Heart DiseaseRAFT-PermAFNCT01994252
Resynchronization/Defibrillation for Ambulatory Heart Failure Trial in Patients With Permanent Atrial Fibrillation
A study testing Optimal Medical therapy plus ICD and Optimal Medical therapy plus CRT/ICD in people with Heart Disease and Congestive Heart Failure, run by Ottawa Heart Institute Research Corporation at 15 sites in Canada.
Trial summary
Atrial fibrillation (AF) and heart failure (HF) are two common heart conditions that are encountered with an increase in death and suffering. When both these two conditions occur in a patient, the patient's prognosis is poor with a reduced quality of life and impaired heart function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Disease, Congestive Heart Failure, Atrial Fibrillation
- What is being tested?
- Optimal Medical therapy plus ICD and Optimal Medical therapy plus CRT/ICD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 15 sitesCanada
- Study dates
- 4 Jun 2014to 29 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 NYHA Class II or III HF symptoms (assessment in the last 3 months)
- Permanent AF
- Optimal Medical Therapy for HF of at least 3 months (according to 2009 ACCF/AHA and ESC 2012 recommendations,)
- LVEF ≤ 35% (assessment in the last 6 months)
- Candidacy for an ICD for primary or secondary prevention of sudden cardiac death
- QRS durations ≥ 130 ms when the QRS morphology is LBBB, or QRS durations ≥ 150 ms when the QRS morphology is non-LBBB or Paced QRS
Who cannot join
- In-hospital patients who have acute cardiac or non-cardiac illness that requires intensive care
- Intra-venous inotropic agent in the last 4 days
- Patients with a life expectancy of less than one year from non-cardiac cause.
- Expected to undergo cardiac transplantation within one year (status I)
- Acute coronary syndrome (including MI) < 4 weeks
- Unable or unwilling to provide informed consent
Show all 13Show fewer
- Uncorrected or uncorrectable primary valvular disease
- Restrictive, hypertrophic or reversible form of cardiomyopathy
- Severe primary pulmonary disease such as cor pulmonale
- Tricuspid prosthetic valve
- Patients included in other clinical trial that will affect the objectives of this study
- Coronary revascularization (CABG or PCI) < 3 months
- Patients with an existing ICD or CRT pacemaker
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Canada15 sites
Libin Cardiovascular Institute of Alberta
Calgary, Alberta
Queen Elizabeth II Health Science
Halifax, Nova Scotia
Hamilton Health Sciences
Hamilton, Ontario
Kingston General Hospital
Kingston, Ontario
London Health Sciences Centre
London, Ontario, N6A 5A5
CHUM Centre hospitalier universitaire de Montréal
Montreal, Quebec
McGill Health Science Centre
Montreal, Quebec
Montreal Heart Institute
Montreal, Quebec
University of Ottawa Heart Institute
Ottawa, Ontario, K1W 4W7
Institut universitaire de cardiologie et de pneumologie de Quebec
Québec, Quebec
Le Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec
St. Michael's General Hospital
Toronto, Ontario
Vancouver General Hospital
Vancouver, British Columbia
Victoria Cardiac Arrhythmia Trials
Victoria, British Columbia, V8R 4R2
St. Boniface General Hospital
Winnipeg, Manitoba
About this study
Atrial fibrillation (AF) and heart failure (HF) are two common heart conditions that are encountered with an increase in death and suffering. When both these two conditions occur in a patient, the patient's prognosis is poor with a reduced quality of life and impaired heart function. These patients have enlarged hearts, specifically the left ventricle (major pumping chamber), which impairs the heart's pumping capacity, leading to symptoms such as fatigue, shortness of breath from any type of exertion, and swelling, usually of the feet and ankles.
In these HF patients who are in AF all of the time, who would otherwise be a suitable candidate for an implantable defibrillator to prevent sudden cardiac death, we would like to determine whether adding pacing of both ventricles will reduce heart size (left ventricular end systolic volume index LVESVi) as measured by ultrasound, which can improve its function and help the heart pump more efficiently.
