Atrial Fibrillation Ablation Registry
AFAB
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
1 other identifier
observational
1,250
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 12, 2017
CompletedFirst Submitted
Initial submission to the registry
March 6, 2017
CompletedFirst Posted
Study publicly available on registry
March 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedFebruary 20, 2020
February 1, 2020
5 years
March 6, 2017
February 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
AF characteristics
12 months
ECG AF characteristics
3 months
ECG to BSPM discriminative power
12 months
Study Arms (2)
Extended Electrocardiogram
Elective patients receiving an AF ablation receiving a extended ECG
Body surface potential map
Elective patients receiving an AF ablation receiving a body surface potential map
Interventions
ECG with 3 additional leads and a 5 minute recording
ECG with 184 leads and a 5 minute recording
Eligibility Criteria
Patients referred for ablation of AF with a history of self-terminating or persistent non-valvular AF with at least one documented AF episode during the last 6 months
You may qualify if:
- 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
You may not qualify if:
- Emergency ablation
- Serious patient condition before ablation
- Physically or mentally unable to provide written informed consent
- Permanent atrial fibrillation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maastricht University Medical Centerlead
- RWTH Aachen Universitycollaborator
Study Sites (1)
Maastricht University
Maastricht, Limburg, 6229HX, Netherlands
Biospecimen
Probes of blood for common gene variant analysis
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Laurent Pison, Physician
Maastricht University
- PRINCIPAL INVESTIGATOR
Ulrich Schotten, Physician
Maastricht University
- STUDY DIRECTOR
Matthias D Zink, Physician
Maastricht University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 6, 2017
First Posted
March 9, 2017
Study Start
January 12, 2017
Primary Completion
January 1, 2022
Study Completion
January 1, 2023
Last Updated
February 20, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- In case of an extend to another participating center IPD are available for the collaborating center.
- Access Criteria
- In case of an extend to another participating center IPD are available for the collaborating center.
This study is planned as a Single Center Study. But it could be possible to extend it to other centers. In this case data will be shared with the participating centers.