EnSite™ HD Grid Catheter AF/AT Mapping Study

Non-paroxysmal Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02656537
• Other study ID #: CRD772
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: August 2018

Study information

• Verified date: January 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: August 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Left Atrial Tachycardia
• Non-paroxysmal Atrial Fibrillation
• Tachycardia

Intervention

Device:
• EnSite™ HD Grid Catheter mapping system

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide
Australia	Ashford Hospital	Ashford
Australia	Royal Melbourne Hospital	Parkville
France	Hôpital du Haut Lévêque	Pessac
Germany	Herzzentrum Dresden GmbH Universitatsklinik	Dresden
Hong Kong	Queen Mary Hospital	Hong Kong
Italy	San Donato Hospital	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Australia,  France,  Germany,  Hong Kong,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 48 hours from Procedure
Primary	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.	During Procedure
Primary	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.	During Procedure