Status:
COMPLETED
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
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Heart Failure
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
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 pr...
Detailed Description
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 Continuou...
Eligibility Criteria
Inclusion
- 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
- Optimal therapy for heart failure of at least 6 weeks (according to 2009 ACCF/AHA class 1 recommendations).
- 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
- 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
- Suitable candidate for catheter ablation or rate control therapy for the treatment of AF
- Age ≥18
Exclusion
- Have an LA dimension \> 55 mm as determined by an echocardiography within the previous year
- Had an acute coronary syndrome or coronary artery bypass surgery within 12 weeks
- Have rheumatic heart disease, severe aortic or mitral valvular heart disease using the AHA/ACC guidelines
- Have congenital heart disease including previous ASD repair, persistent left superior vena cava
- Had prior surgical or percutaneous AF ablation procedure or atrioventricular nodal (AVN) ablation
- Have a medical condition likely to limit survival to \< 1 year
- Have New York Heart Association (NYHA) class IV heart failure symptoms
- Have contraindication to systematic anticoagulation
- Have renal failure requiring dialysis
- AF due to reversible cause e.g. hyperthyroid state
- Are pregnant
- Are included in other clinical trials that will affect the objectives of this study
- Have a history of non-compliance to medical therapy
- Are unable or unwilling to provide informed consent
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
411 Patients enrolled
Trial Details
Trial ID
NCT01420393
Start Date
September 1 2011
End Date
June 1 2021
Last Update
October 21 2021
Active Locations (21)
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1
Instituto de Cardiologia-FUC RS
Porto Alegre, Rio Grande do Sul, Brazil, 90620-001
2
Libin Cardiovascular Institute of Alberta, Calgary
Calgary, Alberta, Canada, T2N 2T9
3
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
4
Vancouver General
Vancouver, British Columbia, Canada, V6Z 1Y6