Atrial fibrillation and heart failure are two common heart conditions that are associated with an increase in death and suffering. When both of these two conditions occur in a patient the patient's prognosis is poor. These patients have poor life quality and are frequently admitted to the hospital. The treatment of atrial fibrillation in heart failure patients is extremely challenging. Two options for managing the atrial fibrillation are permitting the atrial fibrillation to continue but controlling the heart rate, or to convert the atrial fibrillation rhythm back to normal and try to maintain the heart in sinus rhythm. Until now, the method to keep the patient in normal sinus rhythm is with antiarrhythmic drugs. Studies using antiarrhythmic drugs to control the rhythm failed to show any survival benefit when compared with permitting the patient to be in atrial fibrillation. In the last few years, new development in techniques and technologies now enable catheter ablation (cauterization of tissue in the heart with a catheter) to be a successful treatment in abolishing atrial fibrillation and that this approach is better than antiarrhythmic drug to control the rhythm. However, there has not been any long-term study to determine whether catheter ablation to abolish atrial fibrillation in heart failure patients would reduce mortality or admissions for heart failure. This study is to compare the effect of catheter ablation-based atrial fibrillation rhythm control to rate control in patients with heart failure and high burden atrial fibrillation on the composite endpoint of all-cause mortality and heart failure events defined as an admission to a healthcare facility for \> 24 hours or clinically significant worsening heart failure leading to an intervention (defined as treatment in an emergency department, a same-day access clinic, or an infusion centre) or unscheduled visits to a healthcare provider for administration of an intravenous diuretic and an increase in chronic heart failure therapy. This study may have a dramatic impact on the way the investigators manage these patients with atrial fibrillation and heart failure and may improve the outlook and well being of these patients.
Substudy\_ In a subset of patients, following informed consent, additional data collection will include annual NT-proBNP/BNP measurements, Echocardiogram baseline and annually and 14 Day ECG Continuous Monitoring at six month intervals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
411
Patients randomized to catheter ablation-based AF rhythm control group will receive optimal HF therapy and one or more aggressive catheter ablation, which include PV antral ablation and LA substrate ablation with or without adjunctive antiarrhythmic drug
Patients in the rate control group will receive optimal HF therapy and rate control measures to achieve a resting HR \< 80 bpm and 6-minute walk HR \< 110 bpm.
Instituto de Cardiologia-FUC RS
Porto Alegre, Rio Grande do Sul, Brazil
Libin Cardiovascular Institute of Alberta, Calgary
Calgary, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
Vancouver General
Vancouver, British Columbia, Canada
Royal Jubilee Hospital
Victoria, British Columbia, Canada
Queen Elizabeth II Health Science
Halifax, Nova Scotia, Canada
Hamilton Health Sciences Centre
Hamilton, Ontario, Canada
Kingston General Hospital
Kingston, Ontario, Canada
St. Mary's General Hospital
Kitchener, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
...and 11 more locations
Composite of all-cause mortality and heart failure events
Heart failure event defined as an admission to a healthcare facility for \> 24 hours or clinically significant worsening heart failure leading to an intervention (defined as treatment in an emergency department, a same-day access clinic, or an infusion centre) or unscheduled visits to a healthcare provider for administration of an intravenous diuretic as accepted by FDA and an increase in chronic heart failure therapy
Time frame: Baseline to a minimum of 24 months
All-cause mortality
All-cause mortality
Time frame: Baseline to a minimum of 24 months
Heart Failure events
Heart failure event defined as an admission to a healthcare facility for \> 24 hours or clinically significant worsening heart failure leading to an intervention (defined as treatment in an emergency department, a same-day access clinic, or an infusion centre) or unscheduled visits to a healthcare provider for administration of an intravenous diuretic as accepted by FDA and an increase in chronic heart failure therapy
Time frame: Baseline to a minimum of 24 months
Health related QoL
Minnesota Living with Heart Failure. Scoring: The higher the score, the worse the HRQL
Time frame: Baseline to a minimum of 24 months
Health related QoL
EuroQol- 5 Dimension. Scoring 0 = worst to 100 = best
Time frame: Baseline to a minimum of 24 months
Health related QoL
Atrial Fibrillation Effect on Quality-of-life. Scoring 0 = worst to 100 = best
Time frame: Baseline to a minimum of 24 months
Exercise capacity
as determined by 6 Minute Hall walk distance
Time frame: Baseline to a minimum of 24 months
NT-proBNP/BNP at 1 year and at 2 year follow-up
NT-proBNP/BNP
Time frame: Baseline to a minimum of 24 months
All-cause mortality and heart failure events in patients with HF, impaired (LVEF≤45%) LV function and high burden AF
Time frame: Baseline to a minimum of 24 months
All-cause mortality and heart failure events in patients with HF, preserved (LVEF > 45%) LV function and high burden AF
Time frame: Baseline to a minimum of 24 months
Health economics
Cost economics
Time frame: Baseline to a minimum of 24 months
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