Identification of a risk profile to guide atrial fibrillation therapy in patiens with AF
Completed
- Conditions
- atrial fibrillation10007521
- Registration Number
- NL-OMON37361
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 500
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
- 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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary objective:<br /><br>To assess the risk profile associated with success of rhythm control therapy at<br /><br>12 months of follow-up, i.e. all of the following: (1) < 1 second AF on ECG;<br /><br>(2) < 30 seconds AF on 24 hour Holter recording and (3) no symptoms of AF.<br /><br><br /><br>Co- primary objective: To assess the risk profile associated with success of<br /><br>rhythm control therapy at 60 months of follow-up, i.e. all of the following:<br /><br>(1) < 1 second AF on ECG; (2) < 30 seconds AF on 24 hour Holter recording and<br /><br>(3) no symptoms of AF.</p><br>
- Secondary Outcome Measures
Name Time Method