Heart FailureRAFT-AFNCT01420393
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 study of Heart Failure and Atrial Fibrillation, run by Ottawa Heart Institute Research Corporation at 21 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Atrial Fibrillation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 411 participants
- Where
- 21 sitesin 4 countries
- Study dates
- Sep 2011to Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 18Show fewer
- 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:
- 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
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
21 sites in 4 countries.
21 sites in 4 countries
Canada18 sites
Libin Cardiovascular Institute of Alberta, Calgary
Calgary, Alberta, T2N 2T9
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
Queen Elizabeth II Health Science
Halifax, Nova Scotia, B3H 3A7
Hamilton Health Sciences Centre
Hamilton, Ontario, L8L 2X2
Kingston General Hospital
Kingston, Ontario, K7L 2V7
St. Mary's General Hospital
Kitchener, Ontario, N2M 1B2
London Health Sciences Centre
London, Ontario, N6A 5A5
Institute de Cardiologie de Montréal
Montreal, Quebec, H1T 1C8
CHUM Centre hospitalier universitaire de Montréal
Montreal, Quebec, H2L 4M1
McGill University Health Centre
Montreal, Quebec, H3A 1A1
Southlake Regional Health Care
Newmarket, Ontario, L3Y 8C3
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Insitut universitaire de cardiologie and pneumologie de Quebec
Québec, Quebec, G1V 4G5
CHUS Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Toronto General Hospital, University Health Network
Toronto, Ontario, M5G 2M9
Vancouver General
Vancouver, British Columbia, V6Z 1Y6
Royal Jubilee Hospital
Victoria, British Columbia, V8R 4R2
Brazil1 site
Instituto de Cardiologia-FUC RS
Porto Alegre, Rio Grande do Sul, 90620-001
About this study
Official title: 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 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.
Read the 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.
Updated June 2024:
Additional analysis will be completed using the winratio analysis for the hierarchical primary outcome of:
- All-cause mortality (time to event)
- Heart Failure Events (number of events per year) 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
- Minnesota Living with Heart Failure Questionnaire (change from baseline to 12-month)
- Six Minute Hall Walk Test (change from baseline to 12-month)
- Conditions
- Heart Failure, Atrial Fibrillation
- Being tested
- Rhythm control, Rate Control
- Keywords
- Heart Failure, Atrial Fibrillation, Catheter Ablation, Anti-arrhythmic Medications, Cardiovascular Mortality
- Medical subject headings
- Heart Failure, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythm controlProcedure or surgery
Also called Catheter ablation
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
Rate ControlOther
Also called Standard medical therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Rhythm Control | Active comparator | 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. Receives: Procedure: Rhythm control |
| Rate Control | Active comparator | 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. Receives: Other: Rate Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to study completion, an average of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionMay 2021
- Study completionJun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Anthony Tang, MD FRCPC, Principal investigator, Western UniversityGeorge Wells, PhD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420393
- Sponsor's protocol ID
- 231888
- Acronym
- RAFT-AF
- Status last verified
- Jul 2024
- First submitted
- 17 Aug 2011
- Last updated
- 11 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 35313733
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Ablation-based Atrial Fibrillation Rhythm Control Versus Rate Control Trial in Patients With Heart Failure and High Burden Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01420393
- Acronym / sponsor ID
- RAFT-AF / 231888
- Conditions
- Heart Failure, Atrial Fibrillation
- Keywords
- Heart Failure, Atrial Fibrillation, Catheter Ablation, Anti-arrhythmic Medications, Cardiovascular Mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 411 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Sep 2011
- Primary completion
- May 2021 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 19 Aug 2011 (estimated)
- Results
- Posted 11 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Updated June 2024:
Additional analysis will be completed using the winratio analysis for the hierarchical primary outcome of:
- All-cause mortality (time to event)
- Heart Failure Events (number of events per year) 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
- Minnesota Living with Heart Failure Questionnaire (change from baseline to 12-month)
- Six Minute Hall Walk Test (change from baseline to 12-month)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rhythm Control | Active comparator | Procedure: Rhythm controlPatients 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. |
| Rate Control | Active comparator | Other: Rate ControlPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients with one of the following AF categories and at least one ECG documentation of AF
- 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:
- i- Is presently in Normal Sinus Rhythm and NT-pro BNP is ≥ 400 pg/mL
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhythm controlAlso: Catheter ablationPatients 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 | Procedure or surgery | Rhythm Control |
| Rate ControlAlso: Standard medical therapyPatients 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 | Rate Control |
Primary outcome
Composite of All-cause Mortality and Heart Failure Events
Time frame: Baseline to study completion, an average of 24 months
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35313733Parkash 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Tang, MD FRCPC principal investigator
Western University
George Wells, PhD principal investigator
Ottawa Heart Institute Research Corporation
21 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Heart Failure and Atrial Fibrillation, run by Ottawa Heart Institute Research Corporation at 21 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Canada, Brazil, Sweden, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of All-cause Mortality and Heart Failure Events (time frame: Baseline to study completion, an average of 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01420393, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.