Other studies have shown that adding pacing to both ventricles is of benefit in HF patients with mild to moderate symptoms and have a regular heart rhythm. The Investigators now want to explore if this therapy will benefit those patients with a permanent irregular heart rhythm (AF).
Read the detailed description
Heart failure (HF) is increasing in prevalence and incidence and is the most common reason for hospital admissions of patients over the age of 65. Therapy for HF has evolved over the last two decades. Cardiac resynchronization therapy (CRT) is a therapy that attempts to resynchronize the sequence of ventricular contraction in heart failure (HF) patients with left ventricular (LV) systolic dysfunction and ventricular dyssynchrony. CRT is achieved by stimulating both RV and LV together, synchronized to right atrial excitation to achieve atrio-ventricular synchrony. Clinical trials have demonstrated that CRT reduced heart size, improved survival and reduced HF hospitalization in mild to advanced HF patients. This knowledge translated to a change in practice guidelines and the adoption of CRT into clinical practice benefitting many HF patients CRT is now an important state-of-the-art therapy for HF patients with LV systolic dysfunction, low LVEF, and prolonged QRS duration in sinus rhythm, since the vast majority of the CRT clinical research was performed in patients in sinus rhythm. However, in the ~25% of HF patients with permanent atrial fibrillation (AF), the effectiveness of CRT is not clear. It is therefore timely to address the question of whether the addition of CRT to optimal HF treatment, rate control and an ICD improves cardiac outcomes in individuals with heart failure (HF) and permanent atrial fibrillation (AF). The outcomes will be measured by a hierarchy of all-cause mortality, HF events, Left Ventricular Ejection Fraction (LVEF) and improvement in Quality of Life (QoL) in patients with permanent AF, mild to moderate HF, left ventricular (LV) systolic dysfunction, and prolonged QRS duration, when compared to implantable cardioverter defibrillator (ICD) therapy alone.
Objectives: To determine whether cardiac resynchronization therapy will improve cardiac outcomes for heart failure patients with permanent atrial fibrillation, mild to moderate heart failure, left ventricular systolic dysfunction, and prolonged QRS duration, when compared to implantable cardioverter defibrillator (ICD) therapy alone.
Methods: This is a multi-centre randomized controlled trial of two treatment groups. The patients, primary physicians and the heart failure caregivers will be blinded to the treatment allocation. The device follow-up caregivers will not be blinded. Patients with NYHA Class II and III HF symptoms, LVEF HF ≤ 35%, permanent AF, on optimal medical therapy and QRS durations ≥ 130 ms when the QRS morphology is LBBB, or QRS durations ≥ 150 ms when the QRS morphology is non-LBBB, or Paced QRS will be included in the trial. Patients should be suitable candidates for either of the 2 treatment strategies. There will be 200 patients randomized in 1:1 ratio to two groups: 1) ICD-CRT, 2) ICD only. All patients will undergo baseline clinical evaluation, echocardiogram measurements, quality of life assessment, medication assessment, and 6-minute walk distance.. The patients will be followed at 1 month, 3 months, 6 months and then every 6 months.
