EnSite™ HD Grid Catheter AF/AT Mapping Study
|ClinicalTrials.gov Identifier: NCT02656537|
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : February 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non-paroxysmal Atrial Fibrillation Left Atrial Tachycardia||Device: EnSite™ HD Grid Catheter mapping system||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||EnSite™ HD Grid Catheter Mapping System for Advanced High Density Three-Dimensional Mapping in Non-Paroxysmal Atrial Fibrillation and Atrial Tachycardia|
|Actual Study Start Date :||August 2015|
|Actual Primary Completion Date :||February 2018|
|Actual Study Completion Date :||August 2018|
|Experimental: EnSite™ HD Grid Catheter AF/AT Mapping||
Device: EnSite™ HD Grid Catheter mapping system
- Number of subjects with adverse events associated with the use of the EnSite™ HD (High-Density)Grid Catheter mapping system. [ Time Frame: Within 48 hours from Procedure ]To evaluate the safety of the novel EnSite™ HD Grid Catheter mapping system by collecting intra- and post-Procedure (within 48 hours from Procedure) adverse events.
- Number of subjects with the electrophysiological characteristics of non-paroxysmal AF and left AT pre-catheter ablation studied using the EnSite™ HD Grid Catheter mapping system. [ Time Frame: During Procedure ]To identify and study the electrophysiological characteristics of non-paroxysmal AF and left AT pre-catheter ablation using a novel EnSite™ HD Grid Catheter mapping system.
- Catheter performance during the mapping portion of the procedure [ Time Frame: During Procedure ]To assess the HD Grid Catheter mapping system for acceptable geometry creation, map repeatability and electrogram signal quality.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656537
|Royal Adelaide Hospital|
|Ashford, Australia, 5035|
|Royal Melbourne Hospital|
|Parkville, Australia, 3050|
|Hôpital du Haut Lévêque|
|Pessac, France, 33604|
|Herzzentrum Dresden GmbH Universitatsklinik|
|Dresden, Germany, 01307|
|Queen Mary Hospital|
|Hong Kong, Hong Kong|
|San Donato Hospital|
|Principal Investigator:||Carlo Pappone, MD, PhD||San Donato Hospital, Italy|