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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)

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ClinicalTrials.gov Identifier: NCT01420393
Recruitment Status : Active, not recruiting
First Posted : August 19, 2011
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

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 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 or disease Intervention/treatment Phase
Heart Failure Atrial Fibrillation Procedure: Rhythm control Other: Rate Control Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 412 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2011
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Rhythm Control
Patients randomized to catheter ablation-based AF rhythm control group will receive optimal Heart Failure therapy and one or more aggressive catheter ablation, which include PV antral ablation and LA substrate ablation with or without adjunctive antiarrhythmic drug.
Procedure: Rhythm control
Patients randomized to catheter ablation-based AF rhythm control group will receive optimal HF therapy and one or more aggressive catheter ablation, which include PV antral ablation and LA substrate ablation with or without adjunctive antiarrhythmic drug
Other Name: Catheter ablation

Active Comparator: Rate Control
Patients in the rate control group will receive optimal Heart Failure therapy and rate control measures to achieve a resting HR < 80 bpm and 6-minute walk HR < 110 bpm.
Other: Rate Control
Patients in the rate control group will receive optimal HF therapy and rate control measures to achieve a resting HR < 80 bpm and 6-minute walk HR < 110 bpm.
Other Name: Standard medical therapy




Primary Outcome Measures :
  1. Composite of all-cause mortality and hospitalization for heart failure defined as an admission to a health care facility for > 24 hours. [ Time Frame: Baseline to 24 months ]

Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: Baseline to 24 months ]
  2. Cardiovascular Mortality [ Time Frame: Baseline to 24 months ]
  3. All-cause hospitalization [ Time Frame: Baseline to 24 months ]
  4. Heart Failure (HF) hospitalization [ Time Frame: Baseline to 24 months ]
  5. Cardiovascular (CV) hospitalization [ Time Frame: Baseline to 24 months ]
  6. Health related QoL (MLWHF, EQ5D, AFEQT, Specific Activity scale [ Time Frame: Baseline to 24 months ]
  7. Health economics [ Time Frame: Baseline to 24 months ]
  8. 6 minute walk (6MW) distance [ Time Frame: Baseline to 24 months ]
  9. CCS-SAF scale [ Time Frame: Baseline to 24 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01420393


Locations
Brazil
Instituto de Cardiologia-FUC RS
Porto Alegre, Rio Grande Do Sul, Brazil, 90620-001
Instituto de Pesquisa e Estudos Medicos de Itajai-IPEMI
Itajai, Santa Catarina, Brazil
Canada, Alberta
Libin Cardiovascular Institute of Alberta, Calgary
Calgary, Alberta, Canada, T2N 2T9
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
Canada, British Columbia
Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3L 3W4
Vancouver General
Vancouver, British Columbia, Canada, V6Z 1Y6
Royal Jubilee Hospital
Victoria, British Columbia, Canada, V8R 4R2
Canada, Nova Scotia
Queen Elizabeth II Health Science
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Hamilton Health Sciences Centre
Hamilton, Ontario, Canada, L8L 2X2
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
St. Mary's General Hospital
Kitchener, Ontario, Canada, N2M 1B2
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Southlake Regional Health Care
Newmarket, Ontario, Canada, L3Y 8C3
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Toronto General Hospital, University Health Network
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Institute de Cardiologie de Montréal
Montreal, Quebec, Canada, H1T 1C8
CHUM Centre hospitalier universitaire de Montréal
Montreal, Quebec, Canada, H2L 4M1
McGill University Health Centre
Montreal, Quebec, Canada, H3A 1A1
Hôpital du Sacré-Cœur de Montréal
Montreal, Quebec, Canada, H4J 1C5
Insitut universitaire de cardiologie and pneumologie de Quebec
Quebec City, Quebec, Canada, G1V 4G5
CHUS Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Sweden
Karolinska University Hospital
Stockholm, Sweden, S-171 76
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Anthony Tang, MD FRCPC Western University
Principal Investigator: George Wells, PhD Ottawa Heart Institute Research Corporation

Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT01420393     History of Changes
Other Study ID Numbers: 231888
First Posted: August 19, 2011    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

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