Atrial Fibrillation, Heart Failure
Conditions
Brief summary
Pulmonary vein isolation (PVI) is currently the cornerstone non pharmacological therapy for drug-refractory atrial fibrillation (AF). Where rhythm control has been shown to be inferior as compared to rate control in older trials. New data suggest that for patients with heart failure and AF PVI may improve prognosis (mortality) as compared to medical rate or rhythm control. Whether optimal rate control as can be achieved with atrioventricular node ablation is comparable with regard to all-cause mortality of heart failure hospitalization to PVI in patients with heart failure and AF is unknown.
Interventions
PROCEDUREAblation
Ablation of either the pulmonary veins or the atrioventricular node
Sponsors
University Medical Center Groningen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 (\<95%) based on device counters. * The patient is willing and able to comply with the protocol and has provided written informed consent. * Age ≥ 18 years
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 ≤ 12 months. * Uncontrolled hypertension. * Requirement for dialysis due to terminal renal failure. * Participation in another telemonitoring concept
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause death. | 1 year | Occurence of all-cause death. |
| cardiovascular hospitalization. | 1 year | Occurence of cardiovascular hospitalization (heart failure or stroke). |
| Quality of life | 1 year | Change in quality of life (using the Kansas City Cardiomyopathy Questionnaire (KCCQ)). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cerebrovascular accident. | 1 year | Occurence of stroke. |
| unplanned hospitalization for cardiovascular disease | 1 year | Any unplanned hospitalization for cardiovascular disease. |
| Any hospitaliation | 1 year | Any hospitalization for non-cardiovascular disease. |
| Death from any cause | 1 year | Occurence of death from any cause. |
| procedure related adverse events | 1 year | Occurence of procedure related adverse events. |
| atrial fibrillation-free intervals were assessed. | 1 year | Assessment of AF free intervals. |
| changes in the Kansas city cardiomyopathy questionnaire | 1 year | Changes in quality of life (any) |
| Unplanned hospitalization | 1 year | Occurence of unplanned hospitalization related to heart failure. |
| death from cardiovascular disease | 1 year | Occurence of death from cardiovascular disease. |
Countries
Netherlands
Outcome results
None listed