Rhythm Control - Catheter Ablation With or Without Anti-arrhythmic Drug Control of Maintaining Sinus Rhythm Versus Rate Control With Medical Therapy and/or Atrio-ventricular Junction Ablation and Pacemaker Treatment for Atrial Fibrillation

Launched by OTTAWA HEART INSTITUTE RESEARCH CORPORATION · Aug 18, 2011

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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