Atrial Fibrillation Ablation Registry

Atrial Fibrillation Recurrent Clinical Trial

— AFAB  

Official title:

A Registry With the Aim to Identify Characteristics of Atrial Conduction and Risk of Recurrence in Patients With Atrial Fibrillation Undergoing Ablation for Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03075930
• Other study ID #: METC 16-4-208
• Status: Recruiting
• Start date: January 12, 2017
• Est. completion date: January 2023

Study information

• Verified date: February 2020
• Source: Maastricht University Medical Center
• Contact: Matthias D Zink, Physician
• Phone: 00491797523510
• Email: m.zink[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is a single centre prospective data registry. In this study atrial conduction characteristics of extended surface Electrocardiograms (esECG), biomarkers and genetic analysis will be performed before ablation, before discharge and 3 months after catheter ablation of atrial fibrillation (AF) and compared to routine clinical follow-up data.

The objective of this registry is to establish a data registry of patients undergoing ablation of AF. Supplementary to the routine clinical diagnostic an esECG and an analysis of biomarkers will be performed and compared to clinical and outcome data.

Description:

Electro anatomical remodelling of the atria due to ageing or structural heart disease leads to AF which in turn leads to cardiac electrical and structural remodelling. In case of advanced remodelling restoration of sinus rhythm (SR) becomes more difficult and the results of catheter ablation are disappointing. Furthermore, there is no valid parameter to predict or diagnose recurrence of AF during SR after successful ablation, so repeated long-term electrocardiogram (ECG) recordings have to be performed to detect asymptomatic AF episodes in particular.

Thus, the rationale to establish a systematic review of patient data in a registry are:

• Self-termination AF leads to slight, persistent AF leads to more advanced cardiac remodelling, shown in altered atrial conduction properties

• Early recognition and therapy of AF improves the outcome, thus clinical parameter to predict or diagnose recurrence of AF during SR are desirable Ablation of AF is predominantely performed using standard endocardial transvenous technique of pulmonary veins isolation (PVI) by radiofrequency or cryoballoon ablation. For medical reasons specific ablation techniques like additional ablation lines or an epicardial approach is in discretion of the treating cardiologist. The esECG is measured by signal averaged routine 12-lead ECG with 3-5 supplementary leads before ablation, before discharge and 3 months after ablation. 2 tubes of EDTA plasma will be taken supplementary during routine venous puncture on admission and analysed for biomarkers and common gene variants.

During 5 years every participant receives an esECG before ablation, before discharge and three months after ablation. Routine follow-up data of each participant is included until 12 months of follow-up.

Patients who are included would also undergo a procedure without participation in this study. Risks (complications of procedures) are associated with the procedure and not with participation in the registry. The supplementary diagnostics performed for the registry are comprehensible to clinical routine ECG diagnostics. Extra (study-related) investigations consist of esECG (a signal averaged surface ECG with 3-5 supplementary leads at baseline before ablation), before discharge, and 3 months after ablation, and possibly also a body surface potential map (BSPM). These are always planned together with routine follow-up, no extra visits are necessary. The esECG and BSPM can be compared to regular ECGs, the only additional discomfort might be the number of leads. Furthermore 2 tubes of EDTA plasma blood will be taken supplementary at the routine admission venous puncture for further biomarker and common gene variants analysis.

Quality assurance plan: All data will be stored in 2 independent database. In the first database personal and contact informations are stored with a decent patient ID number in ascending order. In the other database all medical informations will be stored without personal data of the patient. The database has algorithm to prevent mesenteries and rudimentary checks for data integrity and consistency. List are provided for repeated parameters and all variables are explained if relevant. Standard operating procedures are provided for relevant steps in patient inclusion, measurements and data entry.

Because of the registry character no sample size calculation is provided yet. But after the first year of inclusion a data analysis will provide informations about an expected sample size. To date we calculate for an period of patient inclusion of 5 years.

Data inconsistency could not be avoided due to the registry character of this study and will marked in a respective way.

Statistical analysis will be performed after the first year of patients including logistic regression analysis to determine the discriminative power of the recorded ECG for the clinical outcome and recurrence of AF.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1250
• Est. completion date: January 2023
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Documented self-terminating or persistent AF

• Scheduled for ablation of AF

• At least 18 years of age, mentally able and willing to give informed consent

Exclusion Criteria:

• Emergency ablation

• Serious patient condition before ablation

• Physically or mentally unable to provide written informed consent

• Permanent atrial fibrillation

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation (Paroxysmal)
• Atrial Fibrillation Common Gene Variants
• Atrial Fibrillation Recurrent

Intervention

Device:
• Extended Electrocardiogram
ECG with 3 additional leads and a 5 minute recording
• Body surface potential map
ECG with 184 leads and a 5 minute recording

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	RWTH Aachen University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of AF after ablation	The predictive value for recurrence of AF in patients after ablation of AF based on atrial conduction characteristics in electrocardiographic, -anatomical, biomarker and genetic analysis	12 months
Secondary	AF characteristics	Identify characteristics of patients with self-terminating in contrast to patients with persistent AF in the registry data	12 months
Secondary	ECG AF characteristics	Identify changes by ablation and convalescence in the extended surface ECG	3 months
Secondary	ECG to BSPM discriminative power	To compare the registry data with a subgroup analysis receiving additional to the routine diagnostics a body surface potential map (BSPM) and an ECG-Imaging (ECGI)	12 months