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…
ID
Bron
Verkorte titel
Aandoening
Atrial fibrillation
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
Primary endpoint: 12 months after ablation.
Total follow-up duration: 24 months after ablation
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7894 |
| CCMO | NL70787.068.19 |
| OMON | NL-OMON52886 |