Back to resultsRhythm 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)
Primary Purpose
Heart Failure, Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Rhythm control
Rate Control
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Atrial Fibrillation, Catheter Ablation, Anti-arrhythmic Medications, Cardiovascular Mortality
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
- 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
Sites / Locations
- Instituto de Cardiologia-FUC RS
- Libin Cardiovascular Institute of Alberta, Calgary
- Royal Alexandra Hospital
- Vancouver General
- Royal Jubilee Hospital
- Queen Elizabeth II Health Science
- Hamilton Health Sciences Centre
- Kingston General Hospital
- St. Mary's General Hospital
- London Health Sciences Centre
- Southlake Regional Health Care
- University of Ottawa Heart Institute
- Sunnybrook Health Sciences Centre
- Toronto General Hospital, University Health Network
- Institute de Cardiologie de Montréal
- CHUM Centre hospitalier universitaire de Montréal
- McGill University Health Centre
- Insitut universitaire de cardiologie and pneumologie de Quebec
- CHUS Centre Hospitalier Universitaire de Sherbrooke
- Karolinska University Hospital
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Rhythm Control
Rate Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Composite of all-cause mortality and heart failure events
Heart failure event defined as an admission to a healthcare facility for > 24 hours or clinically significant worsening heart failure leading to an intervention (defined as treatment in an emergency department, a same-day access clinic, or an infusion centre) or unscheduled visits to a healthcare provider for administration of an intravenous diuretic as accepted by FDA and an increase in chronic heart failure therapy
Secondary Outcome Measures
All-cause mortality
All-cause mortality
Heart Failure events
Heart failure event defined as an admission to a healthcare facility for > 24 hours or clinically significant worsening heart failure leading to an intervention (defined as treatment in an emergency department, a same-day access clinic, or an infusion centre) or unscheduled visits to a healthcare provider for administration of an intravenous diuretic as accepted by FDA and an increase in chronic heart failure therapy
Health related QoL
Minnesota Living with Heart Failure. Scoring: The higher the score, the worse the HRQL
Health related QoL
EuroQol- 5 Dimension. Scoring 0 = worst to 100 = best
Health related QoL
Atrial Fibrillation Effect on Quality-of-life. Scoring 0 = worst to 100 = best
Exercise capacity
as determined by 6 Minute Hall walk distance
NT-proBNP/BNP at 1 year and at 2 year follow-up
NT-proBNP/BNP
All-cause mortality and heart failure events in patients with HF, impaired (LVEF≤45%) LV function and high burden AF
All-cause mortality and heart failure events in patients with HF, preserved (LVEF > 45%) LV function and high burden AF
Health economics
Cost economics
Full Information
NCT ID
NCT01420393
First Posted
August 17, 2011
Last Updated
October 13, 2021
Sponsor
Ottawa Heart Institute Research Corporation
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT01420393
Brief Title
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
Acronym
RAFT-AF
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 Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
May 2021 (Actual)
Study Completion Date
June 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Heart Institute Research Corporation
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 heart failure events defined as an admission to a healthcare facility for > 24 hours or clinically significant worsening heart failure leading to an intervention (defined as treatment in an emergency department, a same-day access clinic, or an infusion centre) or unscheduled visits to a healthcare provider for administration of an intravenous diuretic and an increase in chronic heart failure therapy. 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.
