Atrial FibrillationRAFT-P&A RCTNCT06299514
RAFT - Pace &Ablate
A study testing Pace and Ablate and Medication in people with Atrial Fibrillation and Heart Failure, run by Habib Khan at 12 sites in Canada.
Trial summary
Atrial fibrillation (AF) is an irregular heartbeat that can cause symptoms of skipped beats, shortness of breath, stroke, or in some cases fluid in the lungs or legs. Treating AF is mostly to do with slowing the heart rate down so that the heart can get a chance to regain some energy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Heart Failure, Pacemaker
- What is being tested?
- Pace and Ablate and Medication
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 12 sitesCanada
- Study dates
- 25 Apr 2024to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 permanent AF/persistent AF (in AF)
- Patients with NYHA Class II -IVa HF symptoms
- Guideline driven medical therapy (GDMT) for HF for at least 3 months:
- for those < 75 years of age with an NT-proBNP of ≥ 600 ng/L
- for those ≥ 75 years of age with an NT-proBNP ≥ 900 ng/L, or ≥ 600 ng/L if the patient has had a HF hospitalization within 1 year
Who cannot join
- In hospital patients needing intensive care or intravenous inotropic agent in the last 4 days
- Patients with a life expectancy of ≤ 1 year from non-cardiac cause or anticipating a transplant within 1 year
- Acute coronary syndrome <4 weeks or coronary revascularization <3months
- Unable or unwilling to provide informed consent
- Uncorrected primary valvular disease or prosthetic tricuspid valve
- Restrictive, hypertrophic, or irreversible form of cardiomyopathy
Show all 14Show fewer
- Severe pulmonary diseases requiring oxygenation
- Patients with a known history of WHO Class I pulmonary hypertension (PH) which includes PH associated with CVD, collagen vascular disease, congenital shunts, cirrhosis and portal hypertension, HIV, hemoglobinopathies, schistosomiasis or drug-associated PH as well as those with high suspicion of irreversible pulmonary hypertension
- Patients enrolled in competitive clinical trials that will affect the objectives of this study
- Existing CRT/BiVP
- Patients who are pregnant
- Guideline indication for CRT
- More than 20% pacing with an existing pacemaker
- Severe mobility limitations (ex. wheelchair bound and severe neurological conditions that limit mobility)
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Canada12 sites, 12 recruiting
- Recruiting
Nova Scotia Health Authority
Halifax, Nova Scotia, B3S0H6
Ratika Parkash, MD
- Recruiting
Hamilton Health Sciences Corporation
Hamilton, Ontario, L8L2X2
Jeff Healey, MD
- Recruiting
Waterloo Wellington Cardiovascular Research Institute
Kitchener, Ontario, N2G1G3
Umjeet Jolly, MD
- Recruiting
London Health Sciences Centre - University Hospital
London, Ontario, N6A5A5
Dr. Habib Khan, 519-663-3746, habib.khan@lhsc.on.ca
- Recruiting
Centre Hospitalier de L'Université de Montréal (CHUM)
Montreal, Quebec, H2X0A9
Isabelle Greiss, MD
- Recruiting
Montreal Heart Institute
Montreal, Quebec
Alexandre Raymond-Paquin, MD
- Recruiting
Southlake Regional Health Centre
Newmarket, Ontario
Bernice Tsang, MD
- Recruiting
Ottawa Heart Institute Research Corporation
Ottawa, Ontario, K1Y4W7
Callum Redpath, MD
- Recruiting
Institut universitaire de cardiologie et de pneumologie Québec - Université Laval (IUCPQ-ULaval)
Québec, Quebec, G1V4G5
Francois Philippon, MD
- Recruiting
Hôpital Fleurimont
Sherbrooke, Quebec, J1H5N4
Felix Ayala-Paredes, MD
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario
Christopher Cheung, MD
- Recruiting
Victoria Cardiac Arrhythmia Trials
Victoria, British Columbia
Markus Sikkel, MD
About this study
Official title: Resynchronization for Ambulatory Heart Failure Trial in Patients With Chronic Atrial Fibrillation - Pharmacological Rate Control vs. Pace and Ablate With Conduction System Pacing
Atrial fibrillation (AF) is an irregular heartbeat that can cause symptoms of skipped beats, shortness of breath, stroke, or in some cases fluid in the lungs or legs. Treating AF is mostly to do with slowing the heart rate down so that the heart can get a chance to regain some energy. In some cases, slowing the heart rate is not easy to achieve as some patients find it difficult to tolerate medications and suffer side effects from these treatments. In these instances, there might be a possibility to permanently control the heart rate by implanting a pacemaker in the heart and intentionally damaging a regulatory region of the heart called the atrioventricular (AV) node. Damaging the AV node by a procedure called ablation results in the AF not being able to influence the bottom chambers (the ventricles) resulting in a slow rhythm. Therefore, if a pacemaker is implanted then the heart rate can be completely regulated by the pacemaker.
