CompletedNCT01420393RAFT-AFUpdated May 11, 2026Results posted

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

An interventional study of Rhythm control and Rate Control in Heart Failure and Atrial Fibrillation, sponsored by Ottawa Heart Institute Research Corporation. Completed at 21 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-11.

Sponsored by Ottawa Heart Institute Research Corporation · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 411
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

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 studied

Heart Failure
Atrial Fibrillation

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Keywords

Heart Failure
Atrial Fibrillation
Catheter Ablation
Anti-arrhythmic Medications
Cardiovascular Mortality

In context

Heart Failure

5,703 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 411 is above the median of 72 across 3,737 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Ottawa Heart Institute Research Corporation is the lead sponsor of 179 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 411 participants (actual)

Study arms

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
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

Interventions

ProcedureRhythm 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
Also known as: Catheter ablation
OtherRate 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.
Also known as: Standard medical therapy

What researchers measure

Primary outcomes

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
Time frame: Baseline to study completion, an average of 24 months

Results

Posted May 11, 2026

Participant flow

Participant flow — Overall Study
Milestone	Rhythm Control	Rate Control
Started	214	197
Completed	209	186
Not completed	5	11
Withdrew: Lost to follow-up	3	4
Withdrew: Withdrawal by subject	2	5
Withdrew: Cardiac transplant	0	2

Outcome measures

PrimaryComposite 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

Time frame:: Baseline to study completion, an average of 24 months
Reported as:: Count of participants · Participants

Composite of All-cause Mortality and Heart Failure Events
Participants	Rhythm Control	Rate Control
Composite of All-cause Mortality and Heart Failure Events	50	64

Adverse events

Collected over Baseline to study completion. Non-serious events are listed at a .97% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Rhythm Control	29/214 (13.6%)	88/214 (41.1%)	66/214 (30.8%)
Rate Control	34/197 (17.3%)	73/197 (37.1%)	68/197 (34.5%)

Most frequent serious events

Showing 10 of 12

Most frequent serious events
Event	Rhythm Control	Rate Control
Total HospitalizationsGeneral disorders	88/214	73/197
CV hospitalizatonCardiac disorders	66/214	68/197
Ablation related hospitalizationsCardiac disorders	23/214	1/197
Major bleedGeneral disorders	8/214	0/197
Pericardial EffusionCardiac disorders	6/214	0/197
StrokeGeneral disorders	5/214	5/197
Minor bleedGeneral disorders	5/214	0/197
Device implant relatedCardiac disorders	1/214	4/197
BradycardiaCardiac disorders	0/214	4/197
Amiodarone-induced toxicityGeneral disorders	0/214	1/197

Most frequent other events

Most frequent other events
Event	Rhythm Control	Rate Control
NON CV hospitalizationsGeneral disorders	66/214	68/197

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Rhythm Control	Rate Control	Total
<=18 years	0	0	0
Between 18 and 65 years	79	56	135
>=65 years	135	141	276

Age, Continuous
Age, Continuous(years)	Rhythm Control	Rate Control	Total
Mean	65.9 ± 8.6	67.5 ± 8.0	66.7 ± 8.3

Sex: Female, Male
Sex: Female, Male(Participants)	Rhythm Control	Rate Control	Total
Female	57	49	106
Male	157	148	305

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Rhythm Control	Rate Control	Total
American Indian or Alaska Native	0	0	0
Asian	6	3	9
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	2	0	2
White	204	193	397
More than one race	0	0	0
Unknown or Not Reported	2	1	3

Region of Enrollment
Region of Enrollment(participants)	Rhythm Control	Rate Control	Total
Canada	206	192	398
Sweden	3	3	6
Taiwan	3	0	3
Brazil	2	2	4

6 Minute walk distance
6 Minute walk distance(metres)	Rhythm Control	Rate Control	Total
Mean	344.4 ± 107.1	363.1 ± 101.4	353.75 ± 104.25

NT-proBNP
NT-proBNP(pg/mL)	Rhythm Control	Rate Control	Total
Median	1583 (1041 to 2641)	1689 (1000 to 2743)	1636 (1020 to 2692)

Study locations

21 sites

Instituto de Cardiologia-FUC RS
Porto Alegre, Rio Grande do Sul 90620-001, Brazil
Libin Cardiovascular Institute of Alberta, Calgary
Calgary, Alberta T2N 2T9, Canada
Royal Alexandra Hospital
Edmonton, Alberta T5H 3V9, Canada
Vancouver General
Vancouver, British Columbia V6Z 1Y6, Canada
Royal Jubilee Hospital
Victoria, British Columbia V8R 4R2, Canada
Queen Elizabeth II Health Science
Halifax, Nova Scotia B3H 3A7, Canada
Hamilton Health Sciences Centre
Hamilton, Ontario L8L 2X2, Canada
Kingston General Hospital
Kingston, Ontario K7L 2V7, Canada
St. Mary's General Hospital
Kitchener, Ontario N2M 1B2, Canada
London Health Sciences Centre
London, Ontario N6A 5A5, Canada
Southlake Regional Health Care
Newmarket, Ontario L3Y 8C3, Canada
University of Ottawa Heart Institute
Ottawa, Ontario K1Y 4W7, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario M4N 3M5, Canada
Toronto General Hospital, University Health Network
Toronto, Ontario M5G 2M9, Canada
Institute de Cardiologie de Montréal
Montreal, Quebec H1T 1C8, Canada
CHUM Centre hospitalier universitaire de Montréal
Montreal, Quebec H2L 4M1, Canada
McGill University Health Centre
Montreal, Quebec H3A 1A1, Canada
Insitut universitaire de cardiologie and pneumologie de Quebec
Québec, Quebec G1V 4G5, Canada
CHUS Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec J1H 5N4, Canada
Karolinska University Hospital
Stockholm, S-171 76, Sweden
National Taiwan University Hospital
Taipei, 100, Taiwan

References and documents

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 documents

Protocol and statistical analysis plan · Dec 18, 2020

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01420393
Lead sponsor: Ottawa Heart Institute Research Corporation
Collaborators: Canadian Institutes of Health Research (CIHR)
Responsible party: Sponsor
First posted: Aug 19, 2011
Start date: Sep 2011
Primary completion: May 2021
Completion: Jun 2021
Results posted: May 11, 2026
Last update: May 11, 2026

Study contacts

Anthony Tang, MD FRCPC

principal investigator · Western University

George Wells, PhD

principal investigator · Ottawa Heart Institute Research Corporation

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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