Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-09 @ 8:18 AM
Study NCT ID:
NCT02571218
Status:
COMPLETED
Last Update Posted:
2019-07-05
First Post:
2015-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
AF Substrate Mapping and Guided Ablation
Sponsor:
Abbott Medical Devices
Organization:
Study Overview
Official Title:
Substrate-Targeted Catheter Ablation to Treat Persistent Atrial Fibrillation
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: