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

Nova Scotia Health Authority84 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atrial Fibrillation (AF)Heart Failure With Mildly Reduced Ejection Fraction Heart Failure With Preserved Ejection Fraction (HFPEF)Rate Control

Interventions

Catheter Ablation for Atrial FibrillationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 12 months after randomization

Secondary Outcomes

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).

Time frame: Up to 12 months post-randomization

All-Cause Mortality

Death from any cause

Time frame: 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.

Time frame: Up to 12 months

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

EQ5D Will include responses from the Euroquol 5D questionnaire