NCT02656537

EnSite™ HD Grid Catheter AF/AT Mapping Study

EnSite™ HD Grid Catheter Mapping System for Advanced High Density Three-Dimensional Mapping in Non-Paroxysmal Atrial Fibrillation and Atrial Tachycardia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this clinical investigation, the safety, feasibility and performance of the novel EnSite™ HD Grid Catheter mapping system for advanced high-density three-dimensional mapping will be studied in patients undergoing catheter ablation procedures for the treatment of non-paroxysmal atrial fibrillation (AF) or left atrial tachycardia (AT).

Detailed description

Catheter ablation for non-paroxysmal AF is more complex as triggers, if present at all, are not immediately apparent, but the abnormal atrial substrates are the likely predominant mechanisms. Additional catheter ablation strategies targeting for atrial substrate modification have been introduced. The common strategies involve either application of empirical linear lesion sets in the atrial areas or ablation of atrial areas with complex fractionated atrial electrograms in addition to pulmonary vein isolation. Nevertheless, the corresponding success rates in long-term sinus rhythm maintenance are modest. Non-paroxysmal AF and left AT are characterized by fast and regular atrial activities, complex fractionated atrial electrograms, consistent direction of wave front propagation, and low peak-to-peak voltage. Advanced high-density three-dimensional catheter mapping strategies to target the evaluation of these characteristics and mechanisms responsible for the AF and left AT, identification of atrial areas with low peak-to-peak voltages and determination of the "critical" atrial targets for catheter ablation during the procedures would be essential. In this clinical investigation, the safety, feasibility and performance of the novel EnSite™ HD Grid Catheter mapping system for advanced high-density three-dimensional mapping will be studied in patients undergoing catheter ablation procedures for the treatment of non-paroxysmal AF or left AT.

Conditions

• Non-paroxysmal Atrial Fibrillation
• Left Atrial Tachycardia

Interventions

Type	Name	Description
DEVICE	EnSite™ HD Grid Catheter mapping system

Timeline

• Start date: 2015-08-01
• Primary completion: 2018-02-01
• Completion: 2018-08-01
• First posted: 2016-01-15
• Last updated: 2019-02-01

Locations

7 sites across 5 countries: Australia, France, Germany, Hong Kong, Italy