Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Ablation-based Atrial Fibrillation Rhythm Control Versus Rate Control Trial in Patients With Heart Failure and High Burden Atrial Fibrillation
Brief Summary: 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.


Options:
A: Inclusion Criteria:

1. Patients with one of the following AF categories and at least one ECG documentation of AF

   * High burden Paroxysmal defined as ≥ 4 episodes of AF in the last 6 months, and at least one episode \> 6 hours (and no episode requiring cardioversion and no episode \> 7 days)
   * Persistent AF (1) defined as ≥ 4 episodes of AF in the last 6 months, and at least one episode \> 6 hours, and at least one AF episode less than 7 days but requires cardioversion. No AF episodes are \> 7 days
   * Persistent AF (2) as defined by at least one episode of AF \> 7 days but not \> 1 year
   * Long term persistent AF defined as an AF episode, at least one year in length and no episodes \> 3 years
2. Optimal therapy for heart failure of at least 6 weeks (according to 2009 ACCF/AHA class 1 recommendations).
3. HF with NYHA class II or III symptoms with either impaired LV function (LVEF ≤ 45%) as determined by EF assessment within the previous 12 months or preserved LV function (LVEF \> 45%) determined by by EF assessment within the previous 12 months
4. NT-pro BNP measures:

   A) Patient has been hospitalized for Heart Failure\* in the past 9 months, has been discharged AND:

   i- Is presently in Normal Sinus Rhythm and NT-pro BNP is ≥ 400 pg/mL

   ii- Is presently in Atrial Fibrillation and NT-pro BNP is ≥ 600 pg/mL

   OR

   B) Patient has had no hospitalization for Heart Failure in the past 9 months AND:

   i- Has had paroxysmal Atrial Fibrillation, is presently in Normal Sinus Rhythm and NT-proBNP is ≥ 600 pg/mL

   ii- Is presently in Atrial Fibrillation and NT-proBNP is ≥ 900 pg/mL

   \*Heart Failure Admission is defined as admission to hospital \> 24 hours and received treatment for Heart failure
5. Suitable candidate for catheter ablation or rate control therapy for the treatment of AF
6. Age ≥18

Exclusion Criteria:

1. Have an LA dimension \> 55 mm as determined by an echocardiography within the previous year
2. Had an acute coronary syndrome or coronary artery bypass surgery within 12 weeks
3. Have rheumatic heart disease, severe aortic or mitral valvular heart disease using the AHA/ACC guidelines
4. Have congenital heart disease including previous ASD repair, persistent left superior vena cava
5. Had prior surgical or percutaneous AF ablation procedure or atrioventricular nodal (AVN) ablation
6. Have a medical condition likely to limit survival to \< 1 year
7. Have New York Heart Association (NYHA) class IV heart failure symptoms
8. Have contraindication to systematic anticoagulation
9. Have renal failure requiring dialysis
10. AF due to reversible cause e.g. hyperthyroid state
11. Are pregnant
12. Are included in other clinical trials that will affect the objectives of this study
13. Have a history of non-compliance to medical therapy
14. Are unable or unwilling to provide informed consent
B: Inclusion Criteria:

* Patients age is18 years or greater;
* Patients undergoing a first-time ablation procedure for AF;
* Patients with persistent AF;
* Persistent AF will be defined as a sustained episode lasting \> 7 days and less than 3 years.
* Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication;
* At least one episode of persistent AF must have been documented by ECG, holter, loop recorder, telemetry, trans telephonic monitoring (TTM), or implantable device within last 2 years of enrollment in this investigation;
* Patients must be able and willing to provide written informed consent to participate in this investigation; and
* Patients must be willing and able to comply with all peri-ablation and follow-up requirements.

Exclusion Criteria:

* Patients with paroxysmal AF;
* Patients with long-standing persistent AF;
* Patients for whom cardioversion or sinus rhythm will never be attempted/pursued;
* Patients with AF felt to be secondary to an obvious reversible cause;
* Patients with contraindications to systemic anticoagulation with heparin or coumadin or a direct thrombin inhibitor;
* Patients with left atrial size ≥ 60 mm (2D echocardiography, parasternal long axis view); and
* Patients who are pregnant.
C: Inclusion Criteria:

* 18 years of age or older
* Paroxysmal atrial fibrillation for at least 6 months with at least 2 symptomatic episodes (patient history) during the previous month
* Atrial fibrillation (patient history or echocardiogram documented) resistant to at least one antiarrhythmic drug of Class I or III
* Documentation of at least one episode of atrial fibrillation on 12-lead echocardiogram or Holter Monitor

Exclusion Criteria:

* Contraindications to more than 2 antiarrhythmic drugs of different classes, or to oral anticoagulants
* History of any previous ablation for atrial fibrillation
* Intracardiac thrombus
* Atrial fibrillation due to reversible cause
* Pregnancy
* Contraindication to stopping oral anticoagulation (for example as a result of a mechanical cardiac valve)
D: Inclusion Criteria:

* Informed consent
* Persistent atrial fibrillation (AF)
* New York Heart Association (NYHA) II, III and IV chronic heart failure (CHF) despite optimal medical therapy for at least 3 months
* left ventricular ejection fraction (LVEF) \<35% - as measured by radionuclide ventriculography (RNVG)
* Patients with CHF secondary to ischaemic and non-ischaemic aetiology

Exclusion Criteria:

* QRS duration \>150ms (or QRS 120-150 with evidence of mechanical cardiac dysynchrony)
* Magnetic resonance imaging (MRI) - incompatible metallic (ferrous) prosthesis
* Primary valvular disease as a cause of CHF
* Reversible causes of CHF
* Acute myocarditis
* Patients aged 18 or less
* Patients having undergone revascularisation procedures within 6 months
* Paroxysmal AF
* Pregnancy
* Expected cardiac transplantation within 6 months

Answer: A