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
  Purpose

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.


Condition Intervention
Heart Failure
Atrial Fibrillation
Procedure: Catheter ablation-based AF rhythm control
Drug: Medication Rate Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Ablation-based Atrial Fibrillation Rhythm Control Versus Rate Control Trial in Patients With Heart Failure and High Burden Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Ottawa Heart Institute Research Corporation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 1000
Study Start Date: September 2011
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rhythm Control
Catheter ablation with or without anti-arrhythmic drug control of maintaining sinus rhythm
Procedure: Catheter ablation-based AF rhythm control
Catheter Ablation Atrial Fibrillation
Other Name: Catheter ablation
Active Comparator: Rate Control
Medical therapy and/or atrio-ventricular junction ablation and pacemaker treatment for atrial fibrillation
Drug: Medication Rate Control
Rate control medication
Other Name: Standard medical therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420393

Contacts
Contact: Anthony Tang, MD anthonysltang@gmail.com

Locations
Canada, Alberta
Libin Cardiovascular Institute of Alberta, Calgary Recruiting
Calgary, Alberta, Canada, T2N 2T9
Principal Investigator: Stephen Wilton, MD         
Royal Alexandra Hospital Active, not recruiting
Edmonton, Alberta, Canada, T5H 3V9
Canada, British Columbia
Vancouver General Active, not recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Royal Jubilee Hospital Recruiting
Victoria, British Columbia, Canada, V8R 4R2
Principal Investigator: Laurence Sterns, MD         
Canada, Nova Scotia
Queen Elizabeth II Health Science Recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Principal Investigator: Ratika Parkash, MD         
Canada, Ontario
Hamilton Health Sciences Centre Active, not recruiting
Hamilton, Ontario, Canada, L8L 2X2
Kingston General Hospital Active, not recruiting
Kingston, Ontario, Canada, K7L 2V7
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5A5
Principal Investigator: Alan Skanes, MD         
Southlake Regional Health Care Recruiting
Newmarket, Ontario, Canada, L3Y 8C3
Principal Investigator: Atul Verma, MD         
University of Ottawa Heart Institute Active, not recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Sunnybrook Health Sciences Centre Active, not recruiting
Toronto, Ontario, Canada, M4N 3M5
Toronto General Hospital, University Health Network Not yet recruiting
Toronto, Ontario, Canada, M5G 2M9
Principal Investigator: Andrew Ha, MD         
Canada, Quebec
CHUM Centre hospitalier universitaire de Montréal Recruiting
Montreal, Quebec, Canada, H2L 4M1
Principal Investigator: Isabelle Greiss, MD         
Hôpital du Sacré-Cœur de Montréal Active, not recruiting
Montreal, Quebec, Canada, H4J 1C5
McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H3A 1A1
Principal Investigator: Vidal Essebag, MD         
Institute de Cardiologie de Montréal Active, not recruiting
Montreal, Quebec, Canada, H1T 1C8
Insitut universitaire de cardiologie and pneumologie de Quebec Recruiting
Quebec City, Quebec, Canada, G1V 4G5
Principal Investigator: Isabelle Nault, MD         
CHUS Centre Hospitalier Universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Principal Investigator: Jean-Francois Roux, MD         
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Anthony Tang, MD Ottawa Heart Institute Research Corporation
Principal Investigator: George Wells, PhD Ottawa Heart Institute Research Corporation
  More Information

No publications provided

Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT01420393     History of Changes
Other Study ID Numbers: 231888
Study First Received: August 17, 2011
Last Updated: July 2, 2014
Health Authority: Canada: Health Canada

Keywords provided by Ottawa Heart Institute Research Corporation:
Heart Failure
Atrial Fibrillation
Catheter Ablation
Anti-arrhythmic Medications
Cardiovascular Mortality

Additional relevant MeSH terms:
Heart Failure
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014