NCT03882021

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Paroxysmal Atrial Fibrillation
• Persistent Atrial Fibrillation
• Cardiac Arrhythmia

Interventions

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

Timeline

• Start date: 2019-08-26
• Primary completion: 2021-11-30
• Completion: 2022-01-13
• First posted: 2019-03-20
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

15 sites across 9 countries: Austria, Czechia, France, Germany, Italy, Netherlands, Portugal, Spain, United Kingdom