Identification of a Risk Profile Associated with Failure of the Cryoballoon Ablation of Atrial Fibrillation; a Multicenter Explorative Registry.

Identification of a Risk Profile Associated with Failure of the Cryoballoon Ablation of Atrial Fibrillation; a Multicenter Explorative Registry. - Cryoballoon AF Ablation.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46840

Enrollment

600

Registered

2015-09-30

Start date

2018-10-31

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: 1. Patients who had a prior ablation treatment because of atrial fibrillation.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results