Identification of a risk profile to guide atrial fibrillation therapy in patiens with AF

Identification of a risk profile to guide atrial fibrillation therapy in patiens with AF - Risk stratification in AF

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON37361

Enrollment

500

Registered

2011-11-08

Start date

2011-11-25

Completion date

Unknown

Last updated

2024-05-06

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: - Symptomatic paroxysmal or (long-standing) persistent AF; - Rhythm control strategy is preferred; - No contra-indication for oral anticoagulation; - Age > 18 years; - Written informed consent.

Exclusion criteria

Exclusion criteria: - Total history of heart failure and/ or of severe valvular disease > 10 years; - Severe valvular disease; - Acute coronary syndrome/ myocardial infarction/ percutaneous coronary intervention/ coronary artery bypass surgery within the past one month; - Post-operative AF.

Design outcomes

Primary

Measure	Time frame
Primary objective: To assess the risk profile associated with success of rhythm control therapy at 12 months of follow-up, i.e. all of the following: (1)	—

Secondary

Measure	Time frame
1. To assess the risk profile associated with recurrence of (a)symptomatic AF; 2. To assess the risk profile associated with failure of rhythm control therapy, i.e. persistent or permanent AF after 1 year; 3. To assess the recurrence and/or progression of cardiac remodeling in AF during follow-up measured with use of echocardiography (atrial sizes, ventricular function); 4. To study pathophysiological mechanisms of AF, e.g. collagen mediated, inflammation mediated AF, or other mechanisms; 5. To assess the risk profile associated with early ( after 4 weeks) AF recurrences; 6. To relate risk profiles with cardiovascular morbidity and mortality; 7. To assess the risk profile associated with success of pulmonary vein ablation; 8. To study differences in clinical outcome between patients presenting at the emergency room and outpatient department. 9. To assess differences in clinical characteristics (e.g. severity of complaints, heart rate during AF, ventricular function) between patients included in the emergency department versus the outpatient clinic. 10. To assess prognostic parameters predicting the occurrence of the combined endpoint of heart failure hospitalization or stroke or all-cause mortality in patients with atrial fibrillation and heart failure. 11. To assess structural and functional changes by echocardiography in patients with atrial fibrillation and heart failure and AF.	—

Measure

Time frame

1. To assess the risk profile associated with recurrence of (a)symptomatic AF; 2. To assess the risk profile associated with failure of rhythm control therapy, i.e. persistent or permanent AF after 1 year; 3. To assess the recurrence and/or progression of cardiac remodeling in AF during follow-up measured with use of echocardiography (atrial sizes, ventricular function); 4. To study pathophysiological mechanisms of AF, e.g. collagen mediated, inflammation mediated AF, or other mechanisms; 5. To assess the risk profile associated with early ( after 4 weeks) AF recurrences; 6. To relate risk profiles with cardiovascular morbidity and mortality; 7. To assess the risk profile associated with success of pulmonary vein ablation; 8. To study differences in clinical outcome between patients presenting at the emergency room and outpatient department. 9. To assess differences in clinical characteristics (e.g. severity of complaints, heart rate during AF, ventricular function) between patients included in the emergency department versus the outpatient clinic. 10. To assess prognostic parameters predicting the occurrence of the combined endpoint of heart failure hospitalization or stroke or all-cause mortality in patients with atrial fibrillation and heart failure. 11. To assess structural and functional changes by echocardiography in patients with atrial fibrillation and heart failure and AF.

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Countries

Netherlands

Outcome results