- Conditions
- Heart Disease, Congestive Heart Failure, Atrial Fibrillation
- Being tested
- Optimal Medical therapy plus ICD, Optimal Medical therapy plus CRT/ICD
- Keywords
- defibrillator, cardiac resynchronization
- Medical subject headings
- Heart Diseases, Heart Failure, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimal Medical therapy plus ICDDevice
Optimal Medical therapy plus CRT/ICDDevice
| Study group | Role | What they receive |
|---|---|---|
| Optimal Medical therapy plus ICD | Active comparator | Patients randomized to the (ICD) Implantable-Defibrillator-Cardioverter only group will receive an ICD + optimal medical therapy Receives: Device: Optimal Medical therapy plus ICD |
| Optimal Medical therapy plus CRT/ICD | Active comparator | Patients randomized to the (ICD) Implantable-Defibrillator-Cardioverter plus cardiac resynchronisation therapy (CRT) group will receive an ICD + CRT and optimal medical therapy Receives: Device: Optimal Medical therapy plus CRT/ICD |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is a hierarchy (winratio) of 1) all-cause mortality
Mortality data will be collected for the duration of the study
Measured: 12 months
The primary outcome is a hierarchy (winratio) of 2) Heart Failure Events (>24 Hours admission for Heart Failure or clinically worsening Heart Failure leading to IV diuretics administered
HF events (> 24 hour admit or < 24 hr with IV diuretics) will be collected for the duration of the study
Measured: 12 months
The primary outcome is a hierarchy (winratio) of 3) Left ventricular ejection fraction
Change in echocardiogram parameters LVEF measure
Measured: baseline to 12 months
The primary outcome is a hierarchy (winratio) of 4) QoL - Minnesota Living with Heart Failure Questionnaire
Change in QoL MLHFQ. The MLHFQ score is used to measure quality of life. The MLHFQ consists of 21 questions answered on a 0-5 likert scale, with higher scores indicating a stronger impact of heart failure on QoL.
Measured: baseline to 12 months
Secondary outcomes (10)
All-cause mortality
Death all cause
Measured: Baseline to a minimum of 12 months
Heart Failure Events
Admission to Hospital > 24 hrs for Heart Failure or <24 hrs with clinical worsending of HF leading to intervention
Measured: Baseline to a minimum of 12 months
Changes in LVEF
Left Ventricular ejection fraction
Measured: Baseline to 12 months
Quality of Life Questionnaire
Minnesota Living with Heart Failure
Measured: Baseline to a minimum of 12 months
Composite of all-cause mortality and heart failure
All cause death and admission to to Hospital > 24 hours for Heart Failure
Measured: Baseline to a minimum of 12 months
6 Minute walk distance
Hall walk distance over 6 minute timeframe
Measured: Baseline to a minimum of 12 months
Cardiovascular mortality
Cardiovascular Death
Measured: Baseline to a minimum of 12 months
Cost-effectiveness
Readmission for Heart Failure
Measured: Baseline to a minimum of 12 months
Cardiovascular hospitalizations
Cardiovascular Admission to Hospital > 24 hours
Measured: Baseline to a minimum of 12 months
Quality of Life Questionnaire
EQ5D-5L
Measured: Baseline to a minimum of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study start4 Jun 2014
- Primary completion31 Jan 2024
- Study completion29 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart DiseaseStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
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 SL Tang, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994252
- Sponsor's protocol ID
- RN00208414
- Acronym
- RAFT-PermAF
- Status last verified
- Apr 2026
- First submitted
- 8 Nov 2013
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tang AS, Wells GA, Talajic M, Arnold MO, Sheldon R, Connolly S, Hohnloser SH, Nichol G, Birnie DH, Sapp JL, Yee R, Healey JS, Rouleau JL; Resynchronization-Defibrillation for Ambulatory Heart Failure Trial Investigators. Cardiac-resynchronization therapy for mild-to-moderate heart failure. N Engl J Med. 2010 Dec 16;363(25):2385-95. doi: 10.1056/NEJMoa1009540. Epub 2010 Nov 14.
PubMed 21073365
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resynchronization/Defibrillation for Ambulatory Heart Failure Trial in Patients With Permanent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01994252
- Acronym / sponsor ID
- RAFT-PermAF / RN00208414
- Conditions
- Heart Disease, Congestive Heart Failure, Atrial Fibrillation
- Keywords
- defibrillator, cardiac resynchronization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 4 Jun 2014 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 29 May 2025 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atrial fibrillation (AF) and heart failure (HF) are two common heart conditions that are encountered with an increase in death and suffering. When both these two conditions occur in a patient, the patient's prognosis is poor with a reduced quality of life and impaired heart function. These patients have enlarged hearts, specifically the left ventricle (major pumping chamber), which impairs the heart's pumping capacity, leading to symptoms such as fatigue, shortness of breath from any type of exertion, and swelling, usually of the feet and ankles.