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 Continuous Monitoring at six month intervals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Atrial Fibrillation
Keywords
Heart Failure, Atrial Fibrillation, Catheter Ablation, Anti-arrhythmic Medications, Cardiovascular Mortality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
411 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rhythm Control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Rate Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Rhythm control
Other Intervention Name(s)
Catheter ablation
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Rate Control
Other Intervention Name(s)
Standard medical therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Composite of all-cause mortality and heart failure events
Description
Heart failure event defined as an admission to a healthcare facility for > 24 hours or clinically significant worsening heart failure leading to an intervention (defined as treatment in an emergency department, a same-day access clinic, or an infusion centre) or unscheduled visits to a healthcare provider for administration of an intravenous diuretic as accepted by FDA and an increase in chronic heart failure therapy
Time Frame
Baseline to a minimum of 24 months
Secondary Outcome Measure Information:
Title
All-cause mortality
Description
All-cause mortality
Time Frame
Baseline to a minimum of 24 months
Title
Heart Failure events
Description
Heart failure event defined as an admission to a healthcare facility for > 24 hours or clinically significant worsening heart failure leading to an intervention (defined as treatment in an emergency department, a same-day access clinic, or an infusion centre) or unscheduled visits to a healthcare provider for administration of an intravenous diuretic as accepted by FDA and an increase in chronic heart failure therapy
Time Frame
Baseline to a minimum of 24 months
Title
Health related QoL
Description
Minnesota Living with Heart Failure. Scoring: The higher the score, the worse the HRQL
Time Frame
Baseline to a minimum of 24 months
Title
Health related QoL
Description
EuroQol- 5 Dimension. Scoring 0 = worst to 100 = best
Time Frame
Baseline to a minimum of 24 months
Title
Health related QoL
Description
Atrial Fibrillation Effect on Quality-of-life. Scoring 0 = worst to 100 = best
Time Frame
Baseline to a minimum of 24 months
Title
Exercise capacity
Description
as determined by 6 Minute Hall walk distance
Time Frame
Baseline to a minimum of 24 months
Title
NT-proBNP/BNP at 1 year and at 2 year follow-up
Description
NT-proBNP/BNP
Time Frame
Baseline to a minimum of 24 months
Title
All-cause mortality and heart failure events in patients with HF, impaired (LVEF≤45%) LV function and high burden AF
Time Frame
Baseline to a minimum of 24 months
Title
All-cause mortality and heart failure events in patients with HF, preserved (LVEF > 45%) LV function and high burden AF
Time Frame
Baseline to a minimum of 24 months
Title
Health economics
Description
Cost economics
Time Frame
Baseline to a minimum of 24 months
Other Pre-specified Outcome Measures:
Title
LV function and remodeling (LVESVi) at 1 year and 2 year follow-up
Description
Echocardiogram measure LVESVi
Time Frame
Baseline to a minimum of 24 months
Title
AF Burden at 1 year and 2 year follow-up
Description
14 Day Continuous ECG monitoring
Time Frame
Baseline to a minimum of 24 months
Title
Total number of heart failure events
Description
Heart failure event defined as an admission to a healthcare facility for > 24 hours or clinically significant worsening heart failure leading to an intervention (defined as treatment in an emergency department, a same-day access clinic, or an infusion centre) or unscheduled visits to a healthcare provider for administration of an intravenous diuretic as accepted by FDA and an increase in chronic heart failure therapy
Time Frame
Baseline to a minimum of 24 months
Title
Total number of Cardiovascular hospitalizations
Description
Cardiovascular hospitalizations
Time Frame
Baseline to a minimum of 24 months
Title
Safety (Adverse Events)
Description
Thromboembolic events, symptomatic Pulmonary vein stenosis, atrio-esophageal fistula, pericardial effusion requiring pericardiocentesis, major bleeding requiring blood transfusion, amiodarone induced thyroid, pulmonary and other toxicity
Time Frame
Baseline to a minimum of 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Tang, MD FRCPC
Organizational Affiliation
Western University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
George Wells, PhD
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Cardiologia-FUC RS
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90620-001
Country
Brazil
Facility Name
Libin Cardiovascular Institute of Alberta, Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
Facility Name
Vancouver General
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Royal Jubilee Hospital
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 4R2
Country
Canada
Facility Name
Queen Elizabeth II Health Science
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Hamilton Health Sciences Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
St. Mary's General Hospital
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2M 1B2
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Southlake Regional Health Care
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 8C3
Country
Canada
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Toronto General Hospital, University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Institute de Cardiologie de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
CHUM Centre hospitalier universitaire de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Insitut universitaire de cardiologie and pneumologie de Quebec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
CHUS Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
S-171 76
Country
Sweden
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
35313733
Citation
Parkash R, Wells GA, Rouleau J, Talajic M, Essebag V, Skanes A, Wilton SB, Verma A, Healey JS, Sterns L, Bennett M, Roux JF, Rivard L, Leong-Sit P, Jensen-Urstad M, Jolly U, Philippon F, Sapp JL, Tang ASL. Randomized Ablation-Based Rhythm-Control Versus Rate-Control Trial in Patients With Heart Failure and Atrial Fibrillation: Results from the RAFT-AF trial. Circulation. 2022 Jun 7;145(23):1693-1704. doi: 10.1161/CIRCULATIONAHA.121.057095. Epub 2022 Mar 22.
Results Reference
derived
Learn more about this trial
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
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