To identify predictors of success of AF ablation including clinical factors, AF recurrence patterns, anatomical and electrophysiological characteristics, circulating biomarkers and individual genetic background.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Cardiac therapeutic procedures
Synonym
Research involving
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 defined as AF, atrial tachycardia (AT) and non-isthmus
dependent atrial flutter (AFl). Following the current guidelines, episodes of
atrial arrhythmia should be documented on ECG, on Holter monitoring (minimum
duration of 30 seconds), or on an implanted device (atrial high rate episode
during at least 5 minutes or mode switch, and confirmed as being AF or other
atrial arrhythmia by a trained physician).
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
Although ablation is a common step in the treatment for atrial fibrillation
(AF), the procedure does not have the intended effect in about one third of
patients. Despite several well-known clinical predictors, it remains a
challenge to identify patients at risk for ablation failure with satisfactory
certainty.
Study objective
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 cohort study 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 prior to the ablation,
lean body mass index, 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 burden and risks
Participation in this study requires no additional visits to the outpatient
clinic. Standard outpatient clinic visits may be prolonged by 10-20 minutes.
Extended rhythm monitoring and questionnaires are completed at home, these will
take some additional time as well.
Extended rhythm monitoring and questionnaires are not associated with risks.
The extECG might lead to skin irritation due to the additional leads. The blood
samples at baseline are collected together with routine clinical blood tests,
no additional venipuncture is necessary. Blood samples after 3 and 12 months
are taken specifically for the study, these additional venipunctures might be
accompanied by hematomas. The LAA biopsy is performed after clipping of the LAA
and is not associated with increased risks. The epicardial electroanatomical
mapping during hybrid procedures extends the procedure (and thus time on single
lung ventilation) with 10-15 minutes.
The TE-ECG is performed in patients from whom additional consent is obtained.
The insertion of the TE-ECG probe can be unpleasant for the patient, but
serious complications have not been observed until now. Previous studies report
complications in 0-1,4% of patients, mostly atrial arrhythmias. The ablation
itself is clinically indicated and performed as standard practice following a
routine protocol. No specific recommendations for the procedure itself,
management and/or treatment after the procedure will be given during this
registry.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
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;
• Emergency procedures.
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.
Epicardial mapping is only performed in the subset of patients undergoing
hybrid ablation or surgical ablation. A subject who meets any of the following
criteria will be excluded for this additional procedure:
• COPD Gold II, III, or IV;
• Heart failure, currently in NYHA class III or IV;
• Any other pulmonary, cardiac, or other condition that may compromise a safe
conduct of epicardial mapping in the opinion of the treating physician or
investigator, taking the prolonged duration of single lung ventilation into
account.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL70787.068.19 |
| Other | NL7894 (Netherlands Trial Register), NCT04342312 (clinicaltrials.gov) |
| OMON | NL-OMON20836 |