In these HF patients who are in AF all of the time, who would otherwise be a suitable candidate for an implantable defibrillator to prevent sudden cardiac death, we would like to determine whether adding pacing of both ventricles will reduce heart size (left ventricular end systolic volume index LVESVi) as measured by ultrasound, which can improve its function and help the heart pump more efficiently.
Other studies have shown that adding pacing to both ventricles is of benefit in HF patients with mild to moderate symptoms and have a regular heart rhythm. The Investigators now want to explore if this therapy will benefit those patients with a permanent irregular heart rhythm (AF).
Detailed description
Heart failure (HF) is increasing in prevalence and incidence and is the most common reason for hospital admissions of patients over the age of 65. Therapy for HF has evolved over the last two decades. Cardiac resynchronization therapy (CRT) is a therapy that attempts to resynchronize the sequence of ventricular contraction in heart failure (HF) patients with left ventricular (LV) systolic dysfunction and ventricular dyssynchrony. CRT is achieved by stimulating both RV and LV together, synchronized to right atrial excitation to achieve atrio-ventricular synchrony. Clinical trials have demonstrated that CRT reduced heart size, improved survival and reduced HF hospitalization in mild to advanced HF patients. This knowledge translated to a change in practice guidelines and the adoption of CRT into clinical practice benefitting many HF patients CRT is now an important state-of-the-art therapy for HF patients with LV systolic dysfunction, low LVEF, and prolonged QRS duration in sinus rhythm, since the vast majority of the CRT clinical research was performed in patients in sinus rhythm. However, in the ~25% of HF patients with permanent atrial fibrillation (AF), the effectiveness of CRT is not clear. It is therefore timely to address the question of whether the addition of CRT to optimal HF treatment, rate control and an ICD improves cardiac outcomes in individuals with heart failure (HF) and permanent atrial fibrillation (AF). The outcomes will be measured by a hierarchy of all-cause mortality, HF events, Left Ventricular Ejection Fraction (LVEF) and improvement in Quality of Life (QoL) in patients with permanent AF, mild to moderate HF, left ventricular (LV) systolic dysfunction, and prolonged QRS duration, when compared to implantable cardioverter defibrillator (ICD) therapy alone.
Objectives: To determine whether cardiac resynchronization therapy will improve cardiac outcomes for heart failure patients with permanent atrial fibrillation, mild to moderate heart failure, left ventricular systolic dysfunction, and prolonged QRS duration, when compared to implantable cardioverter defibrillator (ICD) therapy alone.
Methods: This is a multi-centre randomized controlled trial of two treatment groups. The patients, primary physicians and the heart failure caregivers will be blinded to the treatment allocation. The device follow-up caregivers will not be blinded. Patients with NYHA Class II and III HF symptoms, LVEF HF ≤ 35%, permanent AF, on optimal medical therapy and QRS durations ≥ 130 ms when the QRS morphology is LBBB, or QRS durations ≥ 150 ms when the QRS morphology is non-LBBB, or Paced QRS will be included in the trial. Patients should be suitable candidates for either of the 2 treatment strategies. There will be 200 patients randomized in 1:1 ratio to two groups: 1) ICD-CRT, 2) ICD only. All patients will undergo baseline clinical evaluation, echocardiogram measurements, quality of life assessment, medication assessment, and 6-minute walk distance.. The patients will be followed at 1 month, 3 months, 6 months and then every 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimal Medical therapy plus ICD | Active comparator | Device: Optimal Medical therapy plus ICDPatients randomized to the (ICD) Implantable-Defibrillator-Cardioverter only group will receive an ICD + optimal medical therapy |
| Optimal Medical therapy plus CRT/ICD | Active comparator | Device: Optimal Medical therapy plus CRT/ICDPatients randomized to the (ICD) Implantable-Defibrillator-Cardioverter plus cardiac resynchronisation therapy (CRT) group will receive an ICD + CRT and optimal medical therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with NYHA Class II or III HF symptoms (assessment in the last 3 months)
- Permanent AF
- Optimal Medical Therapy for HF of at least 3 months (according to 2009 ACCF/AHA and ESC 2012 recommendations,)
- LVEF ≤ 35% (assessment in the last 6 months)
- Candidacy for an ICD for primary or secondary prevention of sudden cardiac death
Key exclusion criteria (13 listed)
- In-hospital patients who have acute cardiac or non-cardiac illness that requires intensive care
- Intra-venous inotropic agent in the last 4 days
- Patients with a life expectancy of less than one year from non-cardiac cause.
