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NCT Number: NCT07272902

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

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.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Heart Failure With Mildly Reduced Ejection Fraction Heart Failure With Preserved Ejection Fraction (HFpEF) Pathologic Processes Pathological Conditions, Signs and Symptoms Rate Control Rhythm Control

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Catheter Ablation for Atrial Fibrillation

Procedure

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.

Primary outcomes

  1. Feasibility of Trial Conduct

    Time frame: 12 months after randomization

    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.

Secondary outcomes

  1. Composite of Cardiovascular Mortality and Heart Failure Hospitalization

    Time frame: Up to 12 months post-randomization

    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).

  2. All-Cause Mortality

    Time frame: Up to 12 months

    Death from any cause

  3. Cardiovascular Hospitalizations and ED Visits (Non-HF)

    Time frame: Up to 12 months

    Number of hospitalizations or emergency department visits for other cardiovascular causes, including atrial fibrillation.

  4. Quality of Life: EQ-5D (Euroquol 5D Questionnaire)

    Time frame: Baseline, 12 months

    EQ5D Will include responses from the Euroquol 5D questionnaire

  5. Quality of Life: AFEQT (Atrial Fibrillation Effect on Quality of Life) Questionnaire

    Time frame: Baseline, 12 months

    AFEQT- Atrial Fibrillation Effect on Quality of Life Questionnaire (Scored 0-100, 0 is complete disability, 100 is no disability)

  6. Quality of life- KCCQ-12 (Kansas City Cardiomyopathy Questionnaire-12)

    Time frame: Baseline, 12 months

    KCCQ-12- Kansas City Cardiomyopathy Questionnaire-12 (0-100, 0 is very poor, 100 is excellent)

  7. Atrial Fibrillation Burden

    Time frame: Baseline, 3, 6, and 12 months

    Proportion of time in atrial fibrillation as measured by Holter monitoring and symptom-triggered ECG recordings

  8. Change in NT-proBNP levels

    Time frame: Baseline, 12 months

    Change in plasma NT-proBNP levels from baseline to follow-up

  9. Change in Left Ventricular Ejection Fraction (LVEF)

    Time frame: Baseline, 12 months

    Change in LVEF as measured by echocardiography

  10. Exercise Capacity (6-Minute Walk Distance)

    Time frame: Baseline, 12 months

    Change in distance walked in 6 minutes from baseline to follow-up

  11. Recruitment Metrics

    Time frame: Throughout 12-month recruitment

    Recruitment ration of male vs. female participants, refusal rates and reasons.

Other outcomes

  1. Procedural Complications

    Time frame: Up to 30 days post-ablation procedure

    Symptomatic pulmonary vein stenosis, atrio-esophageal fistula, pericardial effusion requiring pericardiocentesis, major bleeding requiring transfusion.

  2. Antiarrhythmic Drug Adverse Events

    Time frame: Up to 12 months

    Incidence of drug-related toxicities (e.g., thyroid, hepatic, pulmonary, proarrhythmia)

  3. All-Cause Death

    Time frame: Up to 12 months

    Number of deaths from any cause

Study contacts

Contact information is provided by the study sponsor or research team.

Katie Kawulka, BScN, RN

CONTACT

[email protected]

902-473-7684

Laura Hamilton, BSC, MAHSR

CONTACT

[email protected]

902-473-7226

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Collaborators

  • Heart and Stroke Foundation of Canada

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 9, 2025
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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