NCT02571218

AF Substrate Mapping and Guided Ablation

Substrate-Targeted Catheter Ablation to Treat Persistent Atrial Fibrillation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

In this study, the investigators aim to identify and characterize, by means of an EnSite Velocity Research Software, the electrophysiological characteristics of substrates that sustain AF in patients with persistent AF and to test whether ablation of such patient-specific substrates might improve the acute and long-term success of conventional catheter ablation therapy.

Detailed description

This study is a prospective, single center, randomized, single-blind, controlled, 2-arm parallel group trial in Milan, Italy. The total duration of the study is expected to be 24 months with \~12 months of enrollment. Approximately 80 subjects suffering from persistent AF will be randomized in a 1:1 fashion to the following investigation arms: * Modified circumferential pulmonary vein ablation alone (mCPVA); * Substrate-targeted ablation guided by AF substrate mapping, followed by completion of modified circumferential pulmonary vein ablation (Substrate+ mCPVA) * Ablate the areas that have fast and regular electrical activities, starting from the fastest cycle length (defined by Mean CL in the range of 120-250 milliseconds, and SD CL in the range of 1-30 milliseconds * Ablate the areas that have consistent rotational or focal propagation pattern (defined by conduction velocity vectors) * Ablate the areas that comprises the slow conduction zone of possible arrhythmia circuits * If AF terminates during RF ablation, stimulation protocol will be used to examine if AF is re-inducible. If AF sustains or is re-inducible and physician decides to remap, mapping will be performed again for substrate-targeted ablation. If AF is not re-inducible, mCPVA will be completed Subjects will be followed up at 3, 6, 12 months. The primary objective of the study is to assess acute and long-term outcome of patient-tailored substrate-targeted ablation (Substrate) plus modified circumferential pulmonary vein ablation (Substrate+mCPVA) versus modified circumferential pulmonary vein ablation alone (mCPVA). The secondary objective of the study is to map and characterize electrophysiological substrates during AF, including regular and fast activities, complex fractionated electrograms, wave front propagation directions, and fibrosis.

Conditions

• Persistent Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Substrate+mCPVA	The intervention in the experimental arm includes using a research software (investigational device) to map AF substrate and guide ablation.
DEVICE	mCPVA	The intervention in the active comparator arm includes using the commercially available EnSite Velocity mapping and ablation system for modified circumferential pulmonary vein ablation.

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2015-10-08
• Last updated: 2019-07-05
• Results posted: 2019-07-05

Locations

1 site across 1 country: Italy