Optimising Pacing Therapy, Integrated Medical Therapy, and Catheter AbLation for Atrial Fibrillation in Heart Failure Trial

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of British Columbia

About this trial

Atrial Fibrillation (AF) and Heart Failure (HF) are colliding global cardiovascular epidemics, individually impairing quality of life and cardiac performance, as well as increasing the risk of hospitalisation and mortality. When AF and HF co-exist, disease progression accelerates and the adverse outcomes are magnified, leading to incrementally higher morbidity, mortality, and healthcare expenditure. The management of AF has been dichotomised into the restoration and maintenance of sinus rhythm ("Rhythm control") or acceptance of AF with control of the ventricular response ("Rate control"). Previous studies suggested that pharmacologic rhythm control and pharmacologic rate control confer similar survival and morbidity outcomes in patients with significant left ventricular dysfunction. Recognising the limitations of pharmacotherapy, more recent studies have examined the utility of catheter ablation procedures, either designed to restore and maintain sinus rhythm (e.g., catheter-based pulmonary vein isolation) or control the ventricular response (e.g., pacemaker implantation in combination with catheter ablation of the atrioventricular junction). Compared to pharmacotherapy, these studies have suggested that catheter ablation may provide sustained improvements in quality of life, decreased hospitalisation and, potentially, improved survival for patients with co-existing AF and HF. However, these studies were performed prior to the modern era of quadruple LV enhancing therapy (beta-blocker, an angiotensin receptor-neprilysin inhibitor, mineralocorticoid receptor antagonist, and an SGLT2 inhibitor). The true impact of catheter-based interventions, and thus the optimal management of AF for patients with co-existing HF is not known. The investigators propose a randomised controlled trial to definitively answer the question regarding the optimal invasive treatment of AF in patients with heart failure with reduced ejection fraction (HFrEF - LVEF ≤ 40%).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age of 18 years or older on the date of Informed Consent,

Atrial fibrillation,

Left ventricular ejection fraction of 40% or less, measured within 6 months of enrollment,

Receiving stable foundational HF quadruple therapy at maximally tolerated dose,

Disqualifiers

Anticipated life expectancy less than one year from the consent date,

Continuous atrial fibrillation of >1 year in duration,

Left atrial anteroposterior diameter > 6 cm, volume > 100 mL, or volume index > 60 mL/m2,

Previous left atrial ablation or left atrial surgery,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pulmonary Vein Isolation

    Device

    PVI

  • Atrioventricular Node Ablation

    Procedure/Surgery

    AVJ

  • Pharmacological Rate Control

    Drug

    Rate

Treatment groups

1,056 Participants
are divided into 3 treatment groups
Group A: Optimal Medical TherapyActive comparator 1 intervention
Group B: Catheter Ablation with The Goal of Sinus Rhythm Restoration (Pulmonary Vein Isolation)Active comparator 1 intervention
Group C: Catheter Ablation with The Goal of Ventricular Rate Control and Regularization (AVJ Ablation)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Composite of cardiovascular mortality, stroke, and total number of heart failure events

Time frame
5 years

Secondary outcomes

1

Composite of ejection fraction, distance on the 6-minute walk test, and QOL score

Time frame
1 year
2

Time to death from any cause

Time frame
5 years
3

Time to death from cardiovascular cause

Time frame
5 years
4

Number of Participants with unplanned emergency department visit or all-cause hospitalisation

Time frame
5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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