Atrial fibrillation heartfailure
Conditions
Interventions
all patients will undergo either PVI or atrioventricular node ablation.
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Presence of a cardiac resynchronization therapy device (CRT-D or CRT-P) and optimal medical therapy according to current guidelines. • Patients with paroxysmal or persistent AF, having AF or HF related symptoms. • Patient with paroxysmal AF should have >25% burden or inadequate biventricular pacing (= 18 years
Exclusion criteria
Exclusion criteria: • Documented left atrial diameter > 6 cm (parasternal long axis). • Longstanding persistent AF longer than 2 years. • Contraindication to chronic anticoagulation therapy or heparin • Previous left heart ablation procedure for AF • Acute coronary syndrome, cardiac surgery, angioplasty or stroke within 2 months prior to enrolment • Untreated hypothyroidism or hyperthyroidism • Enrolment in another investigational drug or device study. • Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age. • Mental or physical inability to participate in the study. • Listed for heart transplant. • Cardiac assist device implanted. • Planned cardiovascular intervention. • Life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point is defined as the hierarchical occurrence of all-cause death, cardiovascular hospitalization (heart failure or stroke), and the change in quality of life at 1 year. | — |
Secondary
| Measure | Time frame |
|---|---|
| Death from any cause, unplanned hospitalization related to heart failure, death from cardiovascular disease, cerebrovascular accident, unplanned hospitalization for cardiovascular disease, and any hospitalization. Furthermore changes in the Kansas city cardiomyopathy questionnaire were assessed. Also procedure related adverse events and atrial fibrillation-free intervals were assessed. | — |
Countries
Netherlands
Outcome results
None listed