Atrial Fibrillation (AF)NCT07272902
Treating Atrial Fibrillation in Heart Failure With Preserved Ejection Fraction: Ablation or Medication
A study testing Catheter Ablation for Atrial Fibrillation in people with Atrial Fibrillation (AF) and Heart Failure With Mildly Reduced Ejection Fraction, run by Nova Scotia Health Authority at 4 sites in Canada.
Trial summary
This study is testing two different ways of treating atrial fibrillation (AF) in people who also have heart failure with mildly reduced or preserved heart function. Patients will randomly be assigned to either rhythm control using catheter ablation or rate control using medicines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Heart Failure With Mildly Reduced Ejection Fraction, Heart Failure With Preserved Ejection Fraction (HFPEF)
- What is being tested?
- Catheter Ablation for Atrial Fibrillation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 4 sitesCanada
- Study dates
- 1 Jan 2026to Oct 2027
- Phase
- Interventional
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
- Age ≥18 years
- Diagnosis of atrial fibrillation (documented on Holter, rhythm strip, or ECG)
- New York Heart Association (NYHA) class II-III heart failure
- Left ventricular ejection fraction (LVEF) >40%
- Meet specific NT-proBNP criteria:
- If HF hospitalization within 6 months prior to screening: NT-proBNP >200 pg/ml (if not in AF at screening) or >600 pg/ml (if in AF at screening)
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- Otherwise: NT-proBNP >300 pg/ml (if not in AF at screening) or >900 pg/ml (if in AF at screening)
- On stable guideline-directed medical therapy for ≥1 month
- On stable diuretic dose for ≥2 weeks
- Suitable for either ablation-based rhythm control or rate control strategy
Who cannot join
- Permanent atrial fibrillation diagnosis
- Prior catheter ablation for atrial fibrillation
- NYHA class IV heart failure
- Rheumatic heart disease
- Moderate or severe mitral stenosis
- Mechanical mitral valve
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- Severe aortic stenosis or severe aortic/mitral regurgitation
- Renal failure requiring dialysis
- Contraindication to oral anticoagulation
- Infiltrative cardiomyopathies
- Complex congenital heart disease
- Untreated thyroid disease
- Acute coronary syndrome or coronary artery bypass surgery within 12 weeks
- Participation in another clinical trial
- Inability to provide informed consent
- Other serious non-cardiovascular condition with life expectancy ≤1 year
- Age <18 years
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites, 4 recruiting
- Recruiting
QEII HSC
Halifax, Nova Scotia, B3H 3A7
Laura Hamilton, BSC, MAHSR, 902-473-7226, laura.hamilton@nshealth.ca
Katie Kawulka, BScN, RN, 902-473-7684, katie.kawulka@nshealth.ca
- Recruiting
Hamilton Health Sciences
Hamilton, Ontario
Jorge Wong
- Recruiting
London Health Sciences Centre
London, Ontario
Habib Khan
- Recruiting
Montreal Heart Institute
Montreal, Quebec
Lena Rivard
About this study
Official title: A Randomized Ablation-based Atrial Fibrillation Rhythm Control Versus Rate Control Trial in Patients With Heart Failure and Preserved Ejection Fraction (CABANA-RAFT HF): A Pilot Study
This study is testing two different ways of treating atrial fibrillation (AF) in people who also have heart failure with mildly reduced or preserved heart function. Patients will randomly be assigned to either rhythm control using catheter ablation or rate control using medicines. The pilot phase will determine if a larger study can be successfully carried out to see which approach better improves survival, reduces hospitalizations, and enhances quality of life.
- Conditions
- Atrial Fibrillation (AF), Heart Failure With Mildly Reduced Ejection Fraction, Heart Failure With Preserved Ejection Fraction (HFPEF), Rate Control, Rhythm Control
- Being tested
- Catheter Ablation for Atrial Fibrillation, Rate Control Medications (beta-blockers, calcium channel blockers, digoxin)
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter Ablation for Atrial FibrillationProcedure or surgery
Participants randomized to this arm will undergo catheter ablation within 4 weeks of randomization. Pulmonary vein isolation is required; additional ablation strategies may be applied at investigator discretion. Guideline-directed medical therapy for atrial fibrillation and heart failure will also be provided.
