Treating Atrial Fibrillation in Heart Failure With Preserved Ejection Fraction: Ablation or Medication

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation (AF); Rate Control; Heart Failure With Preserved Ejection Fraction (HFPEF); Heart Failure With Mildly Reduced Ejection Fraction; Rhythm Control
• Intervention / Treatment: Procedure: Catheter Ablation for Atrial Fibrillation; Drug: Rate Control Medications (beta-blockers, calcium channel blockers, digoxin)

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Hamilton, BSC, MAHSR; Phone Number: 902-473-7226; Email: laura.hamilton@nshealth.ca
• Study Contact Backup: Name: Katie Kawulka, BScN, RN; Phone Number: 902-473-7684; Email: katie.kawulka@nshealth.ca

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • Recruiting
      • QEII HSC
      • Principal Investigator: Ratika Parkash, MD, FRCPC
      • Contact: Laura Hamilton, BSC, MAHSR; Phone Number: 902-473-7226; Email: laura.hamilton@nshealth.ca
      • Contact: Katie Kawulka, BScN, RN; Phone Number: 902-473-7684; Email: katie.kawulka@nshealth.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)
• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Catheter Ablation (Rhythm Control Group); Participants in this group will undergo catheter ablation procedure, scheduled within 4 weeks of joining the study.	Procedure: Catheter Ablation for Atrial Fibrillation; 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.
Active Comparator: Medical Therapy (Rate Control Group); Participants in this group will take medications, with the dosages adjusted over the first few weeks to find the correct dosage.	Drug: Rate Control Medications (beta-blockers, calcium channel blockers, digoxin); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Up to 12 months post-randomization
All-Cause Mortality	Death from any cause	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.	Up to 12 months
Quality of Life: EQ-5D (Euroquol 5D Questionnaire)	EQ5D Will include responses from the Euroquol 5D questionnaire	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)	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)	Baseline, 12 months
Atrial Fibrillation Burden	Proportion of time in atrial fibrillation as measured by Holter monitoring and symptom-triggered ECG recordings	Baseline, 3, 6, and 12 months
Change in NT-proBNP levels	Change in plasma NT-proBNP levels from baseline to follow-up	Baseline, 12 months
Change in Left Ventricular Ejection Fraction (LVEF)	Change in LVEF as measured by echocardiography	Baseline, 12 months
Exercise Capacity (6-Minute Walk Distance)	Change in distance walked in 6 minutes from baseline to follow-up	Baseline, 12 months
Recruitment Metrics	Recruitment ration of male vs. female participants, refusal rates and reasons.	Throughout 12-month recruitment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Complications	Symptomatic pulmonary vein stenosis, atrio-esophageal fistula, pericardial effusion requiring pericardiocentesis, major bleeding requiring transfusion.	Up to 30 days post-ablation procedure
Antiarrhythmic Drug Adverse Events	Incidence of drug-related toxicities (e.g., thyroid, hepatic, pulmonary, proarrhythmia)	Up to 12 months
All-Cause Death	Number of deaths from any cause	Up to 12 months

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority
• Collaborators: Heart and Stroke Foundation of Canada

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Actual): December 9, 2025

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Membrane Transport Modulators; Adrenergic Agents; Adrenergic Antagonists; Therapeutics; Surgical Procedures, Operative; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Carbohydrates; Polycyclic Compounds; Glycosides; Steroids; Fused-Ring Compounds; Ablation Techniques; Radiofrequency Ablation; Radiofrequency Therapy; Cardiovascular Agents; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Digoxin; Adrenergic beta-Antagonists; Calcium Channel Blockers; Catheter Ablation
• Other Study ID Numbers: CABANA-RAFT HF; 1032000 (Other Identifier: Nova Scotia Health REB File #)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No