AF Substrate Mapping and Guided Ablation

Persistent Atrial Fibrillation Clinical Trial

Official title:

Substrate-Targeted Catheter Ablation to Treat Persistent Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02571218
• Other study ID #: SJM-CIP-10054
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: February 2017

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 18 - 85 years of age

• Persistent AF scheduled to undergo catheter ablation with approved standard indication by ESC/EHRA guidelines

• First or second time ablation for persistent AF

• Ability to provide written informed consent for study participation and be willing and able to comply with the study evaluations and follow up schedule

Exclusion Criteria:

• Had two or more previous AF ablation procedures

• Secondary AF

• Hyperthyroidism

• Left ventricular ejection fraction <30%

• NYHA functional class IV

• Left atrial area > 35 cm2

• Uncorrected severe valvular heart disease

• Contraindication to anticoagulation

• Presence of left atrial thrombus

• Recent (<6 Months) myocardial Infarction or unstable angina or coronary artery by-pass

• Thoracic surgery for congenital, valvular or aortic disease

• History of cerebrovascular accidents

• Pregnancy

• Significant comorbidities such as cancer, severe renal insufficiency requiring hemodialysis, severe obstructive lung disease, cirrhosis, with a life expectancy less than 2 years

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Device:
• Substrate+mCPVA
The intervention in the experimental arm includes using a research software (investigational device) to map AF substrate and guide ablation.
• 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.

Locations

Country	Name	City	State
Italy	I.R.C.C.S. Policlinico San Donato	San Donato Milanese	MI

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term Clinical Success Rate	Freedom from symptomatic AF off antiarrhythmic drug therapy assessed from the end of the 3 months blanking period to 12 months following the ablation procedure, documented by implantable loop recorder (ILR) monitoring or trans-telephonic (TT) ECG monitoring.	12 months
Secondary	Acute Ablation Procedure Outcome	Acute AF termination or significant AF cycle length slowing during RF application in ablation procedure	During Ablation