APAF-CRT

Rationale: AV junction ablation cannot be recommended as a first-line treatment for all patients with permanent AF and refractory heart failure as an alternative to pharmacological rate control therapy. Indeed, evidence of superiority of AV junction ablation strategy as opposed to optimal pharmacological rate control therapy exists only for symptoms of AF, but not for heart failure occurrence, hospitalization, morbidity and mortality. Thus, both strategies are currently recommended by guidelines and the choice between them is left to physician’s preference. The need for a comparison between pharmacological and non-pharmacological strategy represents the rationale of the APAF-CRT trial.

Objective: To determine if an approach consisting of AV junction ablation and biventricular pacing is superior to optimal pharmacological rate control therapy in reducing at 24 months a combined endpoint of: mortality due to heart failure, hospitalization for heart failure or uncontrolled intolerable AF, worsening heart failure.

Study design: randomized, multicenter, prospective study

Study population: patients with permanent AF (> 6 months) and severely symptomatic (AF-related symptoms), refractory to drug therapy for rate control

Intervention: AV junction ablation and biventricular pacing (Study Arm) vs. optimal pharmacological rate control therapy (Control Arm).

Main study parameters/endpoints:

The primary outcome will be if an approach consisting of AV junction ablation and biventricular pacing is superior to optimal pharmacological rate control therapy in reducing at 24 months a combined endpoint of: mortality due to heart failure, hospitalization for heart failure or uncontrolled intolerable AF, worsening heart failure.

Secondary endpoints include whether this strategy is superior in reducing at 24 months total mortality, total hospitalizations, hospitalizations for heart failure or uncontrolled intolerable AF, or worsening heart failure; improving symptoms, superior in reducing total mortality at 48 months.