- Expected to undergo cardiac transplantation within one year (status I)
- Acute coronary syndrome (including MI) < 4 weeks
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 |
|---|---|---|
| Optimal Medical therapy plus ICD | Device | Optimal Medical therapy plus ICD |
| Optimal Medical therapy plus CRT/ICD | Device | Optimal Medical therapy plus CRT/ICD |
Primary outcome
The primary outcome is a hierarchy (winratio) of 1) all-cause mortality
Time frame: 12 months
Mortality data will be collected for the duration of the study
The primary outcome is a hierarchy (winratio) of 2) Heart Failure Events (>24 Hours admission for Heart Failure or clinically worsening Heart Failure leading to IV diuretics administered
Time frame: 12 months
HF events (> 24 hour admit or < 24 hr with IV diuretics) will be collected for the duration of the study
The primary outcome is a hierarchy (winratio) of 3) Left ventricular ejection fraction
Time frame: baseline to 12 months
Change in echocardiogram parameters LVEF measure
The primary outcome is a hierarchy (winratio) of 4) QoL - Minnesota Living with Heart Failure Questionnaire
Time frame: baseline to 12 months
Change in QoL MLHFQ. The MLHFQ score is used to measure quality of life. The MLHFQ consists of 21 questions answered on a 0-5 likert scale, with higher scores indicating a stronger impact of heart failure on QoL.
10 secondary outcomes
All-cause mortality
Time frame: Baseline to a minimum of 12 months
Heart Failure Events
Time frame: Baseline to a minimum of 12 months
Changes in LVEF
Time frame: Baseline to 12 months
Quality of Life Questionnaire
Time frame: Baseline to a minimum of 12 months
Composite of all-cause mortality and heart failure
Time frame: Baseline to a minimum of 12 months
6 Minute walk distance
Time frame: Baseline to a minimum of 12 months
Cardiovascular mortality
Time frame: Baseline to a minimum of 12 months
Cost-effectiveness
Time frame: Baseline to a minimum of 12 months
Cardiovascular hospitalizations
Time frame: Baseline to a minimum of 12 months
Quality of Life Questionnaire
Time frame: Baseline to a minimum of 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Background: PubMed 21073365Tang AS, Wells GA, Talajic M, Arnold MO, Sheldon R, Connolly S, Hohnloser SH, Nichol G, Birnie DH, Sapp JL, Yee R, Healey JS, Rouleau JL; Resynchronization-Defibrillation for Ambulatory Heart Failure Trial Investigators. Cardiac-resynchronization therapy for mild-to-moderate heart failure. N Engl J Med. 2010 Dec 16;363(25):2385-95. doi: 10.1056/NEJMoa1009540. Epub 2010 Nov 14.
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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 SL Tang, MD principal investigator
Ottawa Heart Institute Research Corporation
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimal Medical therapy plus ICD and Optimal Medical therapy plus CRT/ICD in people with Heart Disease and Congestive Heart Failure, run by Ottawa Heart Institute Research Corporation at 15 sites in Canada.
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 6 inclusion and 13 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 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcome is a hierarchy (winratio) of 1) all-cause mortality (time frame: 12 months). The study lists 4 primary outcomes in all. 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 NCT01994252, 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 30 Apr 2026.