High-Density (HD) Wave Mapping in Subjects With Atrial Fibrillation as a Predictor of Recurrence After a Single Ablation Procedure Using a PVI-Only Strategy

N/ACompletedNCT03882021

Abbott Medical Devices300 enrolled

Overview

The aim is to use the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ to characterize the atrial substrate and develop a model for predicting recurrence rates after a single procedure using a PVI only approach and a contact catheter.

This clinical investigation is intended to characterize the left atrial substrate using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ in an HD Wave configuration and correlate different factors with 12-month success after a single ablation procedure using a pulmonary vein isolation (PVI) approach without further substrate modification. This is a post-market, single-arm, multi-center, prospective interventional study of the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™. This study is aimed at determining correlations between pre-ablation mapping characteristics and outcomes after catheter ablation of atrial fibrillation. Approximately 300 subjects at up to 20 sites worldwide will be enrolled. Subjects will be followed until they complete their 12-month visit. Clinical Investigation visits will occur at Baseline (confirmation of eligibility), Index Procedure, 3 months, 6 months, and 12 months. Endpoints will be analyzed when all subjects have completed their 12-month follow up visits.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

300

Conditions

Paroxysmal Atrial Fibrillation Persistent Atrial Fibrillation Cardiac Arrhythmia

Interventions

A specific electrophysiology mapping protocol is applicable with the GRID catheter.PROCEDURE

The procedure will be done according to a standard ablation approach. During the electrophysiology study, additional mapping data will be collected to support the study endpoints using the GRID catheter.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Documented atrial fibrillation with planned endocardial ablation procedure 2. Age 18 years or older 3. Able and willing to provide written informed consent prior to any clinical investigation related procedure 4. Able and willing to complete all required study procedures through 12 months Exclusion Criteria: 1. Long-standing persistent atrial fibrillation defined as continuous AF greater than 12 months in duration 2. Previous ablation or surgery in the left atria 3. Implanted left atrial appendage occluder 4. Implanted mitral or tricuspid valve replacement 5. Implanted cardiac defibrillator (ICD) 6. Participation in another clinical investigation that may confound the results of this study 7. Pregnant or nursing 8. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results. 9. Life expectancy less than 12 months

Locations (15)

Kepler Universitätsklinikum GmbH

Linz, UPR AUS, Austria

FN U sv. Anny v Brno

Brno, Moravia-Silesia, Czechia

CHR de La Reunion - Site du CHFG

Outcomes

Primary Outcomes

Percentage of Subjects With One-year Success

Defined as freedom from atrial fibrillation, atrial flutter and atrial tachycardia after removal from the antiarrhythmic drug therapy as assesses from the end of the 3-month blanking period to 12 months following a single ablation procedure. Kaplan-Meier survival analysis will be conducted to analyze time-to-event variables.

Time frame: the end of the 3-month blanking period to 12 months following a single ablation procedure

Data from ClinicalTrials.gov

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