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 (RAFT-AF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Ottawa Heart Institute Research Corporation
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier:
NCT01420393
First received: August 17, 2011
Last updated: July 2, 2014
Last verified: July 2014

August 17, 2011
July 2, 2014
September 2011
September 2016   (final data collection date for primary outcome measure)
Composite of all-cause mortality and hospitalization for heart failure defined as an admission to a health care facility for > 24 hours. [ Time Frame: Five year study ] [ Designated as safety issue: Yes ]
Cardiovascular mortality [ Time Frame: Five year study ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01420393 on ClinicalTrials.gov Archive Site
All-cause mortality, Cardiovascular Mortality, All-cause hospitalization, Heart Failure hospitalization, CV hospitalization, health related QoL, see description for more details [ Time Frame: Five year study ] [ Designated as safety issue: Yes ]
Health related QoL, Atrial Fibrillation burden, 6 minute walk distance, Left Ventricular Ejection Fraction, CCS-SAF scale
Not Provided
Not Provided
Not Provided
 
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
A Randomized Ablation-based Atrial Fibrillation Rhythm Control Versus Rate Control Trial in Patients With Heart Failure and High Burden Atrial Fibrillation

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 hospitalization for heart failure defined as an admission to a health care facility for > 24 hours. The investigators will also be assessing the cost-effectiveness of this treatment strategy and the life quality for these patients. 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Heart Failure
  • Atrial Fibrillation
  • Procedure: Catheter ablation-based AF rhythm control
    Catheter Ablation Atrial Fibrillation
    Other Name: Catheter ablation
  • Drug: Medication Rate Control
    Rate control medication
    Other Name: Standard medical therapy
  • Active Comparator: Rhythm Control
    Catheter ablation with or without anti-arrhythmic drug control of maintaining sinus rhythm
    Intervention: Procedure: Catheter ablation-based AF rhythm control
  • Active Comparator: Rate Control
    Medical therapy and/or atrio-ventricular junction ablation and pacemaker treatment for atrial fibrillation
    Intervention: Drug: Medication Rate Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
September 2016
September 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Anthony Tang, MD anthonysltang@gmail.com
Canada
 
NCT01420393
231888
Yes
Ottawa Heart Institute Research Corporation
Ottawa Heart Institute Research Corporation
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Anthony Tang, MD Ottawa Heart Institute Research Corporation
Principal Investigator: George Wells, PhD Ottawa Heart Institute Research Corporation
Ottawa Heart Institute Research Corporation
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP