Treating Atrial Fibrillation in Heart Failure With Preserved Ejection Fraction: Ablation or Medication
NCT ID: NCT07272902
Last Updated: 2025-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
84 participants
INTERVENTIONAL
2025-12-31
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Catheter Ablation (Rhythm Control Group)
Participants in this group will undergo catheter ablation procedure, scheduled within 4 weeks of joining the study.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Heart and Stroke Foundation of Canada
OTHER
Nova Scotia Health Authority
OTHER
Responsible Party
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Ratika Parkash
Principal Investigator
Locations
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QEII HSC
Halifax, Nova Scotia, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1032000
Identifier Type: OTHER
Identifier Source: secondary_id
CABANA-RAFT HF
Identifier Type: -
Identifier Source: org_study_id
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