A complex pacemaker that stimulates both the right and left ventricles simultaneously (BiVP) has been used for the last decade prior to AV node ablation. More recently, a technique has been designed to reduce the number of leads in the heart, reduce procedure time and have a similar effect on the heart called Conduction System Pacing (CSP). There is not enough existing evidence to show that a pace and ablate strategy is superior to optimal medical therapy. We intend to compare the efficacy of CSP with AV node ablation to optimal medical therapy for treating AF.
- Conditions
- Atrial Fibrillation, Heart Failure, Pacemaker, Arrhythmia Atrial
- Being tested
- Pace and Ablate, Medication
- Medical subject headings
- Atrial Fibrillation, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pace and AblateDevice
Also called P&A, pacemaker and atrioventricular node ablation
Conduction System Pacing (CSP) followed by AtrioVentricular Node Ablation (AVNA)
MedicationDrug
Also called Optimal heart failure therapy
Optimization of heart failure therapies includes maximum tolerated doses of beta-blockers, aldosterone antagonists, ACE inhibitors, ARB, diuretics, ARNis
| Study group | Role | What they receive |
|---|---|---|
| Pharmacological Therapy | Active comparator | Patients randomized to pharmacology rate control will receive guideline-directed HF management across all ranges of LVEF, including appropriate rate control medications. ICD will be inserted in those patients who have LVEF ≤35% Receives: Drug: Medication |
| P&A-CSP | Experimental | Patients randomized to P\&A-CSP will receive a CSP and ICD if LVEF ≤35% within 10 working days of randomization. Catheter AVNA will be performed within 4 weeks. Receives: Device: Pace and Ablate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Winratio
Reduction in the hierarchical composite outcomes of all-cause mortality and HF events frequency, improvement in NT-proBNP and improvement in QOL.
Measured: 12 months
Secondary outcomes (8)
All-cause mortality
Mortality from any cause within the 12 month of follow up period
Measured: 12 months
Cardiovascular mortality
Mortality attributed to cardiovascular causes within 12 month follow up period
Measured: 12 months
Number of heart failure events
Heart failure related presentations to health care facilities necessitating intravenous diuretics or overnight stay
Measured: 12 months
All-cause hospitalization
ER admission or overnight stay
Measured: 12 months
Quality of Life -Kansas City Cardiomyopathy Questionairre (KCCQ)
Change in Kansas HF score from baseline. KCCQ is a 23-item self-administered questionnaire that measures the participant's perception of their health status, including their HF symptoms, impact on physical and social function and how their HF impacts the quality of life (QoL). KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), QoL (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.
