaluate the

Clinical Trial Description

This will be a prospective, multi-center and non-randomized study. All enrolled patients who meet the eligibility criteria will receive ablation therapy for typical atrial flutter using the Contact Therapy™ Cool Path™ Cardiac Ablation System. Historical data from published (PMA P060019 Cool Path) , reported (IDE G090109 Cool Path Duo) and published literature on Atrial Flutter RF ablation studies is used to determine performance goals for primary study endpoints and derive the sample size. In addition, the following analyses will be performed in the study

1. Validation of ECI against conventional methods of assessing tip tissue contact and

2. Ancillary analysis to assess the relationship between the ECI and study outcomes. Subjects will undergo two follow up visits at day 10 and month 3 post procedure. The following assessments will be performed during these visits:

• ECG

• Query regarding adverse events since the last visit

• Assessment of anti-arrhythmic and anti-coagulation medication

• Query regarding recurrence or repeat ablation for typical atrial flutter ;

Related Conditions & MeSH terms

• Atrial Flutter
• Typical Atrial Flutter

• NCT number: NCT01401361
• Study type: Interventional
• Source: Abbott Medical Devices
• Status: Completed
• Phase: Phase 3
• Start date: October 2011
• Completion date: September 2012