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

NCT07272902 | Recruiting

• 2 other identifiers: CABANA-RAFT HF1032000
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Composite of Cardiovascular Mortality and Heart Failure Hospitalization

  Up to 12 months post-randomization

• All-Cause Mortality

  Up to 12 months

• Cardiovascular Hospitalizations and ED Visits (Non-HF)

  Up to 12 months

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

  Baseline, 12 months

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

  Baseline, 12 months

Other Outcomes (3)

• Procedural Complications

  Up to 30 days post-ablation procedure

• Antiarrhythmic Drug Adverse Events

  Up to 12 months

• All-Cause Death

  Up to 12 months

Study Arms (2)

Catheter Ablation (Rhythm Control Group)

ACTIVE COMPARATOR

Participants in this group will undergo catheter ablation procedure, scheduled within 4 weeks of joining the study.

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.

Drug: Rate Control Medications (beta-blockers, calcium channel blockers, digoxin)

Interventions

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.

Catheter Ablation (Rhythm Control Group)

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.

Medical Therapy (Rate Control Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Heart and Stroke Foundation of Canada: collaborator

Study Sites (1)

QEII HSC

Halifax, Nova Scotia, B3H 3A7, Canada

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation; Adrenergic beta-Antagonists; Calcium Channel Blockers; Digoxin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Cardiovascular Agents; Therapeutic Uses; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Central Study Contacts

Laura Hamilton, BSC, MAHSR

CONTACT

902-473-7226; laura.hamilton@nshealth.ca

Katie Kawulka, BScN, RN

CONTACT

902-473-7684; katie.kawulka@nshealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 9, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)