NCT01401361

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Typical Atrial Flutter

Interventions

Type	Name	Description
DEVICE	Treatment Arm	The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-04-01
• Completion: 2012-09-01
• First posted: 2011-07-25
• Last updated: 2019-02-15
• Results posted: 2013-12-23

Locations

20 sites across 2 countries: United States, Canada