The primary aim of the present registry is to assess a risk profile including biomarkers and genetics, associated with failure of the cryoballoon AF ablation, so we can predict failure of the cryoballoon AF ablation. Failure will be assessed within…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to assess a risk profile, including circulating
biomarkers and genetic background, associated with failure of the cryoballoon
AF ablation, i.e. any (a)symptomatic AF/AFL/AT >30 sec without anti-arrhythmic
drugs determined within 1 year of follow-up by ECG recording and 1-day Holter
monitoring.
Secondary outcome
Secondary outcomes concern the identification of a risk profile associated with
(long term) failure or success of the procedure; the number of patients
requiring repeat baltaion following cryoballoon AF ablation; the
electrophysiological findings during the (redo) procedure; procedural
predictors of succes of the cryoballoon AF ablation; the incidence and type of
supraventricular tachyarrhythmia*s following the procedure; the occurence of
major cardiac and cardiovascular events; safety of the cryoballoon AF ablation;
changes in left atrial size and function following ablation; the degree of
epicardial adipose tissue; the use of anti-arrhythmic drugs; the frequency of
repeated ablations; quality of life and physical activity.
Background summary
Outcome of rhythm control therapy depends on the severity of atrial
fibrillation (AF), i.e. atrial (electrical/mechanical/structural) remodeling.
Beside echocardiographic markers of atrial structural remodeling, atrial
remodeling also seems to be represented by circulating biomarkers. Catheter
ablation of atrial fibrillation by pulmonary vein isolation (PVI) is an
established therapy for patients with symptomatic atrial fibrillation.
Currently, different catheters are available for ablation of the pulmonary
veins. The cryoballoon catheter is an established ablation technique with good
documented efficacy and safety rates in patients with atrial fibrillation. In
patients where the cryoballoon ablation has not been successful, this is
probably due to the underlying substrate of the arrhythmia, including fibrosis
of the atria. We hypothesize that the severity of atrial remodeling in patients
with AF can be measured by clinical factors, echocardiographic parameters,
circulating biomarkers and genetic background, and that these factors can be
used to identify a risk profile to predict failure of the cryoballoon AF
ablation therapy.
Study objective
The primary aim of the present registry is to assess a risk profile including
biomarkers and genetics, associated with failure of the cryoballoon AF
ablation, so we can predict failure of the cryoballoon AF ablation. Failure
will be assessed within one year of follow-up using ECG and 1-day Holter
monitoring. In addition patients eligible for the cryoballoon AF ablation
procedure will be asked to undergo extra blood analysis for determining
biomarkers and genetics.
Study design
A prospective multicenter registry.
Study burden and risks
Extra (study-related) investigations consist of blood sampling for biomarker
and genetic analysis at baseline, questionnaires for quality of life and
physical activity at baseline, and at 1 and 5 year of follow-up, and telephone
consultation to collect data at 3 and 5 year of (long-term) follow-up. Extra
visits to the outpatient clinic will not be necessary. At baseline blood
samples for biomarkers are collected together with blood sample collection for
routine clinical care, so no additional venipuncture will be necessary. Risks
of the (study related) investigations are negligible.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
1. Patients who have agreed to undergo the cryoballoon ablation procedure for atrial fibrillation.
2. Age >18 years.
3. Written informed consent.
Exclusion criteria
1. Patients who had a prior ablation treatment because of atrial fibrillation.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL53511.042.15 |