Measured: 6 months
Exercise
Change in 6 minute walk distance from baseline
Measured: 6 months
Biochemical marker
Change in NTproBNP from baseline
Measured: 6 months
Cognitive assessment
Change in cognitive assessment scores from baseline
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start25 Apr 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Habib Khan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Habib Khan, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299514
- Sponsor's protocol ID
- 4754
- Acronym
- RAFT-P&A RCT
- Status last verified
- Jan 2026
- First submitted
- 1 Mar 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resynchronization for Ambulatory Heart Failure Trial in Patients With Chronic Atrial Fibrillation - Pharmacological Rate Control vs. Pace and Ablate With Conduction System Pacing
- ClinicalTrials.gov ID
- NCT06299514
- Acronym / sponsor ID
- RAFT-P&A RCT / 4754
- Conditions
- Atrial Fibrillation, Heart Failure, Pacemaker, Arrhythmia Atrial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Habib KhanUniversity, hospital or other
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 8 Mar 2024 (actual)
- 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) is an irregular heartbeat that can cause symptoms of skipped beats, shortness of breath, stroke, or in some cases fluid in the lungs or legs. Treating AF is mostly to do with slowing the heart rate down so that the heart can get a chance to regain some energy. In some cases, slowing the heart rate is not easy to achieve as some patients find it difficult to tolerate medications and suffer side effects from these treatments. In these instances, there might be a possibility to permanently control the heart rate by implanting a pacemaker in the heart and intentionally damaging a regulatory region of the heart called the atrioventricular (AV) node. Damaging the AV node by a procedure called ablation results in the AF not being able to influence the bottom chambers (the ventricles) resulting in a slow rhythm. Therefore, if a pacemaker is implanted then the heart rate can be completely regulated by the pacemaker.
A complex pacemaker that stimulates both the right and left ventricles simultaneously (BiVP) has been used for the last decade prior to AV node ablation. More recently, a technique has been designed to reduce the number of leads in the heart, reduce procedure time and have a similar effect on the heart called Conduction System Pacing (CSP). There is not enough existing evidence to show that a pace and ablate strategy is superior to optimal medical therapy. We intend to compare the efficacy of CSP with AV node ablation to optimal medical therapy for treating AF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacological Therapy | Active comparator | Drug: MedicationPatients randomized to pharmacology rate control will receive guideline-directed HF management across all ranges of LVEF, including appropriate rate control medications. ICD will be inserted in those patients who have LVEF ≤35% |
| P&A-CSP | Experimental | Device: Pace and AblatePatients randomized to P\&A-CSP will receive a CSP and ICD if LVEF ≤35% within 10 working days of randomization. Catheter AVNA will be performed within 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with permanent AF/persistent AF (in AF)
- Patients with NYHA Class II -IVa HF symptoms
- Guideline driven medical therapy (GDMT) for HF for at least 3 months:
Key exclusion criteria (14 listed)
- In hospital patients needing intensive care or intravenous inotropic agent in the last 4 days
- Patients with a life expectancy of ≤ 1 year from non-cardiac cause or anticipating a transplant within 1 year
- Acute coronary syndrome <4 weeks or coronary revascularization <3months
- Unable or unwilling to provide informed consent
- Uncorrected primary valvular disease or prosthetic tricuspid valve
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 |
|---|---|---|
| Pace and AblateAlso: P&A, pacemaker and atrioventricular node ablationConduction System Pacing (CSP) followed by AtrioVentricular Node Ablation (AVNA) | Device | P&A-CSP |
| MedicationAlso: Optimal heart failure therapyOptimization of heart failure therapies includes maximum tolerated doses of beta-blockers, aldosterone antagonists, ACE inhibitors, ARB, diuretics, ARNis | Drug | Pharmacological Therapy |
Primary outcome
Winratio
Time frame: 12 months
Reduction in the hierarchical composite outcomes of all-cause mortality and HF events frequency, improvement in NT-proBNP and improvement in QOL.
8 secondary outcomes
All-cause mortality
Time frame: 12 months
Cardiovascular mortality
Time frame: 12 months
Number of heart failure events
Time frame: 12 months
All-cause hospitalization
Time frame: 12 months
Quality of Life -Kansas City Cardiomyopathy Questionairre (KCCQ)
Time frame: 6 months
Exercise
Time frame: 6 months
Biochemical marker
Time frame: 6 months
Cognitive assessment
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
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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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pace and Ablate and Medication in people with Atrial Fibrillation and Heart Failure, run by Habib Khan at 12 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 5 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: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Habib R Khan, MBBS, PhD (519-6633746, habib.khan@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Winratio (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2026.