Atrial fibrillation. i.e. the heart's upper chambers (the atria) beating very rapidly and irregularly resulting in an irregular pulse
Conditions
Interventions
Patients will be randomized to early therapy or usual care. In the early
therapy group, patients will receive either catheter ablation (usually by
pulmonary vein isolation), or adequate antiarrhythm
Sponsors
Kompetenznetz Vorhofflimmern e.V., AFNET e.V., Germany
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Recent onset AF, i.e. AF with a known history of 75 years, prior stroke or transient ischemic attack (TIA) OR b) two of the following: hypertension, diabetes mellitus, left ventricular hypertrophy, age > 65 years, female sex, peripheral artery disease, kidney disease (MDRD stage III or IV), stable heart failure (NYHA II or LVEF
Exclusion criteria
Exclusion criteria: 1. prior AF ablation or surgical therapy of AF 2. patients not suitable for rhythm control of AF 3. severe mitral valve stenosis 4. prosthetic mitral valve
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A composite of cardiovascular death, stroke / transient ischemic attack (TIA), and hospitalization due to worsening of heart failure or due to acute coronary syndrome. The 1st co-primary outcome parameter is defined as the time to the first occurrence of a composite of the above mentioned components. The 2nd co-primary outcome is nights spent in hospital per year. | — |
Secondary
| Measure | Time frame |
|---|---|
| Several secondary outcomes will be assessed in the study population. Key secondary outcomes: Each of the components of the primary outcome, time to recurrent AF, cardiovascular hospitalizations, all-cause hospitalizations, left ventricular function, quality of life, cognitive function, cost of therapy. These and additional secondary outcome parameters will be assessed in the main trial and in investigator driven sub-studies. Assessment of safety: The primary safety outcome comprises all deaths, the components of the primary efficacy parameter plus other adverse events related to the study intervention with special emphasis on proarrhythmia and complications due to interventions. | — |
Countries
Netherlands
Outcome results
None listed