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

February 12, 2026 updated by: Ratika Parkash, Nova Scotia Health Authority

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Recruiting
        • QEII HSC
        • Principal Investigator:
          • Ratika Parkash, MD, FRCPC
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 months after randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Up to 12 months post-randomization
All-Cause Mortality
Time Frame: Up to 12 months
Death from any cause
Up to 12 months
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.
Up to 12 months
Quality of Life: EQ-5D (Euroquol 5D Questionnaire)
Time Frame: Baseline, 12 months
EQ5D Will include responses from the Euroquol 5D questionnaire
Baseline, 12 months
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)
Baseline, 12 months
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)
Baseline, 12 months
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
Baseline, 3, 6, and 12 months
Change in NT-proBNP levels
Time Frame: Baseline, 12 months
Change in plasma NT-proBNP levels from baseline to follow-up
Baseline, 12 months
Change in Left Ventricular Ejection Fraction (LVEF)
Time Frame: Baseline, 12 months
Change in LVEF as measured by echocardiography
Baseline, 12 months
Exercise Capacity (6-Minute Walk Distance)
Time Frame: Baseline, 12 months
Change in distance walked in 6 minutes from baseline to follow-up
Baseline, 12 months
Recruitment Metrics
Time Frame: Throughout 12-month recruitment
Recruitment ration of male vs. female participants, refusal rates and reasons.
Throughout 12-month recruitment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Up to 30 days post-ablation procedure
Antiarrhythmic Drug Adverse Events
Time Frame: Up to 12 months
Incidence of drug-related toxicities (e.g., thyroid, hepatic, pulmonary, proarrhythmia)
Up to 12 months
All-Cause Death
Time Frame: Up to 12 months
Number of deaths from any cause
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nova Scotia Health Authority

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Heart and Stroke Foundation of Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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