Rate Control Medications (beta-blockers, calcium channel blockers, digoxin)Drug
Participants randomized to this arm will receive pharmacologic therapy to achieve guideline-recommended heart rate control (resting HR <80 bpm, <110 bpm with exercise). Therapy may include beta-blockers, non-dihydropyridine calcium channel blockers, or digoxin. If adequate control is not achieved with medication, AV nodal ablation and pacing may be used. Guideline-directed medical therapy for atrial fibrillation and heart failure will also be provided.
| Study group | Role | What they receive |
|---|---|---|
| Catheter Ablation (Rhythm Control Group) | Active comparator | Participants in this group will undergo catheter ablation procedure, scheduled within 4 weeks of joining the study. Receives: Procedure: Catheter Ablation for Atrial Fibrillation |
| Medical Therapy (Rate Control Group) | Active comparator | Participants in this group will take medications, with the dosages adjusted over the first few weeks to find the correct dosage. Receives: Drug: Rate Control Medications (beta-blockers, calcium channel blockers, digoxin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Trial Conduct
Recruitment rate (patients recruited per center per month) and crossover rate (percentage of participants switching study arms). Feasibility will be defined as ≥0.7 patients enrolled per center per month and ≤10% crossover.
Measured: 12 months after randomization
Secondary outcomes (11)
Composite of Cardiovascular Mortality and Heart Failure Hospitalization
Time to first event of cardiovascular death (due to MI, sudden cardiac death, HF, stroke, CV procedures, CV bleeding, or other CV cause) or hospitalization for heart failure (admission >24h, ED visit, or unscheduled IV diuretic administration).
Measured: Up to 12 months post-randomization
All-Cause Mortality
Death from any cause
Measured: Up to 12 months
Cardiovascular Hospitalizations and ED Visits (Non-HF)
Number of hospitalizations or emergency department visits for other cardiovascular causes, including atrial fibrillation.
Measured: Up to 12 months
Quality of Life: EQ-5D (Euroquol 5D Questionnaire)
EQ5D Will include responses from the Euroquol 5D questionnaire
Measured: Baseline, 12 months
Quality of Life: AFEQT (Atrial Fibrillation Effect on Quality of Life) Questionnaire
AFEQT- Atrial Fibrillation Effect on Quality of Life Questionnaire (Scored 0-100, 0 is complete disability, 100 is no disability)
Measured: Baseline, 12 months
Quality of life- KCCQ-12 (Kansas City Cardiomyopathy Questionnaire-12)
KCCQ-12- Kansas City Cardiomyopathy Questionnaire-12 (0-100, 0 is very poor, 100 is excellent)
Measured: Baseline, 12 months
Atrial Fibrillation Burden
Proportion of time in atrial fibrillation as measured by Holter monitoring and symptom-triggered ECG recordings
Measured: Baseline, 3, 6, and 12 months
Change in NT-proBNP levels
Change in plasma NT-proBNP levels from baseline to follow-up
Measured: Baseline, 12 months
Change in Left Ventricular Ejection Fraction (LVEF)
Change in LVEF as measured by echocardiography
Measured: Baseline, 12 months
Exercise Capacity (6-Minute Walk Distance)
Change in distance walked in 6 minutes from baseline to follow-up
Measured: Baseline, 12 months
Recruitment Metrics
Recruitment ration of male vs. female participants, refusal rates and reasons.
Measured: Throughout 12-month recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Jan 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies 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
- Model description
- This trial is a pilot feasibility trial intended to lead into a larger, definitive trial as the trial is comparing two treatments already in clinical use.
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Responsible party
- Principal investigator, Ratika Parkash, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272902
- Sponsor's protocol ID
- CABANA-RAFT HF
- Other IDs
- 1032000
- Status last verified
- Oct 2026
- First submitted
- 24 Nov 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No