EnSite™ HD Grid Catheter AF/AT Mapping Study

Abbott Medical Devices82 enrolled

Overview

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).

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

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Non-paroxysmal Atrial Fibrillation Left Atrial Tachycardia

Interventions

EnSite™ HD Grid Catheter mapping systemDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Presence of non-paroxysmal atrial fibrillation (AF) or left atrial tachycardia (AT) referred for catheter ablation 2. Age of 18 years of age or older at time of Enrollment 3. On continuous anticoagulation (INR 2-3) for \>4 weeks prior to the ablation 4. Able and willing to provide written informed consent to participate in this clinical investigation Exclusion Criteria: 1. Secondary atrial fibrillation (AF) 2. Presence of a prosthetic valve(s) or hemodynamically significant valvular heart disease as determined by Study Investigator 3. Active systemic infection (e.g. sepsis) 4. Presence of left atrial thrombus (i.e., positive TEE) or myxoma, or interatrial baffle or patch via the transseptal approach 5. Contraindication to systemic anticoagulation (i.e., heparin, warfarin, or a direct thrombin inhibitor) 6. History of cerebrovascular accidents (Stroke, TIA) 7. Previous myocardial infarction, unstable angina pectoris or coronary artery by-pass \<180 days at Enrollment or cardiovascular intervention expected in the 180 days post-Enrollment 8. Left atrial size \>55mm 9. NYHA (New York Heart Association Classification) functional class III or IV heart failure 10. Left ventricular ejection fraction \<35% 11. Uncontrolled Hyperthyroidism 12. Pregnant or of childbearing potential and not using adequate contraceptive methods or nursing 13. Participating in another clinical investigation that may confound the results of this clinical investigation 14. Life expectancy less than 12 months, as determined by Study Investigator 15. Severe clinical condition (e.g. active carcinoma) that, in the opinion of the Study Investigator, excludes the participation in the study

Locations (7)

Royal Adelaide Hospital

Adelaide, Australia

Ashford Hospital

Ashford, Australia

Royal Melbourne Hospital

Parkville, Australia

Hôpital du Haut Lévêque

Pessac, France

Outcomes

Primary Outcomes

Number of subjects with adverse events associated with the use of the EnSite™ HD (High-Density)Grid Catheter mapping system.

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.

Time frame: Within 48 hours from Procedure

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.

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.

Time frame: During Procedure

Catheter performance during the mapping portion of the procedure

To assess the HD Grid Catheter mapping system for acceptable geometry creation, map repeatability and electrogram signal quality.

Time frame: During Procedure

Data from ClinicalTrials.gov

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