No registrations found.
ID
Source
Brief title
Health condition
Atrial fibrillation
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is ablation success, defined as freedom from documented recurrence of atrial arrhythmia after 12 months. Recurrences in the first 3 months after the index procedure (blanking period) are exempted. Atrial arrhythmias are atrial fibrillation (AF), atrial tachycardia (AT) and non-isthmus dependent atrial flutter (AFl), lasting more than 30 seconds, documented on electrocardiogram (ECG) or Holter monitoring.
Secondary outcome
· Time to recurrence of atrial arrhythmia after the blanking period.
· Time to recurrence of AF after the blanking period.
· Early AF recurrences, defined as any episode of AF during the blanking period.
· Early recurrences of atrial arrhythmia, defined as any episode of AF, AT or non-isthmus dependent AFl during the blanking period.
· Changes in circulating biomarkers and non-invasive electrophysiological markers for substrate quantification.
· Use of antiarrhythmic drugs (AADs) one year after ablation.
· Redo procedures, defined as repeated ablation procedure with the goal to prevent recurrence of AF or reduce the AF burden after one or more previous attempts to achieve the same goal.
· Number of veins with pulmonary vein reconnection at redo procedure.
· Major adverse cardiovascular events (MACE).
Background summary
Rationale
Although there are several individual factors which are known to influence the chances of successful atrial fibrillation (AF) ablation, it remains a challenge to identify patients at risk for ablation failure with satisfactory certainty.
Objectives
To identify predictors of success of AF ablation including clinical factors, AF recurrence patterns, anatomical and electrophysiological characteristics, circulating biomarkers and individual genetic background.
Study design
Prospective registry of patients undergoing AF ablation. Clinical characteristics and results of routine tests are collected. In addition, the following (non-standard) tests are performed: extended surface electrocardiogram (extECG), extended rhythm monitoring, biomarker testing, genetic analysis, questionnaires. In subgroups of patients transesophageal electrocardiogram (TE-ECG), epicardial electroanatomical mapping and/or left atrial appendage (LAA) biopsy is performed.
Study population
Patients aged 18 years and older with documented AF, scheduled for AF ablation.
Main study endpoints
Ablation success after 12 and 24 months, defined as freedom from any episode of documented atrial arrhythmia after the blanking period.
Study objective
It is the aim of this study to establish an integrated risk profile including clinical risk factors, AF recurrence patterns, anatomical and electrophysiological characteristics, circulating biomarkers and individual genetic background, to predict ablation failure after different ablation techniques.
Study design
Primary endpoint: 12 months after ablation.
Total follow-up duration: 24 months after ablation
Inclusion criteria
In order to be eligible to participate in this registry, a subject must meet all of the following criteria:
· 18 years of age or older;
· Documented atrial fibrillation;
· Scheduled for AF ablation or redo AF ablation;
· Able and willing to provide written informed consent.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this registry:
· Serious patient condition before ablation;
· Physically or mentally unable to provide written informed consent.
A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for transesophageal ECG (TE-ECG) is asked:
· Known esophageal disease;
· Previous surgery on esophagus, throat or stomach;
· Recent (<4 weeks) myocardial infarction;
· Unwilling to provide additional informed consent.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7894 |
| CCMO | NL70787.068.19 |
| OMON | NL-OMON52886 |